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8 Best Healthcare Resume Writing Services (2024)

Find the best resume writing services for healthcare. Compare cost and customer reviews of the top healthcare resume writing services.

2024 Winners: Add your badge to your marketing materials.

There are thousands of resume writers out there. It’s a challenge to know which ones are really the best.

As a healthcare professional you simply can’t settle for average.

Not all resume writers can make the best use of medical terminology. Effective use of the industry-specific wording is essential for a targeted healthcare resume.

The last thing you want is to waste resources on a service that provides a botched treatment to your resume.

That’s why we have created this shortlist of the best healthcare resume writers for you.

You can also check out our list of the best Nursing or Physician Resume Writing Services .

Best Healthcare Resume Writers

Best resume services for healthcare.

How We Choose Winners

Each of the healthcare resume services below was reviewed by a Certified Professional Resume Writer (CPRW) taking into consideration the following:

The cost of the service compared to other healthcare resume writers.

The speed at which the resume is completed.

Overall experience, awards, and certifications.

The design, style, and overall look of the resume.

Guarantees, number of edits, and reviews.

This list was hand-curated to serve all healthcare professions. These jobs include physician, therapist, medical technologist, medical assistant, anesthesiologist, and more.

Average Healthcare Resume Cost

Healthcare resume writer reviews.

Find My Profession

Find My Profession is much more than a resume writing service. They are a global career services company whose work has been featured on sites like Forbes, Inc., Zety, Fast Company, and more.

With their team of elite resume writers who have experience in over 85 industries and professions, they can match you with a writer who understands your unique background and experience. Additionally, every resume comes with a one-on-one phone consultation with your writer.

Find My Profession has an impressive track record of successfully landing clients jobs at top companies such as Apple, Amazon, EA, Oracle, GM, Facebook, DoJ, Morgan Stanley, and Tesla.

Their 900+ 5-star reviews speak to their commitment to delivering high-quality service. They also offer a 60-day interview guarantee and ensure that every resume created is Applicant Tracking System (ATS) compatible and highly customized to meet your specific needs.

You will work one-on-one with an elite and certified resume writer based in the U.S. Find My Profession is committed to ensuring that every client is 100% satisfied with their resume, which is why they do not limit the number of edits or time spent working with your writer.

Find My Profession is a virtual company allowing them to provide services worldwide. While they do not have a physical office for in-person visits, they ensure direct communication with your writer through email and phone calls.

4.9/5 based on 521 Trustpilot reviews 4.9/5 based on 319 Sitejabber reviews 4.9/5 based on 151 Google reviews 5/5 based on 52 Facebook reviews

3 – 5 business days (can expedite to 2 business days)

$395 – $995

(831) 888-0967 or [email protected]

Check out some of our 5-star reviews:

Alex on January 4, 2024

Resume & LinkedIn Profile

Belda Villalon on July 1, 2022

Michael on December 19, 2023

Exceptional resume

Michelle T on November 10, 2022

Professional Resume

Brigit on October 25, 2023

Highest quality of work

Beh on September 20, 2021

Professional. Experts…

Matt B on July 17, 2023

Excellent Experience

Chad B on May 2, 2022

Wonderful investment

ResumeZest is trusted by professionals from companies like Google, Amazon, Apple, Oracle, GE, Adobe, Uber, and Facebook. Their resume writing team has written resumes for more than 75 industries. A 60-day interview guarantee backs up every resume they write. Each resume is also ATS compliant and keyword-optimized.

ResumeZest is a very well-rounded company. They offer affordable pricing and quick turnaround times. You will work with a high-quality, certified writer and receive excellent customer service. They are also members of the Professional Association of Resume Writers and Career Coaches (PARW/CC).

ResumeZest is one of the newer companies on this list. While they do a great job and their writers have many years of experience, the company was only founded in 2020.

4.8/5 based on 175 Trustpilot reviews 4.8/5 based on 93 Google reviews 4.9/5 based on 91 Sitejabber reviews 5/5 based on 12 Facebook reviews 5/5 based on 4 Yelp reviews

$279 – $479

(888) 530-4911 or [email protected]

Need Help With Your Job Search?

Did you know there are companies you can hire to help with your job search? Whether you need resume help or want someone to apply to jobs for you, we’ve reviewed the 20 best agencies to help you find a job.

Nurse Resume Writing Service

Nurse Resume Writing Service is run by Rosa Elizabeth Vargas. Rosa has 15 years of experience in healthcare resume writing. She has a BSN-level nursing background. Rosa prides herself in providing medically accurate nurse and healthcare resume writing services. She is also a 4x certified resume writer.

Each and every resume creation is overseen by Rosa herself. She has a small team of two certified assistant writers and a professional proofreader. Rosa has won multiple Toast of The Resume Industry (TORI) awards throughout her career.

The website doesn’t provide any details about the revision policy or the number of revisions you will get with the resume packages. Also, they do not provide any satisfaction guarantees.

7 – 10 business days

$385 – $1,095

(321) 704-7209 or [email protected]

ReadyHire Medical Resumes

ReadyHire Medical Resumes is a specialized medical resume writing service for healthcare professionals. The company has over 25 years of experience in medical resume writing. They have worked with individuals in all areas of healthcare, including pharmacists, administrators, nurses, anesthesiologists, and more.

The initial consultation is free. You can use this opportunity to speak with your resume writer, discuss concerns, and set out a strategy. All the writers are senior executive resume writers dedicated to serving medical professionals.

There is no resume package readily available to order on the website. You have to email your resume or fill out a questionnaire to get started.

A few days (can expedite)

(800) 730-3244 or [email protected]

iHire Healthcare Administration

iHire Healthcare Administration is a niche job board dedicated to the healthcare industry. They offer healthcare resume writing services as well as resume formatting. Their resume writers are Certified Advanced Resume Writers (CARW) and Certified Master Resume Writers (CMRW).

This company offers to work with you until you are 100% satisfied with your healthcare resume. They have award-winning professional resume writers on staff. You can see a before and after presentation of a healthcare resume sample on their site.

You have to fill out a questionnaire instead of having a phone consultation with your writer. Also, there’s only one resume package listed. The reviews we found are for the parent company, not specifically for healthcare resumes.

4.2/5 based on 813 Trustpilot reviews 4.4/5 based on 545 Sitejabber reviews 3.3/5 based on 18 Google reviews 2.75/5 based on 16 BBB reviews

5 – 7 business days

(877) 316-3118

Joe Connor Career Marketing

Joe Connor Career Marketing is owned by Joe Connor. Joe has been helping job seekers achieve career goals for more than 10 years. He is also a career instructor for the San Diego Community College District. Joe specializes in healthcare and pharma resume writing and career marketing.

Every new client is offered a free consultation. The turnaround time for resume writing is quite fast compared to other services on our list. Special discounts are available for U.S. military personnel and first responders.

The service doesn’t offer any interview or satisfaction guarantees. Also, the website doesn’t display any resume samples.

4.8/5 based on 26 Google reviews 3.5/5 based on 6 Yelp reviews

24 – 48 hours

$100 – $300

(858) 531-7128 or [email protected]

Is Your Resume Working Properly?

If you are having trouble landing interviews, it might be time to hire a professional resume writer. Check out our list of the 750+ best resume writers and start landing more interviews!

TopStack Resume

TopStack Resume was founded by Steve Marcum in 2018. All of their team members are based in the United States. It is one of the rare resume services that allow you to pay only after you are satisfied with their services. This is a good, low-cost option for entry-level healthcare professionals.

You will get unlimited revisions with the resume packages. The company offers a 30-day interview guarantee with certain packages. They also have lots of positive customer reviews on trusted platforms.

Not all resume packages offer phone contact with the writers, the interview guarantee, or the most experienced writers. You can pay an additional fee of $25 to add a phone call to your order with lower packages.

4.9/5 based on 1,757 Trustpilot reviews 4.9/5 based on 906 Shopper Approved reviews 4.3/5 based on 64 Sitejabber reviews 2/5 based on 8 BBB reviews

3 – 5 business days (can expedite to 48 hours)

[email protected]

Inspire Careers

Inspire Careers is run by Cathy Lanzalaco, a Certified Professional Resume Writer (CPRW). She has won a Recognizing Outstanding Achievement in Resumes (ROAR) Award. Cathy was a registered nurse and also has a background in Healthcare HR leadership.

You can see quite a few resume samples on the website. The company offers a variety of services that can help you take your career to the next level. Also, you will get to work with Cathy herself.

The resume service is a bit more costly than other services on our list. Also, they do not offer any interview or satisfaction guarantees.

4.3/5 based on 10 Google reviews 5/5 based on 1 Yelp review 5/5 based on 1 Facebook review

$850 – $2,000+

(716) 481-7662 or [email protected]

Previous Years Winners

Resume writing winners (2023).

Find My Profession, ResumeZest, Nurse Resume Writing Service, ReadyHire Medical Resumes, iHire Healthcare Administration, Joe Connor Career Marketing, TopStack Resume, Inspire Careers

Resume Writing Winners (2022)

Resume writing winners (2021).

Find My Profession, ResumeZest, Nurse Resume Writing Service, ReadyHire Medical Resumes, iHire Healthcare Administration, Joe Connor Career Marketing, TopStack Resume

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Medical Writer Resume Examples: Proven To Get You Hired In 2024

Jump to a template:

• Medical Writer
• Healthcare Content Writer
• Medical Communications Specialist
• Medical Content Strategist
• Medical Science Writer

Get advice on each section of your resume:

Jump to a resource:

• Medical Writer Resume Tips

Medical Writer Resume Template

Download in google doc, word or pdf for free. designed to pass resume screening software in 2022., medical writer resume sample.

As a Medical Writer, you'll be bridging the gap between complex medical and scientific information and your target audience, working on various projects like academic papers, promotional materials, and educational content. This field is evolving rapidly, so it's essential to showcase your knowledge of the latest industry trends and adaptability to new formats on your resume. Not only should you highlight your educational background and writing experience, but also demonstrate your ability to understand and communicate complex medical concepts and terminology in a clear, concise manner. In your resume, emphasize your expertise in areas like clinical research, regulatory submissions, or medical education, depending on the specific position you're applying for. It's crucial to tailor your resume to the needs and requirements of each organization, as some may prioritize candidates with experience in a particular therapeutic area or a background working with specific target audiences (e.g., physicians, patients, or payers).

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Recruiter Insight: Why this resume works in 2022

Tips to help you write your medical writer resume in 2024,    showcase your writing samples.

As a Medical Writer, it's important to include relevant writing samples in your resume or portfolio. This will give potential employers an idea of your writing style, attention to detail, and ability to convey complex information in a digestible format.

   Highlight your therapeutic area expertise

Employers often seek Medical Writers with specific expertise in one or more therapeutic areas. Make sure to emphasize any experience or knowledge you have in key therapeutic areas relevant to the job you're applying for, and try to quantify your experience if possible (e.g., number of projects or publications).

Medical writing is very specific and very technical. It could take the form of medical studies, training programs, literary reviews, brochures, etc. To be suited in this industry you need to have a medical background or a strong understanding of the field. This work may require in-depth research and specification. There is no room for error as the consequences of any misinformation could be deadly for the reader if acted upon. Recruiters will be looking to see your experience and qualifications in the medical field. Here is an example of a strong medical writer’s resume.

   Have a specialized portfolio.

If you have worked as a writer in other fields, make sure you create a specialized portfolio containing your strongest content from the medical field only.

   Use medical industry keywords.

Show recruiters that you are well versed in the medical field by using industry-standard keywords. Use words like ‘clinical trials’, ‘PubMed’, ‘RW medication, etc. It shows that you are knowledgeable in the field and may help you bypass resume filters recruiters may have put in place.

Healthcare Content Writer Resume Sample

Medical communications specialist resume sample, medical content strategist resume sample, medical science writer resume sample.

As a hiring manager who has recruited medical writers at companies like Pfizer, Novartis, and Johnson & Johnson, I've reviewed hundreds of resumes. The following tips will help your medical writer resume stand out and demonstrate the skills and experience that employers value most in this field.

Employers look for medical writers with deep knowledge in specific therapeutic areas. Emphasize your expertise in the areas most relevant to the position you're targeting, such as:

• Oncology: Wrote 15+ clinical study reports and manuscripts on breast cancer and lung cancer trials
• Cardiology: Developed patient education materials and slide decks on hypertension, heart failure, and anticoagulants
• Neurology: Created training modules on Alzheimer's disease, Parkinson's disease, and multiple sclerosis for sales reps

   Quantify your writing and project management experience

Use specific numbers to highlight the scope and impact of your work. Instead of generic statements, provide measurable details:

• Wrote various regulatory documents for clinical trials
• Managed multiple projects simultaneously

Quantify your achievements to paint a clearer picture of your capabilities:

• Authored 25+ clinical study protocols, reports, and summaries in the past 5 years
• Managed document timelines and budgets for 6 concurrent clinical trials, ensuring 100% on-time delivery

   Showcase your collaboration and communication skills

Medical writing requires close collaboration with cross-functional teams. Highlight examples of how you've worked effectively with others:

• Partnered with medical affairs, regulatory, and legal teams to develop and review scientific content
• Facilitated meetings with key opinion leaders to gather insights for advisory board materials
• Presented complex data to non-technical audiences, including sales reps and patients

Also, emphasize your communication skills in different formats:

• Wrote clear, concise, and scientifically accurate manuscripts, posters, and abstracts
• Developed engaging slide decks and speaker notes for medical conferences

   Include relevant certifications and professional development

Showcase your commitment to the medical writing field by listing relevant certifications, such as:

• American Medical Writers Association (AMWA) Medical Writing Certification
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society
• Drug Development Certificate from the University of California, San Diego

Also, highlight any professional development courses or workshops you've completed to stay current in the field, such as:

• AMWA workshops on writing clinical study protocols and investigator brochures
• DIA webinars on regulatory writing best practices and trends

   Tailor your resume to the specific job requirements

Customize your resume for each medical writing position to showcase your most relevant qualifications. For example:

• A generic resume summary: "Experienced medical writer with strong scientific background and attention to detail"

Instead, align your summary with the job description:

Clinical research medical writer with 7+ years of experience in oncology and infectious diseases. Skilled in writing protocols, CSRs, and manuscripts for Phase I-III trials. Collaborated with cross-functional teams to deliver high-quality documents on tight timelines.

Throughout your resume, emphasize the specific therapeutic areas, document types, and skills that match the job requirements.

   Demonstrate your impact on business goals

In addition to your writing skills, show how your work contributes to the company's objectives. Use examples like:

• Wrote 3 successful Investigational New Drug (IND) applications, enabling the company to advance pipeline candidates to clinical trials
• Developed product monographs and training materials that supported a successful product launch, resulting in $50M in first-year sales
• Created value dossiers and health economic models that helped secure formulary coverage for a key product at top pharmacy benefit managers

By tying your achievements to business goals, you demonstrate your value beyond just writing.

Writing Your Medical Writer Resume: Section By Section

  summary.

When applying for medical writer roles, your resume summary is an opportunity to quickly showcase your most relevant experience, skills, and qualifications. While a summary is optional, it can be particularly useful if you're a career changer or have a lot of experience to summarize. However, avoid using an objective statement, as it's outdated and focuses on your goals rather than what you can offer the employer.

When crafting your medical writer resume summary, focus on highlighting your key strengths, accomplishments, and industry expertise. Tailor your summary to the specific role and company you're targeting, and incorporate relevant keywords to help your resume pass applicant tracking systems (ATS).

To learn how to write an effective resume summary for your Medical Writer resume, or figure out if you need one, please read Medical Writer Resume Summary Examples , or Medical Writer Resume Objective Examples .

1. Highlight your medical writing expertise

When writing your medical writer resume summary, emphasize your specific expertise and knowledge in the field. Showcase your familiarity with medical terminology, scientific writing, and relevant therapeutic areas. For example:

Medical writer with 5+ years of experience creating clear, accurate, and compelling scientific content across various therapeutic areas, including oncology, cardiology, and neurology. Skilled in translating complex scientific information into easily understandable language for diverse audiences.

Avoid generic statements that could apply to any writing role, such as:

• Experienced writer with strong communication skills
• Detail-oriented professional with a passion for writing

2. Quantify your achievements

When possible, quantify your achievements in your medical writer resume summary to provide concrete evidence of your impact. This helps hiring managers better understand the scope and significance of your contributions. For instance:

• Authored 20+ clinical study reports, manuscripts, and abstracts, contributing to the successful approval of 3 novel therapies
• Collaborated with cross-functional teams to develop and implement a new SOPs, improving document quality and reducing revision time by 30%

Avoid using vague or subjective statements that don't demonstrate your tangible impact, such as:

• Wrote numerous medical documents
• Consistently produced high-quality work

  Experience

The work experience section is the backbone of your resume as a medical writer. It's where you showcase your relevant professional experience, key accomplishments, and the impact you've made in your previous roles. Let's break down the key steps to write an effective work experience section that will catch the attention of hiring managers and help you land your next medical writing job.

1. Use strong medical writing verbs

When describing your work experience, use strong action verbs that are relevant to medical writing. This helps paint a vivid picture of your skills and experience. Consider verbs such as:

• Authored clinical study reports and manuscripts
• Collaborated with cross-functional teams to develop scientific content
• Analyzed complex data sets to identify key insights
• Edited and proofread medical documents for accuracy and clarity

Avoid generic or weak verbs like "worked on" or "helped with" that don't effectively communicate your contributions.

2. Highlight your therapeutic area expertise

As a medical writer, your therapeutic area knowledge is crucial. Showcase your expertise by highlighting the specific therapeutic areas you've worked on in your previous roles. This helps demonstrate your depth of knowledge and ability to understand complex scientific concepts.

Here's an example of how to effectively showcase your therapeutic area expertise:

• Developed scientific content across various therapeutic areas, including oncology, cardiology, and neurology
• Authored 10+ clinical study reports in the areas of infectious diseases and vaccines

Contrast that with a less effective example:

• Wrote various documents for different therapeutic areas

3. Quantify your achievements with metrics

Whenever possible, use hard numbers and metrics to quantify your achievements and demonstrate your impact. This helps hiring managers understand the scope of your work and the value you've brought to previous employers.

Here are some examples of how to effectively use metrics:

• Authored 15+ clinical regulatory documents, contributing to the successful submission of 5 INDs and 2 NDAs
• Managed the development of 20+ scientific publications, resulting in 12 peer-reviewed articles in high-impact journals
• Streamlined the review process for medical content, reducing turnaround time by 30%

If you don't have access to specific metrics, you can still provide a sense of scope using general numbers, like in this example:

Led the development of multiple global advisory board meetings, managing all aspects from content development to logistics for events with 25+ key opinion leaders

4. Showcase your career growth

Hiring managers love to see candidates who have progressively taken on more responsibility and grown in their careers. If you've been promoted or taken on leadership roles, make sure to highlight that in your work experience section.

Here's an example of how to showcase your career growth:

Senior Medical Writer, ABC Pharma (2018-Present) - Managed a team of 5 medical writers, overseeing the development of scientific content across multiple product lines - Served as the lead medical writer on 3 successful regulatory submissions Medical Writer, ABC Pharma (2016-2018) - Authored clinical study reports, manuscripts, and other scientific documents under the guidance of senior writers - Collaborated with cross-functional teams to ensure timely delivery of high-quality deliverables

Notice how the more recent role showcases increased responsibilities and leadership experience compared to the earlier role.

When highlighting your career growth, focus on the key achievements and responsibilities that illustrate your progression. Be selective about the details you include, especially for older roles. You can leave off less relevant experiences if you have an extensive work history.

  Education

The education section of your medical writer resume should be concise and relevant to the job you're applying for. It's important to highlight your academic achievements and any specialized training or certifications you have earned. Here are some tips to help you craft a strong education section:

1. List your highest degree first

Start with your most recent and relevant degree, such as a PhD or Master's in a scientific field. Include the name of the institution, the degree earned, and the year of graduation.

For example:

PhD in Biochemistry, University of California, Los Angeles, 2018 Master of Science in Biology, Stanford University, 2015

If you have a bachelor's degree or lower, you can still list it, but keep it brief:

Bachelor of Science in Chemistry, University of Michigan, 2012

2. Include relevant coursework and research

If you are a recent graduate or have taken courses directly related to medical writing, you can list them under your degree. This shows employers that you have specific knowledge and skills.

Relevant coursework might include:

• Scientific Writing
• Pharmacology
• Clinical Research Methods

You can also mention any research projects, publications, or presentations:

Thesis: "The Role of microRNAs in Cancer Metastasis" Co-authored paper published in Journal of Molecular Biology

3. Highlight medical writing certifications

If you have earned any certifications related to medical writing, such as the Medical Writing Certification (MWC) from the American Medical Writers Association, definitely include them in your education section.

Medical Writing Certification (MWC), American Medical Writers Association, 2020

Other relevant certifications might include:

• Regulatory Affairs Certification (RAC)
• Clinical Research Associate (CRA) Certification

4. Keep it brief for senior-level positions

If you are a senior-level medical writer with many years of experience, your education section should be concise. Employers will be more interested in your professional accomplishments.

PhD in Pharmacology, University of Pennsylvania Master of Science in Biochemistry, Duke University

Contrast this with an example of what not to do:

PhD in Pharmacology, University of Pennsylvania, 1992-1998 Dissertation: "The Pharmacokinetics of Novel Drug Delivery Systems" Master of Science in Biochemistry, Duke University, 1990-1992 Bachelor of Science in Biology, University of Virginia, 1986-1990 Relevant Coursework: Organic Chemistry, Genetics, Cell Biology

The bad example is too lengthy and includes unnecessary details for a senior candidate.

  Skills

The skills section of your resume is a critical component that showcases your qualifications and expertise to potential employers. As a medical writer, it's essential to highlight your relevant skills and knowledge to stand out in a competitive job market. In this section, we'll provide tips and examples to help you craft a compelling skills section that effectively communicates your value to hiring managers.

When listing your skills, focus on those that are directly relevant to medical writing. This may include:

• Scientific writing
• Clinical trial documentation
• Regulatory writing
• Medical terminology
• Research and data analysis

By emphasizing your medical writing-specific skills, you demonstrate your expertise and suitability for the role. Avoid including generic skills that could apply to any job, such as 'Microsoft Office' or 'Communication.'

Skills Scientific writing Clinical trial documentation Regulatory writing (IND, NDA, BLA) Medical terminology Research and data analysis

To ensure your skills section is tailored to the job, carefully review the job description and incorporate relevant keywords and phrases. This not only showcases your fit for the role but also helps your resume pass through Applicant Tracking Systems (ATS) that screen for specific keywords.

2. Categorize your skills for clarity

Organizing your skills into categories can make your skills section more readable and impactful. Consider grouping your skills into categories such as:

• Writing : Scientific writing, Medical writing, Regulatory writing
• Research : Literature review, Data analysis, Clinical trial design
• Tools : Adobe Acrobat, EndNote, Microsoft Office

By categorizing your skills, you make it easier for hiring managers to quickly identify your key strengths and how they align with the requirements of the medical writer position.

Skills Writing Research Analysis Adobe Microsoft Office

In the example above, the skills are too broad and lack context. Instead, provide specific skills within each category:

Skills Writing : Scientific manuscripts, Clinical study reports, Regulatory documents Research : Literature review, Data analysis, Clinical trial design Tools : Adobe Acrobat, EndNote, Microsoft Office

When categorizing your skills, prioritize the most relevant and impressive skills first within each category. This ensures that hiring managers see your key qualifications even if they only scan your resume briefly. For an expert review of your skills section and feedback on 30+ key criteria, consider using a tool like Score My Resume by Resume Worded.

3. Demonstrate proficiency levels

In some cases, it may be beneficial to indicate your level of proficiency for certain skills. This can help hiring managers gauge your expertise and determine if you're a good fit for the role. For example:

Skills Scientific writing (Expert) Clinical trial documentation (Advanced) Regulatory writing (Intermediate) Medical terminology (Expert) Research and data analysis (Advanced)

By providing proficiency levels, you give hiring managers a clearer picture of your strengths and areas where you may need additional training or support. However, only include proficiency levels if you can back them up with concrete examples or certifications.

Be honest when indicating your proficiency levels. Overestimating your skills may backfire if you're asked to demonstrate them during the interview process or on the job. If you're unsure about your proficiency level, err on the side of caution and choose a lower level or omit the proficiency indicator altogether.

4. Tailor your skills to the job description

One of the most effective ways to create a compelling skills section is to tailor it to the specific medical writer job you're applying for. Review the job description carefully and identify the key skills and qualifications the employer is looking for. Then, incorporate those skills into your skills section, using the same language and terminology as the job description.

For example, if the job description emphasizes experience with 'Clinical Study Reports (CSRs)' and 'Investigational New Drug (IND) applications,' make sure to include these specific terms in your skills section:

Skills Clinical Study Reports (CSRs) Investigational New Drug (IND) applications New Drug Application (NDA) writing Biologic License Application (BLA) writing Good Clinical Practice (GCP)

By tailoring your skills section to the job description, you demonstrate that you have the specific qualifications the employer is looking for and increase your chances of passing through ATS filters.

To ensure your resume is optimized for a specific medical writer job, consider using a tool like Targeted Resume by Resume Worded. This tool analyzes your resume against the job description and provides personalized feedback on how to better align your skills and qualifications with the employer's requirements.

Skills For Medical Writer Resumes

Here are examples of popular skills from Medical Writer job descriptions that you can include on your resume.

• Online Journalism
• Content Management
• Social Media Marketing
• Translation
• Content Development
• Social Media
• Digital Marketing

Skills Word Cloud For Medical Writer Resumes

This word cloud highlights the important keywords that appear on Medical Writer job descriptions and resumes. The bigger the word, the more frequently it appears on job postings, and the more likely you should include it in your resume.

How to use these skills?

Similar resume templates, biomedical engineer.

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Use our free resume checker to get expert feedback on your resume. You will:

•  Get a resume score compared to other Medical Writer resumes in your industry.

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Medical Writer Resumes

• Template #1: Medical Writer
• Template #2: Medical Writer
• Template #3: Medical Writer
• Template #4: Healthcare Content Writer
• Template #5: Medical Communications Specialist
• Template #6: Medical Content Strategist
• Template #7: Medical Science Writer
• Skills for Medical Writer Resumes
• Free Medical Writer Resume Review
• Other Marketing Resumes
• Medical Writer Interview Guide
• Medical Writer Sample Cover Letters
• Alternative Careers to a Content Writer
• All Resumes
• Resume Action Verbs

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I had a clear uptick in responses after using your template. I got many compliments on it from senior hiring staff, and my resume scored way higher when I ran it through ATS resume scanners because it was more readable. Thank you!

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Healthcare & Medical Executive Resume Writers

We write resumes for physicians and medical industry professionals.

Why Choose Us For Your Healthcare Resume

Whether you're on the front line working with patients, conducting research that will lead to the next medical breakthrough, teaching future doctors, or working behind the scenes in hospital administration, we can help..

Our healthcare and physician resume writers have helped clients working in a broad spectrum of positions, leveraging a powerful combination of industry knowledge and writing expertise to craft top-notch resumes that drive results. We also partner with healthcare executive recruiters who trust us to prepare documents for their clients. As a result, we know exactly what it takes to best position you for success. With Resume Pilots, you can trust that you're in good hands:

• We're Fully Accredited:  We are a member of the Professional Association of Resume Writers and Career Coaches.
• Our Writers are Top-Quality: Our writers are among the best in the industry. They have studied in the Ivy League and other top-tier institutions and worked for respected corporations.
• You'll Receive One-on-One Support:  Our writing services include an hour-long consultation so we can get an in-depth understanding of your background and career goals.
• Service is Our Priority:  We'll work with you to make sure you're satisfied with your documents.

Our Previous Clients in Healthcare & Medicine

• President & CEO - Pharmaceutical Company
• Chief Scientific Officer - Pharmaceutical Company
• Senior Vice President, Research & Development - Biologics Company
• Director, Vector Platform Technologies - Genetic Therapy Company
• Associate Professor - Psychiatry - Top 100 Medical School
• Quality Medical Director - University Hospital
• PACU and ICU Staff Nurses - Area Hospitals
• Patient Care Coordinator - University Hospital
• Medical Coders - Insurance Companies & Hospitals
• Registered Nurses (RN), Certified Registered Nurse Anesthetists (CRNA), Family Nurse Practitioners (FNP), Nurse Practitioners (NP) - Private Practice and Military  

Resume Pilots is an executive resume writing and corporate outplacement firm that works with driven, successful clients at all stages of their careers. Our Founder and Managing Partner, Matt Glodz, studied business communication at Cornell University and worked in corporate for Fortune 500 companies. He observed what drove the decision making of recruiters and hiring managers firsthand, noting that qualified candidates were frequently denied interview opportunities due to poorly written documents. At Resume Pilots, Matt and his team leverage their solid business and writing backgrounds to craft resumes that give their clients the best chance of landing interviews.

Our Writing Services

Professional Resume Writing Service

Resume and Cover Letter Writing Service

Resume and LinkedIn Writing Service

Resume, Cover Letter, and LinkedIn Preparation Service

Testimonials.

Resume Pilots brought a fresh take on my resume, focusing on my actual impact and outcomes rather than the usual description of each role. This approach resonated with each of the three companies I applied for, with every one inviting me to interview. While it's an up-front investment, it absolutely pays for itself many times over!

ADAM • CHIEF TECHNOLOGY OFFICER • GLOBAL TECHNOLOGY COMPANY

Both the resume and LinkedIn profile were accurate, without spin or exaggeration, and both were flawlessly written and formatted. Most importantly, it was wonderful to work with Resume Pilots. They returned my emails and phone calls quickly and patiently provided clear guidance.

MIKE • CHIEF SCIENTIFIC OFFICER • PHARMACEUTICALS

The Resume Pilots team has developed a full-service program that helps you to highlight your key credentials and adapt them for those positions and organizations where you best fit. When you choose to work with Resume Pilots, you place yourself in good hands: coaches who are insightful, empathetic, and laser-focused. The return on your investment will be immeasurable.

PROFESSOR CRAIG SNOW • CORNELL UNIVERSITY

Great service from start to finish. Very professional but still retaining that personal touch that so many other professional services of this type either lack to begin with or unfortunately shed along the way. Provides exactly what is promised and then goes a little further. 

NICHOLAS • HEAD OF INVESTMENT BANKING • LEADING BANK

Interviews within days of using my resume! I felt really confident that my resume told the story of my career and had a great response rate of getting interviews very quickly after sending. The process was enjoyable and easy, and I would highly recommend Resume Pilots to anyone job searching or just needing to update their resume!

NINA • PRESIDENT • MARKETING AGENCY

The experience with Resume Pilots far exceeded my expectations! I previously used large resume writing companies where you are just a number and get 1 revision through an email. Resume Pilots took the time for an in-depth phone call to gather my information. I have already received 2 phone interviews in only 2 weeks. Success!

PAMELA • PROJECT MANAGER • INTERNATIONAL CPG COMPANY

Read more client testimonials on Trustpilot!

The 7 Best Healthcare Resume Writers in 2022

Are you looking for a healthcare resume writer but overwhelmed by the daunting number of options?

So were we. After extensive research, we’ve discovered the best healthcare resume writing services.

Our certified resume experts have reviewed hundreds of professional resume writers and identified the most important things to look for when choosing a healthcare resume service.

Overall Rating: How does the resume service compare to other services?

Resume Quality: Will you receive a unique, eye-catching, ATS-compatible resume?

Phone Consult: Is a one-on-one phone consultation with your writer included with your resume?

Draft Time: How quickly will the service deliver the first draft of your resume?

Resume Cost: How much will your professional resume cost?

Satisfaction Guarantee: Are there any guarantees included with your resume?

1 ResumeZest

Best overall resume service.

Who you work with: The ResumeZest team consists of Certified Professional Resume Writers (CPRWs) with backgrounds in HR, recruiting, and career coaching. Your writer is assigned based on your unique background and experience ensuring you work with someone familiar with your line of work.

Additional services: Cover letter writing, LinkedIn profile makeover, professional bios, thank you letters, and expedited delivery.

2 Find My Profession

Elite option for executives.

Who you work with: Find My Profession hires elite US-based Master Resume Writers with experience covering 85+ industries and professions. Whether you are a physician, lawyer, executive, or working for the federal government, they will assign you a seasoned writer with vast experience in your line of work.

Additional services: LinkedIn profile makeover, cover letter writing, expedited delivery, professional bios, career coaching, and professionally managed job search.

Master Resume Writer

Who you work with: iHireHealthCareAdministration is a dedicated job site for the healthcare industry that also offers resume writing services for healthcare professionals. They have TORI Award-winning resume writers. The team includes Certified Advanced Resume Writers (CARW) and Certified Master Resume Writers (CMRW).

Additional services: Cover letter writing, job portal, and outplacement.

4 Resume Target

Resume distribution service.

Who you work with: Resume Target has been serving all industries and career levels for over 15 years with a 98% interview success rate. They have a team of professional healthcare resume writers. Their senior leadership holds over 40 years of experience in executive recruiting for Fortune 500 companies. 

Additional services: Resume distribution, LinkedIn profile makeover, expedited delivery, interview coaching, and webinars.

5 Nurse Resume Writing Service

Close-knit team of writers.

Who you work with: Nurse Resume Writing Service is run by Rosa Elizabeth Vargas. Rosa is a Certified Master Resume Writer (CMRW) with over 15 years of experience in healthcare resume writing. She is also a multiple TORI Award-winning writer. She has a background in nursing. She has a team of two certified assistant writers and a professional proofreader.

Additional services: Downloadable eBooks and resume and interview coaching.

Who you work with: ResuMeds is built by a group of healthcare professionals for healthcare professionals. They serve both medical and healthcare staff. Their writers understand medical jargon and skills, so you don’t need to worry that your resume will be outdated and generic. Also, the writers undergo rigorous training regularly. 

Additional services: Cover letter, LinkedIn profile, letter of intent, personal statement, and professional bio writing.

7 ReadyHire Medical Resumes

Who you work with: ReadyHire Medical Resumes has over 25 years of experience in medical resume writing. The company is the medical resume writing division of A Better Resume Service. The team at ReadyHire Medical Resumes are all senior writers with experience in healthcare resume writing. 

Additional services: None

Ready to Rewrite Your Resume?

Physician Resume Writing Service

Whether you’re ready to drive improvements to patient care, healthcare quality, and practice operations for a new organization, a well-written resume is vital for a Physician’s job search. However, when you have a wealth of experience and achievements, it’s difficult to know where to start with your resume. Our expert writers are here to help you!

Transform my resume

Reviewed by the community. Trusted by professionals.

based on 13,172 reviews on

based on 13,172 reviews

Resume updating and rewriting

The update and rewrite of my resume was well done. They listened to my input and organized it around my interest and to the interest of my preferred market. I also used the service to update my linkedIn profile to ensure consistency.

Danita was excellent

Danita was excellent. My Cover Letter, Resume, and Thank You Letter were well done. My LinkedIn makeover was incredible.

From Doer to Achiever

My writer turned my resume from sounding/looking like a desperate person hoping to land a job to a mature professional with valuable contributions to offer. I chose the resume+Linkedin option and am blown away by my "online makeover." Far and above all my expectations

Muoki Musau

I got hired shortly after my resume was created

I got hired shortly after my resume was completed. I feel like having the professional level of resume and cover letter that my Top Resume writer created gave me a little boost of confidence that I needed.

My resume writer took the time to…

My resume writer took the time to gather my work experience and explained the approach to writing a descriptive resume. The video clip allowed me to understand how to effectively update my resume using the same approach and therefore gain confidence in showcasing my qualifications, work experience, and skills sets.

Thanks Sam at TopResume!

After working with TopResume, my documents were ready to share with all the professional outlets. TopResume was responsive, professional, knowledgeable, and friendly. I didn’t realize my professional documents needed so much work. I would recommend to anyone whether actively looking for a job or just keeping options open. Thanks TopResume for pairing me up with Sam!

George did an excellent job making my…

George did an excellent job making my resume look as good as I do! I may have spent a long number of years working, but I do not have any confidence, especially as I am looking to change the direction of my career. Thank you for helping me out with this as it was very difficult for me to do on my own!

I am very pleased with the final…

I am very pleased with the final product "Abe M." developed. The improved resume helped me get past the first round of screening with several employers; I also received unsolicited recruiter inquiries, which I had not received before. The best part of my new resume is that it used my original skills, key achievements, and experience, but the wording was more concise, lively, and highlighted my strengths much better than I had done on my own.

Faster than expected, interviewing for 3 positions already.

The process was much faster than I'd expected. Jessika was diligent in returning my messages quickly so we could finish as soon as possible in order to start sending the resume out. I was very pleased with the aesthetics improvement as well as the general cleaning up of my resume.

Detailed and good

They provided me many useful information, from how a big company sorting through thousand of CV and pick the most suitable to why my CV short sell me. Before, I’ve failed many application, more than half never passed the CV round. Now, just understand why, I’ve could already adjusted my CV accordingly to appear better in the employer.

I took the feedback I got from the free…

I took the feedback I got from the free assessment and revised my resume. I did not end up using the survive further though. The feedback was the nicest and most constructive way of telling me my resume is terrible both aesthetically and at selling me. They gave examples and details that helped me redo it and now I am getting more calls after sending applications.

Why TopResume is best suited to write your Physician resume

As the world’s largest resume writing service, TopResume has written thousands of resumes that have enabled customers to find success as a Physician. We know how to effectively market your skills, and we will collaborate with you to showcase your experience and qualifications. Whether you excel at treating patients or leading practice operations, we know what’s needed to make your resume pop. You already know how difficult it is to stand out in a crowded marketplace, so we’re here to make sure you get noticed.

Who are the TopResume writers?

Senior Resume Writer

4+ years of experience, bachelor of arts in humanities and classical studies.

Billie is a passionate writer whose mission is to write impactful resumes to support career growth, evolution, and transition targets. Billie’s love of the written word spans her entire life, and she enjoys utilizing that passion to empower successful career transitions.

10+ years of experience

Master of arts in english.

Traci has a Master of Arts in English and has been writing since middle school. After spending several years in marketing, she used her writing skills and corporate knowledge to help job seekers put their best foot forward and achieve their career goals.

15+ Years of Experience

Bachelor of arts in english and business writing.

Jeremy has helped 6K+ clients gain the confidence to apply for and get their dream jobs. His educational background in English and business writing and dedication to supporting clients’ needs inspire him to deliver top-tier career support.

What you’ll get

When you order with TopResume, we’ll ask you about your career goals and preferences. Ideally, you will send us a few job postings you want to target. That way, you can be sure you’re getting a resume tailored for your needs. We might emphasize your expertise in developing a rapport with patients, or we could highlight your ability to perform certain procedures or surgeries. It all depends on your job search needs.

How we ensure your Physician resume will help you reach your job search goals

We highlight the most important details

To secure a role as a Physician, you need to present a diverse skill set. From diagnosing and treating a patient’s condition to collaborating with multidisciplinary healthcare teams, you are a vision-driven leader with a relentless focus on positive patient outcomes. We’ll make sure this comes through in your resume by achieving a perfect balance between your commitment to your patient care and medical expertise.

We’ll make your medical specialization and leadership skills a priority

We know that there’s more to excelling in a Physician position than caring for patients. That’s why we’ll complement your leadership skills with an emphasis on your professional accomplishments and medical specialization, along with your ability to stay current with the latest medical advancements and research.

We tailor your elevator pitch

Your resume profile is your elevator pitch. We’ll make sure that the first few profile sentences have a big impact. Whether your expertise lies in pediatrics, cardiology, geriatrics, obstetrics, or somewhere else entirely, we’ll find the right keywords and emphasize key career highlights to make sure a recruiter sits up and takes notice.

Have some more questions?

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"Thank you so much for all of your excellent work! I am so pleased with my CV. I will recommend you to anyone in need of a great writer."

"Wow!!! Is that even me? Looks so awesome! Thank you again."

"The first resume I mailed helped me get the position I really wanted. The hiring administrator told me that my resume was the "best he'd ever seen", and I was one of 4 candidates out of 450 resumes that was selected for an interview. Thanks so much!"

You can speak to an experienced resume writer now by calling 1-800-730-3244

With more than 25 years of experience in medical resume writing, you require a firm that has weathered the changes, growth and difficulty your career has.

We are ReadyHire Medical Resumes, the premiere medical resume writing and career support firm with more than 25 years of experience in working with Directors, Administrators, Physicians, Nurses and Medical Technical staff. Our client list includes a broad range of managers, caregivers and employees from major hospitals and teaching institutions across the U.S.

As a professional service solely dedicated to executive resume writing, we will provide the high level of service, support and ease you expect, while proving the achievement-oriented document that you and your target employers require.

To get the position you desire, you need an expertly written resume that focuses on your core strengths and experiences. Don't be fooled by sites offering simple resume templates. Each resume we create is as unique as the individual it represents. A resume is something most people only write a handful of times in their life, so they are not going to be an expert in it. Trust our experienced resume writers to create the perfect resume geared towards your career goals.

Our process begins with an initial consultation to determine goals, targets and set a strategy, while also outlining additional collateral your specific job search will require. We gather the information directly from you in a telephone interview, write, edit, design and publish the document and collaborate directly with you throughout the proofing cycle to ensure accuracy.

At ReadyHire Medical Resumes, we understand your constraints, and we have been providing thousands of individuals with the marketing materials they need to further their career for more than 25 years. We have created a firm with dedicated Senior Executive Resume Writers to ensure you receive the highest service and quality of executive resume for a global or domestic job search. You will work with your Senior Writer throughout the process to ensure the highest level of success through understanding your situation, career goals, obstacles and accomplishments. Your writer will serve as a coach, motivator and counsel to marketing your background both via the resume and job search collateral, as well as in interview preparation and coaching, LinkedIn branding, outplacement and headhunter management and preparing you for future career progression.

Although the development of the resume, including creating strategy, information gathering and writing and editing is complex, we will simplify the process for you to minimize your time required for the process and maximize the results of the document. The cycle for full resume development will normally take a few days, yet expedited and next day service is available should you require it.

Call us at 1-800-730-3244 to speak to a helpful, professional resume writer.

The Right Diagnosis for Your Medical Resume

Emergency care package.

• Primary Care Package + Cover Letter

Primary Care Package

• Keyword-enriched Resume
• Initial Draft in 3 Business Days
• Final copy in Word and PDF File
• Unlimited Revisions
• Filed in our Medical Resume Records

Intensive Care Package

• Primary Care Package + Cover Letter & LinkedIn

Still have questions in mind?

Refer to our Medical Resume FAQs.

Get your Healthcare or Medical Resume

In 4 easy steps.

It’s time to define the procedure on how to kick-start your job search. Maneuver toward your target job in four easy steps!

Resume Services Selection

Choose the package that best fits your needs.

Resume Checkup

Complete Resume Diagnosis

Your Prescription

Client recommendations.

Ava did a great job on my resume! She wrote it flawlessly that I’m confident I’ll get a lot of job interviews soon. Without a doubt, you’re truly the best choice for healthcare professionals like me!

I purchased a resume and added just a few dollars to get a cover letter and a LinkedIn profile. Everything was worth every penny! Johnlei is very responsive to my concerns. After a few days, he sent me my resume, cv, and LinkedIn profile copies! It was nice working with him.

I really enjoyed working with Katerina. I like how she turned small pieces of info into a great piece of work! She’s an expert writer and I can’t wait to share my job search stories with her!

Hi Resumeds, especially to Freya! Just wanted to say thanks for the great job you did. I have tried other resume writing companies before, but you guys did the work so well. Sure, I’ll get your service again in the future.

What a fabulous job! Thanks, Lucy, I still can’t believe what you did on my paper. I’ll recommend your company to friends who are looking for CV writers. You truly played a huge part in helping me reach my career goal.

Harriet, you’re really an expert. My friends were so impressed with my CV that I referred your company to them. I’m now excited with my job search, so thanks a lot for a job well done!

Let Healthcare Success Happen to You

Resume services, resume examples.

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Medical Writer resume example

You can make even the most complex medical topics accessible through your writing, so why does creating a resume feel so tough?

The good news is, if you’re looking for your next medical writing role, we can help.

In the guide below, we’ll share all our top writing tips, along with a medical writer resume example to help you overcome your writer’s block.

Guide contents

Resume templates 

Medical Writer Resume Example

This Medical Writer resume example gives you a good idea of how a good Medical Writer resume should look and read.

The information is presented professionally, and the content is well structured to ensure that time-strapped recruiters and hiring managers can find the important skills and knowledge quickly.

Refer to this example as you write your own resume.

Medical Writer resume layout and formatting

If you want to get noticed in the job market, you have to pay attention to the format and layout of your resume.

Essentially your resume needs to look highly polished, and provide hiring managers with an easy reading experience.

Use these resume formatting tips to get a head start on this.

How to format your resume

• Length: Recruiters often see hundreds of resumes per day – so keep yours under 2 pages in length, if you want to ensure it gets read in full.
• Font & text : Nobody likes to read huge unbroken paragraphs of text – and recruiters are no different. Break your resume text up with bullet points and use a clear simple font.
• Design & layout: Go with a resume design that looks good, but also allows for easy reading and navigation for employers. Ensure the page is clearly split up into sections by adding large font headings and dividing borders. Keep the color scheme simple and don’t overcrowd the page.
• Photos: You are not obliged to add a photo to your resume in the USA, but it can be a nice way of adding some life to the document.

Quick tip: Achieving a professional look for your resume can be difficult and time-consuming. If you want to create an attractive resume quickly, try our quick-and-easy Resume Builder and use one of their eye-catching resume templates.

Resume layout

Include the following sections when you write your resume .

• Name and contact details – Make it easy for employers to contact you, by putting these at the top.
• Resume summary – An intro paragraph sitting at the top of your resume, summarizing the reasons why you should be hired.
• Skills section – A short snappy list of your most important skills, that can be quickly digested
• Work experience – Reverse chronological list of your previous jobs – voluntary work and college placements can be included if you have no paid experience.
• Education – List your qualifications and professional training.
• Additional info – An optional section for things like hobbies and interests.

Here’s what you should include in each section of your resume.

Resume Contact Details

Add your name and contact details to the very top of your resume, making it easy for recruiters to get in touch

• Name and profession title
• Cell phone number – or another number you can answer quickly
• Location – Add your local area such as San Diego or New York – not your full address as that will take up too much space.
• Email address – Use your name or close variation – no nicknames from high school.

You can add a link to your LinkedIn profile if you have one – you do not need to include personal details like date of birth or marital status.

Medical Writer Resume Summary

Your resume summary is like your introduction to the recruiter or hiring manager – it should grab their attention and leave them eager to read more about you.

Achieve this by writing a snappy overview of your skills, knowledge and what value you can bring to an employer.

3 tips for creating a resume summary that will get noticed:

• Keep it concise: Aim for a short punchy paragraph of 4-7 lines. This is just enough info to showcase why you’d make the perfect hire, without going into excessive detail and overwhelming busy recruiters at such an early stage in the resume.
• Tailor to target jobs: Tailor your resume to your target jobs by studying the job description and adding as many matching skills as you can.
• Don’t use cliches: Recruiters always see cringey cliches like “ hardworking guru who works well in a team or individually ” – they don’t mean much to anyone, so focus your summary on tangible skills and experience.

Example resume summary for Medical Writer

What info to include in your medical writer resume summary.

• Summary of experience: What kind of companies have you worked for in the past? And which jobs have you carried out?
• Relevant skills: Highlight your skills which are most relevant to Medical Writer jobs, to ensure that recruiters see your most in-demand skills as soon as they open your resume.
• Vital qualifications: Showcase your level of education with a quick mention of any qualifications that are essential for the Medical Writer roles you are applying to.

Quick tip: Choose from hundreds of pre-written summaries across all industries, and add one to your resume with one-click in our quick-and-easy Resume Builder . All written by recruitment experts and easily tailored to suit your unique skillset and style.

Core skills section

Next, you should create a bullet pointed list of your core skills, formatted into 2-3 columns.

Here, you should focus on including the most important skills or knowledge listed in the job advertisement.

This will instantly prove that you’re an ideal candidate, even if a recruiter only has time to briefly scan your resume.

Top skills for your Medical Writer resume

Medical Communications – generating publications which are designed to stimulate awareness, discussion and procurement of new medical devices, drugs and treatments.

Editing and Proofreading – carefully checking for errors and appropriately amending copy before it is published or shared.

Scientific Content Standards – ensuring all publications confirm to the Scientific Content Standards.

Clinical Study Reports – writing complex reports which summarize clinical study objectives and results, including safety findings.

Regulatory Document Filings – submitting time-bound documents required for submission to relevant regulatory authorities across jurisdictions.

Quick tip: Our quick-and-easy Resume Builder contains thousands of in-demand skills for every profession that can be added to your resume in seconds – saving you time and greatly improving your chances of landing job interviews and getting hired.

Resume work experience section

Once you’ve hooked the hiring manager with your summary, you can really blow them away with you work experience.

List your previous jobs from newest to oldest to show the impact you made at each organization.

If you have years of experience, you can leave out some of the older jobs, and if you have little/no experience, you can bulk this section up with voluntary work and college placements.

Structuring your job descriptions

Resume job descriptions contain lots of information, so its crucial to structure them well.

Use the structure below to ensure hiring managers can consume the information easily.

Job outline

Each role description should begin with a qucik summary of the job and company, along with how the job fits into the strucuture of the organization.

Key responsibilities

Then delve into the detail of your job by listing out easy-to-read bullet points which show how you apply your skills in the workplace.

Tailor these bullet points to focus on the skills and knowledge that are required in the jobs you are applying for.

Key achievements

Finish each role by highlighting some impressive achievements you made whilst in the role.

Anything that benefited the employer can be included from making financial savings, to winning new customers.

Quantify your achievements with facts and figures if you can, e.g. “reduced call wait time by 10%”

Example job for Medical Writer resume

Write accurate and clear documents for an award-winning global medical communications agency that works alongside 1K+ pharmaceutical and biotechnology companies on some of the most innovative global healthcare products from early development through to post-launch.

Key Responsibilities

• Interview doctors and other healthcare professionals about their experiences with various treatments, therapeutic, and surgical procedures, as well as clinical trials.
• Use scientific materials to translate medical research into easily understandable language patients use before undergoing surgery or treatment plans.
• Draft research stories using evidence-backed medical terms/references to assure information is credible.
• Add graphics to support texts/illustrate points, format content to ensure suitability for targeted audiences, and proofreading final drafts before publication.

Quick tip: Create impressive job descriptions easily in our quick-and-easy Resume Builder by adding pre-written job phrases for every industry and career stage.

Education section

Towards the bottom of your resume, add your education section.

Here you should list your professional qualifications and academic record, such as high school diplomas or college degrees.

If you have lots of work experience, you can keep this section brief (because recruiters will be more interested in your career. If you have little/no experience then you should bulk this section up with plenty of detail.

Additional information

The bottom of your resume is a place to add any “additional info”

Any other info that didn’t fall into any of the previous sections can be added here.

If you have hobbies that are related to your profession or any awards or publications – add them here.

Writing your Medical Writer resume

A winning Medical Writer resume should look great, read well, and sell your skillset to hiring managers.

If you follow the steps above, you should be able to bag yourself a top job in no time.

And don’t forget you can use our quick-and-easy Resume Builder if you want to save time and ensure your resume contains the very best content.

Good luck with your job search!

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Medical Writer Resume Samples

The guide to resume tailoring.

Guide the recruiter to the conclusion that you are the best candidate for the medical writer job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies, tailor your resume & cover letter with wording that best fits for each job you apply.

Create a Resume in Minutes with Professional Resume Templates

• Collaboration with management team to provide training to Medical Writers to ensure best working practices are maintained
• Develops and manages timelines for document development
• Provide constructive feedback to investigators to improve clarity, logic, and persuasiveness of grant proposals
• Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures) will be expected to perform the above functions
• Provide medical advice/expertise across many therapeutic areas (internally and externally) and quickly develop expertise in new therapeutic areas
• Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents
• Contribute to the development of frameworks, modules, templates, and general guidelines for IRCs, reviewer manuals, and imaging CRFs
• Provide scientific expertise to Business Development in the development of new business pitches and proposals
• You will assist Business Development team with the preparation of proposals and cost estimates for medical writing tasks
• To assist Senior Management to assess functional operations and plan for new procedures
• Communicates with and works effectively and productively with all authors on the development of scientific publications
• Ensures publications are developed in accordance with the established timelines
• Develop detailed timelines for document development in line with team and company goals and procedures
• Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks.
• Managing the business development and pricing projects for Medical Writing
• Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals
• Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve
• Serves as medical writing lead on more complex or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals
• Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). Coaches, mentors, and assists medical writers. Provides guidance to non-Abbott medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide
• Manage the review and approval process of clinical submissions documents, writing documents, generating consensus among reviewers, and facilitating discussions. Provide process, content, and submission document planning to the Clinical Submission, Clinical Satellite and Clinical Trial Teams. Advising on resource utilisation, efficiencies and timelines
• Assisting business development in securing new business
• Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Able to quickly acquire working knowledge regarding a variety of scientific/medical fields
• Basic knowledge of statistics, basic data interpretation and presentation skills
• Detail-oriented. Methodical. Goal-driven. Good judgment. Able to work with minimal supervision
• Good knowledge of regulatory documentation and drug development process
• Good interpersonal skills. Ability to work within a team
• Knowledge of medical terminology and basic statistical/clinical concepts
• Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance
• Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups
• Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability

15 Medical Writer resume templates

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• Have an eye for detail and be able to proofread and perform copy editing
• 0-3 years experience
• Masters in a scientific discipline preferred but can be substituted for experience related to scientific/medical writing
• BS degree in pharmacy or Doctoral level degree in a biomedical field 2 years experience in searching the biomedical literature 2 years experience in interpreting and using medical communication documents
• Knowledge of biomedical and pharmaceutical databases and vendors for accessing them
• Knowledge of Boolean logic/operators
• Problem-solving capabilities and excellent organizational skills
• Excellent grammatical and communication skills
• Writer skills, i.e. command of outlining, drafting, revising, and reviewing
• Basic editorial and proofreading skills
• Goal-driven
• Good judgment
• Able to work with minimal supervision
• Adaptable and flexible in nature
• Ability to work within a tea

Lead Medical Writer Resume Examples & Samples

• 85% - Leading the MW activities for assigned project(s) including writing key deliverables
• 15% - Leading or participating on non-project related initiatives
• Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required
• 5-7 years experience in clinical/pharmaceutical development with directly related medical writing experience
• Global regulatory submission experience preferred
• Ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team
• Ability, with some oversight, to lead the development, review, and approval of all clinical document types (ie, those typically developed by MW)
• Basic project management skills including understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups
• Ability to manage work timelines within assigned program(s)
• Strong written presentation skills and ability to present information to others
• Effective oral presentation skills (ie, ability to effectively lead a meeting and present issues)
• Ability to interact effectively with team members/leaders
• Ability to assess issues and develop potential solutions
• Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP)
• Working knowledge of the regulatory guidances regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs)
• Strong knowledge of MS Word (required), Excel (preferred), Project (preferred), Powerpoint (preferred), and Outlook
• Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types

Senior Medical Writer Resume Examples & Samples

• Requires a Bachelors/Masters degree in a scientific discipline or equivalent with a minimum of 2 to 5 years experience with a Bachelors, or 0 to 2 years with a Masters and demonstrated working knowledge of scientific principles
• Minimum 2 year experience in medical writing (3+ preferred) and publication strategy experience preferred
• Strong background in the basic sciences, with minimum 2-3 years experience in biotech/pharmaceutical
• Strong interpersonal, influence management, communication and organization skills
• Project management understanding, including decision analytical skills, budgeting and resource allocation and utilization
• Experience with information gathering and collection for research background
• Solid understanding of publication development activities, including gap analysis, planning and development strategies and tactics a plus
• With minimal support, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, Module 2 summary documents, and other IND/CTA or global regulatory submission documents
• Actively support and participate in clinical project team(s) as as an effective representative of Medical Writing
• Manage writing, editing, QC and publishing activities for assigned projects
• Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
• Ensure that medical writing activities are coordinated between the project team and management of the medical writing group
• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
• Global regulatory submission experience
• Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
• Knowledge of current regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
• Working knowledge of template use for document creation
• Ability to work with different template styles and types

Medical Writer, Phase, Remote Position Resume Examples & Samples

• Bachelor’s degree in a scientific discipline or licensed certification as an RN with 2+ years of experience
• Working knowledge of biomedical and statistical concepts
• Proficiency in Microsoft Office Suite

Medical Writer Contractor Resume Examples & Samples

• 2+ years of industry experience with a Masters' Degree in a Science discipline or 1+ year of industry experience with a Ph.D, Pharm.D, or equivalent in a Scientific discipline
• Previous training in the Biomedical Sciences, particularly in areas such as: Biology, Pharmacology, Chemistry and Biotechnology
• Solid understanding of Medical terminology

Senior / Lead Medical Writer Resume Examples & Samples

• 6+ years experience in the medical/regulatory writing field in the pharmaceutical/biotech industry or CRO environment
• Proficiency at authoring/editing CSRs, experience authoring/editing multiple other types of clinical regulatory documents (eg, study level, program level, health authority responses), and knowledge of multiple therapeutic areas, disease areas, and technical disciplines
• Thorough knowledge of the drug development process with an understanding of the strategy for regulatory submissions
• Knowledge and understanding of the principles of GXP, ICH, CTD and other global standards
• Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience
• Project work
• Monitor own adherence to budget and utilization rate
• Organizational
• Support team working principles within the business unit, account team and other departments and collaboration between business units by attending team and editorial meetings/tutorials
• Write and manage delivery of scientific content for a range of medical communications that meet client needs, internal quality standards and timelines
• Act as Lead Writer for one or more major accounts and provide the main point of contact on matters of scientific content for the client and KOLs
• Provide editorial quotes for costing purposes
• Advise Assistant Scientific Services Director and Scientific Services Director about resource requirements
• Recommend authors, publications and target journals
• Address journal peer review comments
• To review scientific content for range of medical communications, according to client needs, internal quality standards and agreed specifications, budgets and timeframes
• Monitor quality, style and accuracy and provide timely, consistent and constructive feedback
• Ensure that projects reflect a thorough understanding of clients’ objectives Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
• Contribute to revenue targets by ensuring that projects are progressed as soon as possible after confirmation
• Record and monitor actual time spent on a project against budgeted time, and complete timesheets in an accurate and timely manner
• Apply knowledge of the therapeutic use and strategic marketing of pharmaceuticals to account plans, strategic publication plans, strategic communication programs, proposals and pitches
• Participate fully in briefing and brainstorming meetings
• In conjunction with the Scientific Services Director and Assistant Scientific Services Director(s), help develop writers within an account team to achieve their full potential
• Coach and mentor junior writers as required
• Assist the Scientific Services Team Leader and Scientific Services Director in preparing and updating SOPs/training modules and in delivering editorial training in relevant therapy area/discipline
• Contribute to or conduct (as appropriate) performance and learning & development reviews and develop and monitor progress of objectives with direct reports
• Assist the Scientific Services Team Leader and Scientific Services Director in recruitment by interviewing candidates if required
• Support team working principles within Medical Communications, account team and other departments and collaboration between business units by attending team and editorial meetings/tutorials
• An excellent understanding of the pharmaceutical industry and the drug development process
• Experience in data handling and analysis
• Excellent writing, editing, and organizational skills
• Proficiency with Word, PowerPoint and other Microsoft packages
• Ability to manage multiple writing projects at one time
• Ability to present clearly and confidently to the highest level of customer
• 5+ years of experience as Medical Writer
• Experience with preparation of clinical documents (e.g. Clinical Trial Reports (Phase I - IV) and associated appendices, Investigator's Brochures, clinical sections of IND/IMPD/NDA/MAA/CTD
• Experience with preparation of Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, Clinical Expert Statements, Risk Management Plan)
• Working knowledge of regulatory guidance (such as ICH guidelines, EMEA requirements and FDA guidelines)
• Proficiency in using Documentum or other document management systems
• PhD in Science or Master's in Science depending on experience
• Experience with Common Computer Software
• 2-3 years of experience as a Medical Writer
• Resolve content-related queries from the client
• Participate in brainstorming new product lines or solutions that meet client needs
• Contribute to process improvements related to creation and maintenance of projects
• Advise Commercial and Editorial Services Directors about resource requirements
• Minimum of 5 years’ writing and editorial experience
• Experience in medical communication, tactical medical education, or training required; proven creativity preferred (eg, journalism, writing for a lay audience)
• Experience in oncology, endocrinology/diabetes, neurology, and immunology/infectious diseases is an advantage
• Superior language and communication skills
• Abilitiy to translate complex scientfic materials into various formats efficiently
• Customer focus, Teamwork, Innovation, Communication, Business awareness
• Ability to work independently with minimal supervision and also collaboratively with a team
• Understanding of the healthcare industry
• 3+ years of Medical Writing experience in the Pharmaceutical / Biotechnology industry or CRO environment
• Experience or background in working within the Pharmaceutical industry
• Awareness of Compliance issues and guidelines around Medical Education and Publications
• Strong Medical Writing / Copyediting skills
• Microsoft Office / Suite proficient
• Advanced Degree in Life or Health Sciences
• Knowledge of the Drug Development process
• Relevant Therapeutic background
• Clinical experience
• Performs macroediting of documents for organization, content, structure, and tone, and to ensure documents are consistent, and microediting of documents for punctuation, grammar, sentences, paragraphs, and writing styles
• Coordinates the review, revision, quality control, quality assurance, electronic publishing, and approval of documents
• Performs other projects and duties as required/assigned
• Advise Associate Scientific Services Director and Scientific Services Director about resource requirements
• Review scientific content for range of medical communications, according to client needs, internal quality standards and agreed specifications, budgets and timeframes
• Ensure that projects reflect a thorough understanding of clients’ objectives
• Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
• ​Coach and mentor junior writers as required
• Any other duties as requested by manager
• 2+ years of Medical / Managed Markets writing experience
• Knowledge and experience with Managed Markets solutions, Healthcare landscape and Payer / Managed Markets terminology
• Exceptional creative and writing abilities
• Degree in Nursing or PharmD

Senior Medical Writer / Editor Resume Examples & Samples

• Develop technical summaries for drugs under investigation (for healthcare professionals and consumers)
• Monitor scientific conferences and journals to stay up-to-date on the latest HIV/AIDS information
• Write and edit consumer-based content for the AIDSinfo web site, including fact sheets, clinical trial summaries, drug summaries, and other consumer-based materials using highly technical medical references
• Use a content management system to post information on the web, and review all postings to assure they match in text, style, and formatting to their original source documents
• Maintain and perform quality-control checks on all written materials produced on the project
• Upon request, support writing and editing of proposals, contract deliverables, and other business development activities
• PharmD or advanced science degree required (e.g., biology, chemistry, biochemistry)
• 3 years medical writing experience
• Ability to read and summarize technial journal articles for a lay audience
• Proficiency in searching online scientific databases
• Proficiency in MS Office applications (Word, PowerPoint, Outlook, Excel)
• Degree in a health or life science (e.g., public health, health communications, nursing, biology, biochemistry)
• HIV/AIDS-related experience
• Experience writing for government
• With support from senior level writers and/or Medical Writing Group Lead, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, and other IND/CTA or global regulatory submission documents
• Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Manage writing, editing, QC and publishing activities for assigned projects under the guidance of Medical Writing Group Lead and/or senior level writers
• Contribute to statistical output plan concerning organization and table layout for a specific document
• Work with Medical Writing Group Lead and/or senior level writers to ensure that medical writing activities are coordinated between the project team and the medical writing group
• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 2 years of pharmaceutical industry or academic experience in the clinical/regulatory field preferred
• Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team
• Ability to adhere to regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
• Strong knowledge of MS Word, Excel, MS Project, PowerPoint, and Outlook
• Ability to prioritize multiple projects

Medical Writer, Research Consultant Resume Examples & Samples

• Advanced degree in Science or English
• Exposure to healthcare data
• Background in scientific research
• To provide strategic direction and manage tactical delivery of scientific content for a range of medical communications that meet client needs, internal quality standards and timelines
• Act as senior editorial lead for one or more accounts and provide the main point of contact on matters of scientific content for the client and KOLs
• Advise Senior and Scientific Services Directors about editorial resource requirements
• To review scientific content for a range of medical communications according to client needs, internal quality standards and agreed specifications, budgets and timeframes
• Provide full briefs to delegate editorial projects to Medical Writers and Associate Medical Writers to include scope, content, time to spend on project and deadlines
• Monitor quality, style and accuracy and provide timely, consistent and constructive feedback when reviewing
• Ensure that projects reflect a thorough understanding of clients’ marketing objectives and that scientific messages are supported appropriately
• Liaise with clients and Account Manager to agree specifications and check that client expectations are being met
• Liaise with Senior and Scientific Services Directors on junior writers’ training needs and provide coaching and mentoring as required
• Provide scientific expertise to Business Development Manager in the development of new business pitches and proposals
• Provide scientific input to complement Account Management in developing new opportunities within accounts
• Assist with delivering editorial training in relevant therapy area/discipline
• Assist Senior and Scientific Services Directors in review of test projects and/or recruitment by interviewing candidates, if required
• Support team working principles and collaboration within inScience Communications, the account team and other departments, by attending team and editorial meetings/tutorials
• Required: Master's degree in Biological Sciences or Medical Writing or equivalent interdisciplinary program
• Preferred: PhD Degree in Biological Sciences or equivalent interdisciplinary program
• Required: Five years of related experience in medical writing
• Preferred: Five years of related experience in medical research environment
• Having a thorough understanding of the biology of chronic kidney disease, therapeutics, and competitive scientific data
• Preparing or editing documents for submission to external clients
• Preparing or editing internal documents requiring robust scientific summaries
• Performing QC checks on documents
• Conducting literature searches, reviewing pertinent literature, and preparing summaries or abstracts, as required
• Supporting DCR activities at scientific congresses
• Preparing and delivering scientific presentations to project stakeholders and key opinion leaders
• Here is what you can expect when you join our Village
• Award-winning education and training across multiple career paths to help you reach your potential
• A comprehensive benefits package designed to enhance your health, your financial well-being, and your future
• Advanced degree in the life sciences or a related medical/scientific field with at least 2 years medical communications and/or postdoctoral experience
• Knowledge of publication guidelines and best practices
• Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses
• Solid skills in critically appraising scientific literature and conducting comprehensive searches
• Experience working independently with minimal supervision; ability to work remotely in a matrix environment
• Knowledge of pertinent software (eg, MS Office, EndNote, Adobe Illustrator, GraphPad Prism)
• Preferred Qualifications
• Previous medical communications experience in a biotechnology or pharmaceutical company
• Previous relevant nephrology experience
• Successful track record in publication planning and execution
• Superb written and verbal communication skills; experience in both scientific and business presentations and communications
• Ability to apply project management skills to advance multiple projects simultaneously
• Sound working knowledge of ethical, legal, and regulatory guidelines and requirements applicable to medical and scientific affairs activities
• Advanced Scientific Degree (MSc., Ph.D., Pharm. D) required. Bachelor's Degree will be considered with appropriate work experience
• 5+ years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
• Responsible for writing and editing documents including, but not limited to, investigator brochures, integrated clinical/statistical study reports, clinical protocols and amendments, Integrated Summaries of Safety (ISS) and Efficacy (ISE), annual reports/DSURs, manuscripts and posters
• Accurately and consistently presents key clinical messages in accordance with program goals and regulatory requirements
• Writes documents (both internal and external) to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and provide accurate data presentation and interpretation
• Ensures final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the international conference on harmonization (ICH)
• Assists in developing strategy for organizing and preparing clinical documents for regulatory health authority submissions
• Performs quality control review of medical writing documents
• Assists in the development of templates, style guidelines and SOPs for clinical documentation
• Current working knowledge of the Department of Health and Human Services (DHHS) regulations, International Conference on Harmonization/Good Clinical Practices (ICH/GCP), Food and Drug Administration (FDA), and Office of Human Research Protections guidelines
• Ability to write and edit clear, concise clinical documents compliant with FDA and ICH guidelines, as well as all practices and procedures related to medical writing
• Ability to write concise meeting summaries and/or meeting minutes and create action plans
• Ability to prioritize workload and submit high quality deliverables in a professional environment under tight deadlines
• Strong collaborative skills with ability to build relationships within multiple groups
• Must be detail-oriented and possess substantial organizational skills
• Produce high quality and timely communication materials (manuscripts, reports, abstracts)
• Must be able to work smoothly as an integrated component of various case teams and be able to manage multiple projects simultaneously
• Effectively edit, proofread, and format all client messaging deliverables as well as occasional internal documents such as training manuals
• Handle all aspects of submission and follow up with journal editors; manage projects to ensure that authors respect deadlines and respond to comments promptly and effectively
• Review, critique, and revise written summaries of analytical work prepared by consultant case teams
• Contribute a reader's perspective and constructive criticism to analytical team to optimize the quality of the written messaging
• Participate in the development of standard approaches to manuscript writing and content development
• Act as a resource to colleagues to help them improve their writing and data presentation skills in the development of tables, graphs and other material ultimately incorporated client messaging documents
• Excellent writing abilities. Must be able to write clearly and concisely, and to explain complex scientific information to the general public, as well as to scientific peers
• Familiarity with scientific manuscript writing and format. Must be able to understand and quickly synthesize economic and clinical information
• Familiarity with medical terminology and clinical trial design (theoretical knowledge is sufficient). Must be able to rapidly research various health-related research areas, absorb, and synthesize the information in short time frames
• Familiarity with some reference manager software (EndNote, Reference Manager, Mendeley, Citavi, etc.). Must be able to produce fully referenced content and to adapt easily to new technologies and methodologies
• Extensive experience with standard MS Office Suite software, including Word, PowerPoint and Excel. Advanced document design skills (e.g., style, page, and document design) preferred
• Excellent time and project management skills, as well as team working skills. Must be able to prioritize and meet overlapping deadlines, take ownership of task schedules, as well as work well with multiple teams on separate projects
• Work with investigators within the Department of Medicine to develop, write, and revise basic, translational, and clinical research grant proposals for NIH, foundations, and other appropriate funding agencies
• Advise investigators on best strategies to convey significance, impact, and innovation of their research plan
• Consult with investigators in responding to critiques for grant proposal resubmissions
• Work with investigators to develop other scientific and/or medical documentation, as appropriate
• Establish and maintain effective working relationships with investigators
• Assist with other duties associated with the Department of Medicine Research Office, as appropriate
• Excellent critical analysis skills
• Able to establish effective collaborations with faculty investigators in various disciplines
• Able to meet deadlines in a timely manner
• Able to organize multiple tasks with varying deadlines
• Experience in an institution of higher education or large hospital
• Experience working as an independent consultant or medical writer
• Experience with submission of both small and large NIH grant proposals, preferably in an institution of higher education

Technical / Medical Writer Resume Examples & Samples

• Work cross functionally with subject matter experts to create and review all documents authored within the R&D department
• Ensure high writing quality, readability and consistency across all documentation
• Create and enhance processes for: document preparation, training for document authors and document approvers, and measurement of performance of writing activities (cost of documents, timeliness of documents, quality of documents)
• Understand business objectives and prioritize work accordingly
• Support a culture of continuous process improvement
• Mentor staff and display a strong commitment to coaching and development to contribute to career development within the department
• Develop and maintain strong ties with all functional groups and geographic locations within the business unit
• Bachelor’s degree with 9+ years exp. OR Master’s degree with 7+ years exp. in life sciences, or related field; higher degree preferred
• 5+ years’ experience in technical writing in a regulated commercial setting (CRO/biotech industry), preferably medical devices/ IVD diagnostics
• Excellent knowledge of Microsoft Word and Excel
• Experience with document control process preferred
• Excellent writing, editing, organizational, teamwork, and verbal communication, and leadership skills are essential
• Experience and knowledge of documents pertaining to medical devices /molecular diagnostics assay development & statistical methods is required

Expert Medical Writer Resume Examples & Samples

• Participate in planning of analysis and data presentation for individual study reports or summary documents
• Act as project medical writer for complex submission programs
• Contribute to development of document templates and processes both within
• Excellent medical writing skills
• Expert data interpretation and presentation skills
• Good understanding of statistics
• Expert knowledge of regulatory requirements and clinical development
• Good leadership skills within cross-functional teams
• Good influencing and negotiating skills
• Ability to mentor other medical writers
• Experience of process improvement initiatives
• At least 3 years medical writing experience
• Good knowledge of statistics and data interpretation and presentation skills
• Very good knowledge of clinical documentation
• Good knowledge of regulatory requirements
• Good knowledge of drug development
• Writes and edits clinical documents sent for regulatory review or approval including: clinical plans, clinical study protocols and reports, integrated summaries, package insert text relating to clinical studies, responses to FDA and regulatory agency inquiries
• Provides significant scientific contribution in preparation of clinical documentation
• Represents medical writing in clinical project teams and/or core team meetings
• Supports clinical communication efforts including presentations, abstracts, manuscripts or ad hoc reports
• Researches and reviews medical and scientific literature
• Contributes in the development of clinical plans with the appropriate hypotheses, study designs, and methods
• Works with team members to ensure scientific integrity of data by assisting in the development of data collection/review/analysis materials (e.g., CRFs, statistical analysis plans)
• Provides scientific guidance to team members and reviews data to identify and investigate discrepant results or issues
• Integrates various sources of information into uniform language styles and analyzes documents for accuracy, consistency, relevancy, correctness of conclusions, alternate hypotheses, editorial corrections, and other issues for regulatory compliance
• Collates multiple reviewers’ comments, analyzes applicability, and edits documents to reviewers’ satisfaction
• Provides drafting and editing support as needed for protocol amendments, and continuing reviews
• Keeps abreast with current industry practices and regulatory requirements and guidelines pertaining to medical writing
• Produces high quality documents in accordance to regulatory standards, including but not limited to FDA and ICH guidelines, and GCP’s, as well as company SOP’s and templates
• BA or BS in Life Sciences with at least 9 years of medical writing experience, or MS degree with at least 6 years of medical writing experience, or PhD. with at least 4 years of medical writing experience
• Molecular diagnostics industry experience strongly preferred
• Scientific and clinical expertise strongly preferred
• Advanced scientific reading, writing, and editing skills
• Good understanding of clinical experimental methods, clinical study design, and statistical analysis
• Ability to interpret, analyze, and report statistical data from clinical studies to meet regulatory obligations, and for scientific publication or presentation
• Expertise in searching medical literature and databases for clinical and technical information
• Solid understanding of FDA regulations and ICH/GCP guidelines
• Excellent project/time management and organizational skills to handle multiple tasks and meet deadlines while delivering high quality work
• Ability to accurately interpret data and present complex information in a clear and concise written manner
• Proficient computer and word processing skills
• Bachelor’s degree/Nursing Degree required. Masters or PH.D preferred
• Bachelor’s degree plus 8 years relevant experience; or Masters degree plus 6 years relevant experience or PhD plus 2 years relevant experience
• Experience in the conduct of clinical research/medical communications required. Technical writing experience required
• Writing experience in medicine, science, business, and technology required
• Experience from a contract research organization, pharmaceutical or biotechnology firm preferred
• Must have in-depth knowledge of the research and writing process, FDA guidelines, regulatory guidelines, AMA style guidelines and other specialized medical writing knowledge
• Experience in medical writing of regulatory documents such as patient narratives, informed consent forms, experience papers, manuscripts preferred
• Must possess excellent interpersonal, written and oral communication skills, with demonstrated ability to communicate scientific information inside and outside the organization

Senior Prin Medical Writer Resume Examples & Samples

• Bachelors Degree with 10+ years of experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, or government sponsored clinical research. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable
• MS, MA, or MPH with 8+ years of experience or PharmD, PhD, DVM, or MD with 6+ years of experience
• BS or BA with 10+ years of experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, and government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable
• MS, MA, or MPH with 8+ years of experience or PharmD, PhD, DVM, or MD with 6+ years of experience supporting clinical research
• At least two years of study management experience preferred
• Experience in assessing medical evidence
• Experience in publication planning
• Project management skills and experience with related tools (Microsoft Project)
• Familiarity with ICMJE guidelines and Good Publication Practices
• Demonstrated ability to identify issues and implement solutions, including identifying and involving the appropriate decision makers
• Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to achieve objectives and milestones
• Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals

Prin Medical Writer Resume Examples & Samples

• Bachelors Degree with 7+ years of experience supporting clinical research (MS, MA, or MPH with 5+ years of experience or PharmD, PhD, DVM, or MD with 3+ years of experience). Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, or government sponsored clinical research. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable
• Experience in technical writing such as clinical study plans, clinical reports, scientific manuscripts, clinical evidence reports
• Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
• Willingness to accept challenging assignments and engage in relevant developmental activities
• Proficient knowledge of medical terminology
• Knowledge in the areas of neurology and/or psychiatry
• Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment

Prin Medical Writer / Clinical Evidence Spec Resume Examples & Samples

• Strong critical thinking and analytical skills
• Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
• Demonstrated ability to clearly and effectively communicate verbally and in writing
• 6+ years experience supporting industry-sponsored clinical research
• 2+yearssupporting medical/scientific publications
• Expert in scientific communication and writing skills
• Ability to interpret clinical data and understand biostatistics
• Expertise using EndNote, PowerPoint, WORD and Excel
• Strong knowledge of medical terminology and literature searching
• Significant work experience in publication development in the biotechnology industry or a specialty vendor. Specific experience with publications in cardiovascular disease and treatment
• Demonstrated ability to successfully interact with a variety of functions and levels within an organization

Principal Medical Writer Resume Examples & Samples

• Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US)
• Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects
• Serves as a department representative on project teams
• Communicates deliverables needed, writing process, and timelines to team members
• Converts relevant data and information into a form that meets clinical regulatory document requirements
• Ensures all clinical regulatory electronic document deliverables are processed and compiled in alignment with timelines
• Assesses resource needs as timelines progress, and communicates those needs to department management
• Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors. Ensures required documentation is obtained
• Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables
• Explains data in manner consistent with clinical regulatory requirements
• Confirms completeness of information to be presented. Challenges conclusions when necessary
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs
• Arranges and conducts review meetings with the team
• Independently resolves document content issues and questions arising during the writing process
• Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions
• Recommends, leads, and implements tactical process improvements
• Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with Regulatory on document strategies

Contract Medical Writer Resume Examples & Samples

• Oversee number accuracy against source documents and for consistency within given document and between associated documents (for example, making sure the details of a protocol align with the SAP and IB, or making sure the messaging and details in a briefing package align with the messaging and details in applicable protocols, study reports, IBs, other regulatory submission documents, etc.) per MW SOPs and internal procedures
• Familiarity with ICH, GCP guidelines and associated clinical development regulations such as the eCTD and submission readiness is required
• Expertise with Word and Adobe Acrobat is a must
• The successful candidate will be focused, methodical, and detail oriented, able to discriminate substantive or critical errors from minor ones, and will be able to communicate diplomatically and function as a collaborative team member
• Bachelor’s Degree in health science or other area; advanced degree preferred
• Nursing, pharmacy, or other clinical experience is preferred
• Experience with regulatory submissions presented to regulatory authorities
• 1-3 years of directly related work experience as a medical writer in a clinical research of drug development environment (pharmaceutical/biotech or CRO setting)
• Must be familiar with Common Technical Document (CTD) standards, and have experience working with standard document templates/styles to support electronic (eCTD) submissions
• Must be comfortable working in a demanding, fast-paced environment
• Must be comfortable responding to and managing change
• Must be proficient with Windows, Microsoft Word, Microsoft Excel, Adobe Acrobat, and Microsoft PowerPoint
• Must have excellent written and oral communication skills, keen attention to detail
• Must have the ability to manage day to day tasks while understanding and appreciating the overall strategic goals for the team/department/project/company
• Responsibilities may include but are not limited to
• In collaboration with other functional areas, contribute to regulatory submissions by authoring relevant sections of eCTDs (e.g., ISS, Summary of Clinical Safety)
• Analyze, interpret, and accurately present data in text, table, or figure format, as needed
• Assisting with responses to questions from regulatory authorities (e.g., MA and FDA)
• Reliance on instructions, templates, and pre-established guidelines will be expected to perform the above functions. The candidate must be able to work independently and efficiently with cross‑functional team members
• The ideal applicant would have training in the biomedical research sciences, particularly in areas such as biology, pharmacology, chemistry, and biotechnology
• The applicant would have previous experience leading and writing submission-level documents, including familiarity with eCTD format and associated guidance’s
• This position requires translating technical information from multiple sources (Statistical Analysis Plans, previous regulatory submissions, programmed data outputs) into summary documents suitable for an audience of regulatory authorities
• As a lead author, this person must work cross-functionally with appropriate teammates to create, coordinate review of, and edit through finalization required regulatory clinical summary documents
• The exercise of good judgment in the incorporation of review comments from multiple individuals will be needed
• The applicant must be able to prepare deliverables in accordance with pre-established timelines and specifications, systematically performing activities in a timely and accurate manner
• A commitment to accuracy of data presentation and ever improving the clarity of communication is essential
• This writer will also engage in the project management of document support activities by others (QC and publishing) to deliver high-quality submission-ready documents in accordance with the agreed timelines
• Advanced writing competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are expected

Director, Medical Writer Resume Examples & Samples

• Experience in multiple therapeutic areas, with prior experience in CNS preferred
• Experience in clinical study design and protocol development/writing
• Strong interpersonal, communication, and organizational skills; ability to work cross-functionally, collaborate, negotiate with and influence stakeholders at all levels of the organization
• Knowledge of regulatory guidelines related to clinical development and regulatory marketing applications
• Demonstrated project leadership/management skills
• Experience using computerized systems (PC-Windows and MS Word)
• Creating, modifying and finalizing Site Manuals or Imaging Guidelines, associated fillable forms, quick reference guides and labels
• Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries
• Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs
• Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
• Attending internal and external meetings relating to the Site Manuals, IQA/PQA Summaries, CRs/KPDs
• Running Scheduled Tasks for generating MedComm webpages
• Checking MedComm webpages for errors
• Performing Project Close-outs as they occur based on receipt of Study Closure forms
• Reviewing and updating Charter Training Slides as needed
• Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required
• Creating, modifying and finalizing Charters with Key Points Appendix (KPA), Process Documents, Procedures Documents, Methodology Reports, or other read-related study documents
• Creating, modifying and finalizing Clinical Data Transfer Plans (CDTPs)
• Creating, modifying and finalizing Read Rules documents
• Reviewing and modifying criteria-related Investigator Meeting slides
• Attending internal and external meetings relating to the Charter, CDTP, Read Rules, or required CRs
• Creating, modifying and finalizing Global Conventions and Glossary documents
• Reviewing applicable study start-up documents (i.e., Manuals and forms, KPDs if applicable) for accuracy, completion and consistency across all study documents
• Staying up-to-date on response criteria publications posted by Medical Communications
• Attending and participating in applicable company-sponsored training
• Ability to work in a group setting and independently; ability to adjust to changing priorities
• Excellent attention to detail and orientation toward meticulous work
• Ability to project and maintain a professional and positive attitude
• Organization and time management skills for managing multiple projects concurrentl
• 1+ years medical writing experience required
• In collaboration with other relevant line functions, prepare and give directions – as medical writing lead –
• Provide direction to team on document content and provide innovative solutions to cross-functional areas
• Identify resource issues and determine how to allocate resources to meet timelines
• In collaboration with medical writing and other functions, prepare internal guidelines for document
• Extensive experience writing all types of clinical & regulatory documents and with registration dossiers
• Assist in the preparation of regulatory submissions (BLAs), scientific manuscripts, abstracts, PowerPoint presentations, and posters as needed
• Assist in the development of SOPs for Clinical writing processes
• Provide additional support to the Medical Writing team and the Clinical team as needed
• Bachelor’s degree in a scientific discipline with at least 8 years of medical writing experience is required; an advance degree is preferred; equivalent combination of education and experience may be considered
• Excellent verbal and written communication skills, attention to detail, and project management skills
• Knowledge of regulatory guidelines (ICH/GCP) and understanding/compliance with appropriate conventions, proper grammar usage, and format requirements for regulatory documents and publications
• Demonstrated ability to work both independently and in team environments
• Attention to detail with an ability to detect errors and inconsistencies in various types of documents
• Oncology and Biopharmaceutical industry experience is strongly preferred
• Clinical research background or experience is preferred
• This is an office-based position; proven ability and experience working in-house is critical
• You will provide additional writing and editing services as required (e.g. for publications) as well as producing preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews and other documents needed for regulatory submissions
• Involved with quality control (review) of documents, you will interpret and summarise data from biostatistical summary tables and listings accurately, precisely and concisely into narrative text
• Liaising with internal groups such as Biostatistics, Data Management etc., you will obtain the necessary information to ensure the timely implementation of activities related to the production of reports
• You will interact directly with clients (with support where required) and keep the Senior Director of Medical Writing or designee informed of document status in relation to quality and timelines
• You will have a life science degree qualification (preferably at post-graduate level) or equivalent and have knowledge of the clinical trial process, gained preferably from previous experience as a medical writer
• A highly organised, self-motivated individual, you are able to plan/prioritise effectively and demonstrate expertise with grammar, syntax and format, with advanced word processing and related computer skills
• You are a keen problem-solver with excellent written and oral communication skills. You should also have strong interpersonal skills, which enable you to win the confidence and cooperation of colleagues
• Preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs and their supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements
• Be part of a clinical NDA sub team and provide strategic input into modules 2 and 5 of a NDA
• Consolidation and evaluation of teammates’ review comments to determine needed revisions
• Reviewing statistical analysis plans and accompanying table and listing shells for the evaluation and presentation of clinical trial data
• Quality-checking documents for agreement between in-text information and the source data
• Editorial review of documents for grammar, punctuation, and submission-compliant formatting
• Provide overall medical writing support for ongoing programs (protocols, IBs, etc)
• Registered Nurse, Bachelor's degree or higher in Life Sciences
• Training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication preferred
• BS, or RN with 12 years’ experience, MS with 8-10 years’ experience or Ph.D, Pharm.D, or equivalent with 5 years’ experience in medical writing
• Excellent and current knowledge of GCP, ICH and FDA regulations is expected
• Recent experience with NDA filing(s)
• Experience in diabetes/metabolism is desirable
• Advanced writing and speaking competency, positive and proactive communication skills, proficiency with Microsoft Office Suite
• Ability to function efficiently and independently in a fast-paced, changing environment with high attention to detail
• Prioritize and recognize most important aspects of development process
• Self-motivated and willing to accept responsibilities outside of initial job description

Managing Medical Writer Resume Examples & Samples

• A minimum of 2 years experience managing people, projects and/or the work of others
• Provide leadership of and management for complex documentation projects and project teams of medical writers
• Demonstrated experience in process improvement
• Is recognized as a scientific contributor in preparation of selected regulatory clinical documentation
• Demonstrates competence in writing, editing and reviewing of clinical study reports, patient narratives, investigator brochures, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation
• With supervision, manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results. Supports the medical writing team with quality control, redaction, and coordination activities, as needed
• May participate in initiatives to improve medical writing processes and standards
• A minimum of 1 year of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry
• Ability to prepare, with supervision a subset of clinical regulatory documents (e.g., CSR shell or appendices, IB updates, patient narratives) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
• Excellent oral (including presentation) and written communication, and project management skills
• Awareness of pharmaceutical industry needs beyond clinical development
• Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Represents functional area in cross-functional teams (either internally or externally)
• Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines
• Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development (e.g., program level standards), trials (e.g., CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results
• Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve
• Ability to prepare, without supervision, core clinical regulatory documents according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
• Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development

Senior Specialist, Medical Writer Resume Examples & Samples

• Works with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development
• Contributes scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers
• Provides leadership in completing major summary submission documents (e.g., pivotal study reports, Clinical Summary of Efficacy, Clinical Summary of Safety, and Clinical Overview) to support high-quality submission dossiers
• Mentors more junior medical writers and provides leadership in completion of large writing projects
• Bachelors degree with 8-10 years of experience as a medical writer, advanced degree preferred (e.g., Masters or Ph.D. in life sciences)
• Experience preparing clinical regulatory submission documents, including CTD Module 2 summaries
• Demonstrated leadership, problem-solving ability, to work simultaneously on multiple projects, and the ability to prioritize tasks leading to timely completion of high-quality documents

Medical Writer / Senior Medical Writer Resume Examples & Samples

• Develop and manage timelines for document development
• This position requires a bachelors degree in a life sciences discipline and a minimum of 2 years biopharmaceutical industry experience
• Experience preparing clinical regulatory documents and scientific publications is crucial
• Experience with early-stage drug development (phase 1) is desirable
• Prepare routine clinical regulatory documents, including clinical study protocols, clinical study reports, and investigator’s brochures, and sections of regulatory submissions
• Assist with preparing more complex documents
• Serve as the lead medical writer for routine clinical studies
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
• Experience producing high quality scientific/medical documents
• Ability to analyze, interpret, and summarize data
• Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
• Basic project management and organizational skills
• Attention to detail related to consistency, grammar, syntax, and scientific accuracy
• Basic computer skills related to word processing, templates, table/figure creation, and literature searches
• Ph.D. (or equivalent degree) and 0 – 3 years of relevant work experience, or
• M.S. (or equivalent degree) and 1 – 4 years of relevant work experience, or
• B.S. (or equivalent degree) and 3 – 6 years of relevant work experience
• Write clinical documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy
• Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues
• Serve as the Medical Writing representative on assigned project teams
• Providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables
• Coordinate production and distribution of draft and final documents to project team and client
• Experience in writing multiple clinical study reports, and either CTD documents or study protocols
• Preferably experience in a variety of indications, particularly CNS (schizophrenia, depression, Alzheimer’s), renal disease, oncology, dermatology
• Experience with a variety of documents (CSRs, IBs, protocol/amendments, briefing books, HA responses, post-submission safety updates, and preferably submissions [clinical CTD modules]
• A flexible attitude with respect to work assignments and new learning
• Willingness to work in a matrix environment and to value the importance of teamwork
• Team leadership skills
• Extensive clinical/scientific writing skills
• Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy
• Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management
• Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review
• Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines
• Write high-quality clinical documents that support FibroGen’s goals and objectives
• Understand the key components/messages for regulatory submissions as embodied in FDA and ICH guidelines
• Identify the customers for each document, and formulate and convey key messages clearly and concisely for those customers
• Keep current with therapeutic area(s) relevant to assigned projects
• Use appropriate FibroGen stylistic conventions
• Keep up-to-date on the software needed for this position
• Mandarin technical writing skills is required
• 5 – 8 + years of industry experience as a pharmaceutical medical writer; an undergraduate degree in a scientific discipline is preferred; an advanced scientific degree is a plus
• Knowledge of, or aptitude for understanding, medicine; familiarity with the drug development process and regulatory documentation
• Ability to gather and synthesize large amounts of data
• Demonstrated ability to write clear, concise, and effective drug development documents, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately
• Understanding the role of various documents relevant to drug development in an international environment
• Good team player; excellent written and verbal communication skills, and the ability to work well with others
• Proven document planning and project management skills
• Ability to meet timelines without compromising document quality
• Ability to communicate with professionals from many functional disciplines and to work across teams (often remotely)
• Ability to ensure consistency within and across documents to avoid confusion
• Competency in relevant software applications
• Bachelor's degree in a clinical science (e.g. pharmacy, medical, nursing) or equivalent; Advanced degree preferred
• Previous experience of at least 5 years directly relevant to role and in a work setting (e.g. writing and leading medical affairs and regulatory documents); an academic setting is not equivalent for this position due to the medical affairs, client facing, Project Mgmt, and Business Development skills required
• Experience with medical affairs studies such as observational, registries, long-term safety, expanded access, dossiers (GVDs and AMCP), etc. and experience working with medical affairs teams sufficient to be able to verbalize the needs of medical affairs relative to regulatory studies
• Strong preference for someone with client facing and business development experience
• Experience in managing and directing complex medical writing projects
• Experience working in the pharmaceutical, but CRO industry preferred
• Acting as key client contact
• Preparing complex documents and providing review of others work
• Advising on technical aspects of document preparation
• Managing Project budgeting/forecasts
• Reviewing revenue budgets and adjusting resources accordingly
• Research and develop written materials to the highest scientific and grammatical standards, according to internal/client brief, displaying excellent technical accuracy and attention to detail and the ability to tailor materials appropriately for a range of educational needs and target audiences, with adherence to timelines and budgeted hours
• Incorporate internal/client/author comments using a scientifically accurate and balanced approach, and with senior support resolve any conflicts in a professional and compliant manner
• Maintain broad awareness of developments in relevant therapeutic areas to ensure scientific and clinical relevance of written materials in specific project activities. Develop understanding of the needs of clients, including the marketing/clinical relevance of key data, and work with account team to offer solutions, as appropriate
• Exercise good interpersonal/communication skills for effective and professional liaison with the internal team, clients, healthcare professionals and other key stakeholders. Actively participate in meetings with relevant internal and external stakeholders, and respond effectively to questions relating to allocated areas of responsibility
• Contribute to the development of proposals/pitches, offering scientific research expertise, as required
• Monitor and manage own projects; anticipating workload issues and working with senior medical team members to deliver to required budget and time specifications
• Diligently follow all company standard operating procedures (SOPs)
• Strong computer skills, including MS office, Word, PowerPoint, Excel, Outlook and Internet
• Experience with research tools and approaches, such as reference management/publication planning databases. Good research skills and ability to interpret scientific and clinical data
• Strong, versatile medical writing skills
• Ability to generate grammatically correct, consistent, scientifically accurate copy, using appropriate writing styles for different audiences
• Ability to perform multiple tasks and prioritize work effectively
• Ability to be self-directed and manage time efficiently
• Familiarity with current industry code of practice guidelines
• Budgetary awareness
• Prepare protocols, clinical study reports, statistical analysis plans, publications, abstracts, posters, slide presentations, and IRB submissions
• Create, edit, and maintain procedural documentation including department policies and procedures (SOPs)
• Support quality assurance efforts, assemble documentation for audits and ensure that documentation is compliant with federal regulations
• Ensure quality of the documents & manage the document review process, including securing buy-in from both internal and external stakeholders
• Liaise with client teams to ensure their needs are met
• Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions
• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards)
• As required, serves as lead writer for strategic regulatory documents and key components of regulatory submissions
• Provides leadership on functional teams that address requirements or issues related to document preparation and production
• Bachelor’s degree in science, health profession, or journalism required
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
• Knowledge of team dynamics and ability to function as a team leader
• Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project
• Maintain and enhance knowledge of regulatory guidelines and publication guidelines
• Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.Provide informal coaching to others by sharing technical information, giving guidance, answering questions
• Contribute to process improvements, suggesting opportunities where appropriate
• Provide database and other tool (eg, document management systems) expertise.Knowledge Sharing and Consultant Support
• Bachelor’s degree in a scientific, health, or technical related field, OR Bachelor’s degree in any field with at least two years of clinical development experience
• Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates)
• Graduate degree with formal research component or in life sciences
• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise)
• Experience in clinical trial process or regulatory activities
• Experience writing regulatory or clinical trial documents
• Publication experience
• Limited travel, up to approximately 10%
• Direct and lead the writing, reviewing, editing and approval of clinical documents
• Author documents while contributing knowledge of therapeutic areas, clinical drug development, and scientific areas
• Provide medical writing and editing expertise for various documents including those for clinical development and medical affairs (clinical study outlines, clinical protocols, amendments, reports, etc.), and for regulatory submission documents (IND applications, NDA, meeting packages, etc.)
• Understand and interpret data from a variety of sources and help create figures/tables to effectively communicate clinical study results
• Review documents related to clinical study reports, such as Statistical Analysis Plans and tables, figures and listings
• Ensure documents are developed according to timelines
• Learn and maintain a knowledge of relevant therapeutic areas in order to apply knowledge to various projects
• Bachelor’s degree in science with relevant writing experience OR Bachelor’s degree in English or Comunications with significant relevant scientific experience; PhD, PharmD OR Master’s degree highly preferred
• Strong organization skills and a high attention to detail
• Strong working knowledge of Adobe PDF, MS WORD, EXCEL, PowerPoint, and Project
• Experience with automated document templates and AMA style guide
• Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures
• Education to Bachelor’s/advanced degree level in a scientific discipline
• Prior experience within regulatory medical writing
• Excellent grammatical, editorial and proofreading skills
• Effective organisational and planning skills
• Motivation, initiative and adaptability
• Ability to work effectively in a team
• Providing medical writing support to Clinical Research Associates
• Writing protocols for clinical trials
• Writing clinical reports for clinical trials
• Writing Clinical Evaluation Reports
• Writing publication articles such as abstracts and journal publications
• Reviewing of medical documents authored by other persons
• Completing writing assignments in a timely manner and maintain timelines and workflow for writing assignments
• Reviewing of scientific literature
• Taking ownership of assignments by proactively consulting other project team members for information and guidance, as necessary
• Minimum of three (3) years combined medical and/or technical writing experience
• Certification through American Medical Writing Association (AMWA)
• Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines
• Direct experience writing Clinical Evaluation Reports
• Familiarity with medical terminology
• Ability to research and translate large amounts of technical information
• Understanding of clinical data
• Have expert proficiency with templates and style guide
• Demonstrated expertise in computer skills including Microsoft Word and Excel
• Persistent and detail-oriented
• Excellent ability to multi-task and prioritize
• Ability to work effectively on cross-functional teams
• Preclinical Reports and Summaries
• Pharmcokinetic, Pharmacodynamic Studies
• Toxicology Analysis
• ADME, Including Drug Interactions and Toxicokinetics
• INDs, NDAs (FDA)
• Investigators' Brochures
• Publications and Literature Reviews
• Posting to Clinical Trials Registry
• Clinical Safety and Efficacy Reports (all phases)
• Prepare documents within the required format of specific stakeholders and/or regulatory agencies
• Objective, comprehensive and clear written presentation of scientific and/or clinical data in a format commensurate with ICH and other scientific writing standards. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical regulatory documents
• Provide dedicated scientific authoring expertise to both the development and research groups
• Develop regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures
• Ensure accuracy, consistency, and quality of all documents
• Represent Medical Writing and provide medical writing expertise on cross-functional and cross-company teams
• Drive documents through multiple rounds of team review to final (ie, distribute documents for review, consolidate and resolve reviewer comments, run efficient roundtables, finalize for publication and signoff) in accordance with established timelines
• Collaborate effectively across Ironwood and with Ironwood partner companies and external experts
• Support medical writing colleagues as necessary (eg, document review, edit, and QC) and contribute to team excellence
• ≥ BA/BS and ≥ 5 years’ experience writing a broad range of clinical regulatory documents
• Great collaborator with experience working on cross-functional teams
• Strong communication, interpersonal, editorial, and organizational skills
• Working knowledge of ICH guidelines, GCP, CTD, etc
• Proficiency in Microsoft Word (and familiarity with document template use), PowerPoint, and Excel
• Ability to manage multiple documents and set clear plans and priorities
• Poise under pressure
• Scientific background
• Knowledge of GPP, ICMJE guidelines, and experience with scientific publications
• Experience with clinical trial development
• Development and updating of Investigator’s Brochures, Safety Update Reports, and other regulatory documents
• Preparation of clinical study protocols, clinical study reports or other regulatory documents supporting ongoing clinical development programs. Development of these document’s supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements
• Quality-checking documents for agreement between in-text information and the source data, and for internal consistency
• Provide overall medical writing support for ongoing programs
• The candidate must be able to work independently and efficiently with cross functional team members
• The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication
• A good understanding of medical terminology and AMA style is needed
• This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians. It will be essential to approach issues from a number of perspectives, summarizing data to draw a conclusion
• The applicant would have previous experience in leading the writing of clinical/regulatory documents, such as protocols, investigator brochures, annual safety updates, and clinical study reports. as a lead author, this person must work cross-functionally with appropriate teammates to create documents, coordinate their review, and edit through finalization
• Applicant must be able to prepare deliverables in accordance with pre-established timelines, systematically performing activities in a timely and accurate manner
• Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat are needed
• Advanced degree with 2+ years relevant writing experience
• Must possess the ability to coordinate production of deliverables and provide leadership to a project team
• Must possess independence in decision making and problem solving
• Protocol Development ( and protocol related documents: inform consent form, amendments, study concept sheets, as appropriate)
• Lead clinical trial protocol development process with CPO/Region representative (Medical Advisor, statistician, regulatory, etc...) or external authority recommended by customer
• Translating the approved trial concept sheets into executable clinical pro-tocol (and Inform Consent Form) ready for customer "Protocol Review Committee" review/approval
• Translate study scientific and operational elements into a high quality concept sheet for review and approval by Head Quarters as appropriate
• Responsible, with the clinical trial team for preparation of high quality clinical study reports. Participate in planning of analysis, meetings and data presentations to be used in study report
• Responsible for clarification of requirements from customer prior to start protocol/concept sheet/ study report development
• Incorporate input from authorities (Medical Advisor, Statistician, safety, DRA as appropriate) while ensuring that feasibility at site level, patient safety and trial objective (i.e. publication) are considered when developing the document(s)
• Coordination of the protocol, study report versions reviews and approval processes in collaboration with key contributors and customers
• Write and prepare clinical submissions documents within a team environment
• Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation
• Manage the review and approval process of clinical submissions documents; notify team of targeted review responsibilities. Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner
• Coordinate with other Clinical Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications
• Maintain and demonstrate expert knowledge of drug development process and applicable regulatory guidelines
• Such other responsibilities and projects as the company may assign
• 6+ years experience in Medical Writing in the Biopharmaceutical industry
• An advanced degree (e.g., MS, PhD, etc) may be considered in lieu of years of experience
• Ability to work within an international team
• Must be detail-oriented, thorough, and methodical
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
• Excellent problem-solving capabilities and organizational skills
• Degree (minimum BA/BS) in life sciences, clinical sciences, English/journalism, or equivalent related experience
• Moderate progressive experience in medical and/or scientific writing preferred or equivalent education and experience
• Effective presentation and interpersonal skills; team-oriented
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet
• Ideally you are already familiar with the principles of clinical research and/ or interpretation, presentation, and proofreading of clinical data or other complex information
• Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields
• Experience writing regulatory, clinical trial documents and or publications
• Experience in clinical development, clinical trial process or regulatory activities
• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise)
• Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc
• Provide informal coaching to others by sharing technical information, giving guidance, answering questions
• Recognized for technical expertise in specific document development
• Network with others to identify and share best practices globally
• Bachelor’s degree in a scientific, health, or technical related field OR Bachelor’s degree in any field with at least two years of clinical development experience
• Demonstrated project management and time management skills
• Ability to work well across cultures and time zones
• Ability to work well independently and as part of a team
• A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested
• Manage the delivery of Medical Writing activities (CEPs/CERs) and perform project management for Publication delivery across Lifecycles as specified
• Medical Writing Experience with focus on Clinical Evaluation Plans/Clinical Evaluation reports (CEP/CERs) and project management experience
• Clinical Research
• Good Clinical Practice
• Good spoken and written English
• BS degree in pharmacy or Doctoral level degree in a biomedical field
• 2 years experience in searching the biomedical literature
• 2 years experience in interpreting and using medical communication documents
• Knowledge of biomedical and pharmaceutical databases (e.g. MEDLINE, CANCERLIT, EMBASE, BIOSIS, IPA) and vendors for accessing them (e.g. DIALOG, OVID, SILVERPLATTER)
• Computer skills [word processing, spreadsheet, bibliographic management]
• Provides medical writing expertise for multiple compounds and/or projects across all therapeutic areas within CPPM
• Implements all activities related to the preparation, submission, and revision of scientific publications (eg. abstracts, posters/oral presentations, manuscripts)
• Leads the authoring, review, and approval processes with appropriate functions involved in the production of scientific publishing projects
• With input from authors, converts relevant data and information into a form that is appropriate for the target audience and meets journal or congress requirements
• Confirms completeness of information to be presented
• Proactively identifies gaps and inconsistencies and proposes ways to resolve them
• Understands/complies with appropriate conventions, proper grammar usage, format requirements per journal/congress, and internal policies to ensure preparation of high-quality scientific publications
• Independently resolves document content issues and questions arising during the writing process; drives manuscript preparation and submission to completion
• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications
• Acts as Subject Matter Expert for best practices in manuscript preparation and submission
• Maintains expert knowledge of guidances (eg, ICJME, CONSORT, GPP3) associated with scientific publications
• Coaches, mentors, and assists medical writers and provides guidance to non-AbbVie medical writers and external vendors/agencies
• Learns and applies knowledge of the therapeutic area and product to scientific publishing projects
• BS/MS/PhD/PharmD with significant relevant writing experience
• American Medical Writing Association (AMWA) certification or other preferred,
• Highly developed written and oral communication skills
• Knowledge of pharmacokinetics concepts preferred
• Familiarity with journal requirements for graphs and figures preferred
• Ability to find and correct errors to ensure consistency, clarity and accuracy within and across publications
• Excellent working knowledge of software programs (MS Office, Endnote, Adobe Acrobat, etc.)
• Extensive experience working in cross-functional team environments

Medical Writer, Research & Development Resume Examples & Samples

• Proficiency in MS Office applications (Word, PowerPoint, Outlook, Excel) and Adobe Acrobat
• Proficiency with medical literature search tools (e.g., PubMed, TOXNET, etc.)
• Proven ability to research medical/scientific topics, analyze the information, and summarize for target audiences
• Familiarity with common medical and scientific style guides and conventions
• Excellent interpersonal communications skills; ability to interact with cross-functional product development teams
• Ability to work independently and collaboratively
• Excellent organizational and problem-solving skills
• Ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents within tight timelines
• At least 6 years of medical writing experience (industry or academic) that includes research writing
• Experience in oncology
• Excellent interpersonal, negotiation, verbal and written communication skills
• Client focused approach to work
• Motivation to work consistently in a fast-paced, rapidly changing environment
• Team orientated
• Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company
• Knowledge of resource management and productivity metric management
• Strong word processing skills, including familiarity with MS Word for Windows
• Fluent in written and spoken English
• Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects
• Collaborate with the clinical team to write clinical documents for regulatory submissions, including but not limited to: clinical evaluation reports, interim and final clinical study reports, briefing documents, previous human experience summaries, investigator brochures, study protocols, and informed consents for the assigned projects
• Researches, creates, and edits assigned clinical reports, documents and scientific presentations associated with clinical research in cooperation with the Clinical Team, KOLs and physician investigators for the THV Clinical program
• Act as Scientific Communications representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies
• Request and/or conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
• Provide leadership, training, and guidance and act as a mentor to less experienced medical writers
• Evaluate the need for scientific content and assist in the creation of clinical educational materials for the global Sales & Marketing organizations
• Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues with clinical project managers, field teams, clinical data management and biostatistics groups
• A Bachelor’s degree required. Advanced degree preferred (Ph.D., MD, Sc.D., M.S., and M.P.H.)
• Minimum of 5 years scientific experience with an Advanced degree or a minimum of 7 years with a Bachelor’s degree
• Experience in development of regulatory submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients)
• Ability to provide leadership and guidance; skilled in coaching and training techniques
• Experience as author or contributor or peer-reviewed manuscripts is strongly desired
• Working knowledge of statistics is required
• Excellent writing and editing skills, and a keen attention to detail
• Strong verbal, written, and interpersonal communication skills
• Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
• Strong verbal as well as written communication skills necessary
• Ensure compliance with good publication practices (GPP)
• Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases
• Act as Clinical Program Medical Writer (as assigned). Provide process, content, and planning expertise to Clinical Trial Team, Clinical Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style
• Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents. Continually share best practices in an effort to create higher quality documents more efficiently
• Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the generation of clinical submissions documents, including SOPs, templates, and document writing conventions and styles
• Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced
• Mentor, coach, and/or otherwise assist in the training and development of (Senior) Medical Writers
• Bachelor’s degree required, Master’s or PhD preferred
• Professional certifications (e.g., AMWA, EMWA, RAPS, etc.) is a plus, but not essential
• Signifant experience in Medical Writing in the Biopharmaceutical industry or equivalent
• An advanced degree (e.g., Master's, PhD, etc) may be considered in lieu of years of experience
• Regulatory writing experience is required
• Ability to work under stress
• Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
• Expert knowledge of medical, pharmaceutical, and clinical research concepts
• Responsible for developing the non-scientific portions of a standard research protocol (such as registration, record-keeping and regulatory compliance sections). Collaborate with the investigator to draft non-scientific/clinical aspects including project scope. Review the entire protocol document for consistency, clarity, formatting and correct grammar. May assist with Letter of Intent and Informed Consent Form development
• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree with a minimum of 2 years of relevant scientific writing experience; OR appropriate combination of education and experience
• Understands and interprets financial statements and reports; reconciles financial records
• Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree; OR appropriate combination of education and experience
• Travel (approximately 0%) domestic and/or international
• Independently write clinical study reports and other regulatory documents according to ICON or client-specified formats. *
• Independently write patient narratives for serious adverse events and drop-outs due to non‑serious adverse events. *
• Independently provide additional writing and editing services (e.g. for publications) as required. *
• Advise on the content and format requirements for clinical reports and regulatory documents. *
• Perform quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs. *
• Liaise with internal groups, i.e. Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical, and Quality Assurance to ensure the timely implementation of activities related to the production of documents. *
• Independently interact with clients to obtain necessary and relevant information, and deal with queries through effective decision making. *
• Maintain awareness of the contractual and financial aspects of assigned projects and projects to which oversight responsibilities have been assigned
• Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule. *
• Be responsible for the daily management of assigned medical writing projects. *
• Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems). *
• Participate in the training and supervision of new and junior medical writers. *
• Represent Medical Writing at internal and external meetings. *
• Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks. *
• Any other task deemed reasonable by department senior management
• A Master’s degree or equivalent in life sciences or economics and, preferably, a postgraduate position in a health related discipline
• Relevant experience within a consulting or pharmaceutical industry environment
• Three (3) or more years of relevant pharmaceutical/medical writing experience
• Ability to read, analyze, and interpret clinical data from a variety of scientific sources
• Ability to develop presentations and articles for peer reviewed publications that conform to prescribed styles and formats
• Excellent demonstrable understanding of ICMJE and GPP guidelines and regulations
• Knowledge of Internet software, Spreadsheet software, Word Processing software, Graphics software (eg, PowerPoint or Prism), Bibliographic software (eg, EndNote) and any other applicable software as may be needed by the job from time to time as it evolves
• Knowledge of process for obtaining market access for drugs or devices
• Well-developed written and oral communication skills
• Ability to work effectively as part of a team
• High self-motivation
• Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals)
• To liaise with the CMRs’ medical/marketing functions on local publication activities
• Other relevant ad-hoc documents
• Participate in internal/external marketing/medical activities, e.g., expert meetings, lectures and conferences
• Contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
• Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas
• Actively participate in relevant meetings, training sessions and seminars in the department, competency anchor and relevant project(s)
• Maintain a good working relationship with stakeholders and colleagues
• ≥3 years of experience with scientific research methodology, including designing and conducting experiments, and analysing and reporting experimental results
• Experience with scientific writing in English (publications for peer reviewed journals or equivalent)
• Experience working within a global setting
• Strong understanding of external requirements related to regulatory documents
• Experience from the pharmaceutical /CRO industry
• Good experience with drug application processes to FDA and EMEA

Oncology Principal Medical Writer Resume Examples & Samples

• Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation
• Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provides feedback to their managers on development plans and performance reviews
• Provides leadership for medical writing processes, standards, and innovative initiatives
• Successful preparation of Common Technical Document clinical modules

Oncology Senior Medical Writer Resume Examples & Samples

• Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally)
• May participate in orientation and coaching of junior team members or contractor writers
• This is a remote based position. The ideal candidate will be based in NC, SC, TN or GA
• Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
• Participate actively in medical writing and cross-functional project teams
• Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
• Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation
• Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results
• Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members

Senior Medical Writer, Oncology Resume Examples & Samples

• In accordance with authors’ direction, provides medical writing and editing expertise for abstracts, posters, oral presentations, and manuscripts
• Responsible for compliance with applicable corporate policies and procedures
• Works effectively with cross-functional stakeholders
• Bachelor’s or Nursing degree required
• Experience Required
• Master’s Degree or PH.D preferred
• Experience in the conduct of clinical research/medical communications preferred
• Specialized medical writing knowledge
• Experience in medical writing of regulatory documents such as patient narratives, informed consent forms, experience papers, manuscripts required
• Expertise in the medical device industry
• Preferred experience with Respiratory Science
• Experience with Ednotes, Powerpoint, Microsoft Word preferred
• Medical device industry experience or related industry experience that demonstrates mastery and in depth knowledge of medical device and/or combination product trials and regulations
• Clinical research experience
• Strong knowledge of regulatory guidance relative to Clinical Evaluation Reports, and the essential requirements for safety and performance of Medical Devices as defined in Annex I of the Medical Device Directive 93/42/EEC and Annex I of the Active Implantable Medical Device (AIMD) Directive 90/385/EEC,(Annex I Section 6a and Annex X (MDD) / Annex 1 Section 5a and Annex 7 AIMD), the MEDDEV and EN ISO 14155
• Preferable experience in Cardio-vascular sciences
• Direct experience demonstrating mastery of medical and/or scientific writing within a medical device or related industry, preferably with writing of Clinical Evaluation Reports
• Strong complex project leadership skills and excellent interpersonal communication skills
• Functional knowledge of biostatistics with an understanding of the publications process
• Computer skills (Microsoft Word, Excel, Project or equivalent)

Senior Medical Writer / CER Specialist Resume Examples & Samples

• 5+ years experience (4+ years with Masters or 3+ with Doctorate, or Board Certified MD or DVM)
• Medical writing experience
• Clinical Research experience
• Medical device experience
• Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
• Advance degree in related field (i.e. systems, reliability, safety engineering)
• Previous experience in the application of in-depth therapeutic and device knowledge to development of clinical evaluation reports
• Analyzes complex issues and significantly improves, changes, or adapts existing methods
• Ability to work with little direction towards predetermined long-range goals and objectives. &#96
• Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states, Neuromodulation therapies and technologies
• Process improvement capability
• Ability to identify and implement solutions in addressing project issues
• Ability to achieve objectives and milestones through identification and implementation of work plans and measurements
• Ability to identify and adapt to shifting priorities and competing demands
• Ability to maintain composure in difficult circumstances, and identify and overcome obstacles
• Strong knowledge and understanding of Good Clinical Practices and regulatory standards
• Excellent critical and analytical thinking skills
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills
• Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development
• Strong ability to determine and pursue courses of action necessary to obtain desired results
• Proficiency in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel)
• High attention to detail and accuracy
• Ability to identify customer/stakeholder requirements, and constructively respond to feedback/comments/inquiries
• Project management capability
• Understand and interpret study objectives and clinical trial data and the regulatory and scientific requirements of the documents we prepare
• Confidently work with others to develop study protocols from brief outlines, and take responsibility for a variety of clinical documents for a wide range of both international and local sponsors, across all therapeutic areas
• Interact directly with international project team members and sponsors, proactively manage his/her own deliverables, and identify and respond appropriately with solutions to any potential issues and problems
• Multi-task, balancing project lead roles with review responsibilities for others, and helping out colleagues in the team on a planned or ad hoc basis
• Work with minimal direction on most assignments, identify project needs, and create project timelines
• Review the work of others and provide appropriate feedback
• Minimum of a Master’s degree in a related field required. PhD or other doctorate degree preferred
• A minimum of 4 years relevant medical, scientific and/or healthcare writing experience is required
• The ability to interpret, analyze and summarize/visualize clinical and statistical data obtained in scientific research is required
• A good understanding of experimental methods and study design is required
• Experience in the real world evidence and health economics and outcomes research fields, including studies utilizing claims data and/or EMRs/EHRs is preferred
• Superior writing and editing skills are required. Lead writer experience is preferred. Documents must be of high quality with respect to scientific content, organization, clarity, accuracy, format and consistency
• Relevant pharmaceutical, health outcomes, clinical and/or scientific experience is preferred
• Exposure to pharmaceutical strategies and tactics to meet both commercial and scientific communication objectives for a given product is preferred
• An understanding of statistical analysis is preferred
• Experience with templates and document management systems are required
• Excellent skills in collaboration and influencing are required
• Strong interpersonal and communications skills (both written and oral) are required
• Proficiency with computer, word processing and presentation (i.e. PowerPoint) and basic Excel skills are required
• Strong time-management and project planning skills are preferred
• Experience with preparation and submission of publication deliverables (abstracts, posters, manuscripts) is preferred
• Working knowledge of regulatory and commercial compliance issues relating to conducting research and dissemination of scientific information preferred
• This position may require up to 10% domestic travel.Medical Writing

Senior Medical Writer, Work From Home Resume Examples & Samples

• Thorough understanding of GCP, ICH guidelines and local regulations
• Knowledge of clinical trials design, the oncology disease process, basic statistics, pharmacokinetics and other aspects of the drug/clinical trial development
• Excellent problem-solving, planning, analytical, and organizational skills
• Strong verbal, written and interpersonal communication skills are essential
• Skill with Microsoft Office products, including Outlook, Word and Excel
• Flexible attitude with respect to work assignments and new learning opportunities
• Ability to work within deadlines
• Ability to multitask and prioritize workload with attention to detail required
• Three years minimum of relevant medical writing experience or relevant clinical research experience
• Two years’ experience as a CRA/Study Manager, compliance auditor, or a combination in healthcare, clinical research or other science-related field – if document preparation was a primary responsibility
• Experience with preparation of clinical and/or regulatory study-related documents and/or research publications desired; experience with regulatory documents and processes beneficial
• Clinical research/medical writing experience: experience, including phase I- III, in writing multiple clinical study reports, and either CTD documents or similar, or study protocols

Clinical Research Medical Writer Resume Examples & Samples

• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biological/biomedical science or related field or 4 years related experience in lieu of degree
• A minimum of two (2) years’ experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and/or regulatory technical writing/editing
• Experience participating in the preparation of clinical documents for regulatory submissions (e.g., clinical protocols, Investigational New Drugs [INDs])
• Ability to effectively communicate both verbally and in writing with demonstrated expertise with grammar, syntax, and format
• Ability to work in a clinical research regulatory setting, both independently and within a team, to coordinate, negotiate and facilitate the program goals
• Proficiency in word processing systems, i.e., Microsoft Word, MS Office, or similar systems
• Familiarity with therapeutic area of allergy and infectious diseases
• Clinical trial reports (CTRs)
• Clinical trial results presentations for distribution to clinical investigators
• Investigator’s brochures (IBs)
• Clinical summary documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs))
• Solid experience with drug application processes to FDA and EMEA

Oncology Managing, Medical Writer Resume Examples & Samples

• Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
• Active involvement in professional organizations
• Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)
• Prepare clinical submission documents for a regulatory audience, within a team environment, according to APV SOPs and templates
• Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner
• Participate in the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines. Share expertise within Medical Writing and therefore across Therapeutic Areas
• Acts as Lead Medical Writer on any type of writing project, with limited guidance from senior staff, and consistent high quality and efficiency
• Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed
• Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance
• Offers proactive solutions and advice to customers as appropriate to experience
• Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognized as appropriate
• Provides senior review and guidance for documents prepared by junior staff
• May act as Project Manager for stand-alone Medical Writing projects or as primary medical writing customer contact for one of our partnerships
• May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking

Safety Medical Writer Resume Examples & Samples

• Medical Doctor, Dental doctor, Master degree in pharmacy or equivalent medical and scientific background
• Experience with scientific writing in English (publications or equivalent)
• Specific personal and job-related demands (communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, personal traits necessary in the job, etc.)
• Understands and interprets data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, tables, and published literature
• Creates figures and tables for publications that effectively communicate the data and adhere to journal/congress requirements
• Coordinates the review, approval, submission, and production of publications
• Effectively manages all assigned publication projects, including outsourced projects to vendors
• Utilizes Datavision publication management system, and ensures accuracy of publication records and resourcing tools for assigned publication projects
• Learns and maintains therapeutic area and product knowledge and applies to projects
• Maintains current awareness of good publication practices and editorial policies and applies to publishing projects
• Addresses document content issues and questions that arise
• Independently identifies conflicts affecting assigned publications and resolves or elevates to ensure resolution
• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
• Experience working in the pharmaceutical/CRO industry preferred
• Solid medical writing skills, including grammatical, editorial, and proofreading skills
• Ability to interpret and present complex data accurately and concisely
• Effective administrative, organizational and planning skills; attention to detail and quality
• Ability to work on own initiative and effectively within a team
• Experience in clinical documents related to late phase studies
• NDA experience with active contribution in planning and preparation of summary documents is required
• Facilitate Clintrials.Gov results postings
• Ability to independently plan and prepare Clinical and Regulatory Documents
• Flexibility/adaptability to work in a fast-paced and dynamic environment
• Proficient with MS Office and other related software programs
• Experience in managing people and projects
• Experience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame
• 5+ years of industry experience as Medical Writer
• Participation as writing lead on at least one NDA/MAA submission

Medical Writer Novella Clinical Resume Examples & Samples

• Prepares Sponsor documents that include but are not limited to Clinical Study Reports, protocols, manuscripts, abstracts, Investigator’s Brochures, integrated summaries of efficacy and safety, informed consents, patient narratives, responses to health authorities, and clinical trial results posting (ClinicalTrials.gov)
• Ensures that clinical documents comply with FDA regulations, ICH Guidelines, and appropriate SOPs
• Will be responsible for creating timelines associated with writing projects and will need to work within the budget assigned per project
• Coordinates the internal team, QC, and QA review of documents
• Will be in direct contact with internal and Sponsor team members
• Reviews and edits documents written by other departments, as necessary
• Prepares clinical documents for electronic publishing
• Explains and instructs information systems concepts and procedures to non-technical staff
• Ability to research and review clinical content effectively and translate clear and concise messages
• Excellent communication skills (oral and written)
• Must have outstanding analytical and research skills
• Must have the ability to decipher complex clinical and statistical data
• Requires an understanding of clinical regulatory documentation requirements
• Proficient computer skills, specifically with the use of MS Word templates and style features, Excel, and PowerPoint
• Displays knowledge of standard editorial/style conventions (eg, AMA Manual of Style)
• Proven ability to manage multiple projects and to work well in a collaborative environment
• Ability to work independently and be a team player
• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements
• Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Takeda requirements and processes across development programs
• The Principal Medical Writer Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision
• At least 5 years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred
• Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions
• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers
• The ability to manage multiple and varied tasks with enthusiasm and to prioritize your work while paying attention to details
• A bachelor’s degree in Life Sciences/Health-Related Sciences or equivalent experience
• Fluency in written and spoken English
• Creation and maintenance of technical documentation for products manufactured in Wiesbaden or other Abbott sites
• Create, update and maintain technical documentation
• Apply change control for technical documentation
• Use different document management systems (e.g. APLM, DMS, ELN) to obtain technical data
• Use different document management systems (e.g. DTS, IRIS) for technical documentation storage and tracking
• Work in conjunction with Technical Operations, R&D, Quality, Compliance, Medical Affairs and Regulatory functions in Wiesbaden or other Abbott sites
• Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience
• Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed
• May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development
• May present on standard Medical Writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on Medical Writing to other Quintiles groups
• May act as Project Manager for a small stand-alone Medical Writing project (e.g. protocol or CSR). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking
• Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing
• May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs
• Bachelor's degree in a life science-related discipline, with at least 3.5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and reports; or equivalent combination of education, training and experience
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents
• Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance
• Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions
• Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority
• Ability to effectively review a statistical analysis plan
• Knowledge of regulations relevant to medical writing
• Ensures a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards
• Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers
• Experience as a Medical writer (preferably >3 years), or equivalent, or presenting relevant specialist qualifications (eg, PhD, PharmD)
• Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
• Detail-oriented with excellent inter-personal and communication skills
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system
• Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment
• Specific knowledge of company-targeted therapeutic areas is strongly desirable
• Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Q2 Solutions SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review
• Participates in both internal and external project team meetings and liaises directly with the customer on medical/technical writing issues, as appropriate and with senior support as needed
• Facilitates appropriate internal review of assigned documents and takes responsibility for on-time delivery
• May perform QC review of documents or parts of documents prepared by more senior staff
• Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff
• Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing
• Complies with Company SOPs and participates in the implementation of new SOPs
• Familiarity with the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
• Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results
• Ability to give a simple presentation to a project team and/or customer, e.g. on medical/technical writing processes
• Ability to identify inconsistencies and deficiencies in statistical output as related to acceptance criteria according to SOPs
• Ability to work on several projects at once while balancing multiple and overlapping timelines
• Ability to assess workload and suggest prioritization to senior staff
• Demonstrated abilities in collaboration with others and independent thought
• Demonstrates confidence and maturity in most routine medical/technical writing situations
• Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW)
• Careful attention to detail and accuracy
• Must be computer literate
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Serves as primary author who writes and provides input on routine documents such as abstracts, posters, standard response letters, manuscripts, clinical study reports, and study protocols, and summarizes data from post-approval/MARO studies
• May assist with unique and/or more complex clinical and scientific and program level documents, such as customized written responses, REMS/RMPs, and review articles
• Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results
• May assist in program management and/or proposal activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables
• Represents the department at project launch meetings, review meetings, and project team meetings
• Effective medical writing skills, including grammatical, editorial, and proofreading skills
• Effective administrative, organizational, and planning skills; attention to detail and quality
• Working knowledge of regulations applicable to project work as well as drug development process
• Sound judgment and decision-making skills
• Good computer skills and skilled with the use of document templates
• Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Development of scientific content (including slide decks, monographs, abstracts, article reviews, congress reports, etc…)
• Tasks included in the assignments
• Native English speaker with a solid understanding of Medical English
• Must have a Health Science Degree (Biology, Pharmacy, Medicine)
• A minimum of 2 years of medical writing experience
• Ability to communicate medical/technical information to a wide variety of audiences
• Ability to work in a deadline-driven environment
• Attention to detail and absolute reliability in meeting delivery deadlines
• Bachelors Level of Degree in the life sciences or communications/journalism field of study
• 5+ years of demonstrated experience in medical writing/editing in the medical device, pharmaceutical, or CRO environment
• AMWA or advanced degree (MS/MPH/MA or PhD) preferred
• Approximately 3-5 years experience in the preparation of clinical documentation
• Ability to write fluent and grammatically correct English with an understanding of medical and scientific terminology and procedures
• Good word processing skills
• Good organizational and time management skills
• Ability to work to tight timelines while maintaining accuracy
• Ability to work to a variety of client-driven specifications
• Good team player
• Familiarity with quality assurance and quality control
• Acting as a lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed
• Support more experienced writers with the preparation of complex clinical documents
• Interpretation of clinical, pharmacokinetic, pharmacodynamics and statistical results as appropriate
• Production of scientific publications and other documents (e.g. abstracts, posters, manuscripts etc. )
• Coordination of other writers on CSR appendices compilation and narrative projects
• Preparation and review patient safety narratives and CSR appendices
• Timely delivery of high quality documents to internal customers and Sponsors
• Fostering excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time
• Independent preparation of clinical study protocols and clinical study reports (CSRs), and other documents as needed for lower complexity studies
• Support for more experienced writers with the preparation of clinical study protocols and CSRs, and other clinical documents as needed
• Preparation and review of clinical documents such as patient safety narratives and CSR appendices
• Delivery of high quality documents to internal customers and Sponsors
• Provision of training for Associate Medical Writers and other staff as appropriate

Associate Medical Writer Resume Examples & Samples

• Excellent command of written and spoken English
• Knowledge of MS Word
• Good organizational and time management ability
• Scientific or Clinical research experience desirable
• Minimum of 3 years’ experience in the preparation of clinical documentation
• Experience with Regulatory Guidances for ICH-E3 Clinical Study Reports and some familiarity with the Clinical (Efficacy or Safety) Sections of the Common Technical Document (CTD)
• Expertise in a specialized area of Medical Writing which is required for production of critical regulatory documents (e.g. patient narratives and pharmacovigilance documents)
• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biological/biomedical science or four (4) years of experience in lieu of degree
• No additional experience beyond a Bachelor’s degree
• Knowledge of Department of Health and Human Services (DHHS) regulations, International Conference on Harmonization/Good Clinical Practices (ICH/GCP), Food and Drug Administration (FDA), and Office of Human Research Protections guidelines
• Must be able to obtain and maintain a security clearance
• Experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and/or regulatory technical writing/editing would be a plus but does not exclude those who do not

Medical Writer / Senior Resume Examples & Samples

• Write and edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
• Represent medical writing on project teams through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
• Participate in the development of abstracts and slides or posters presenting clinical study data to medical congresses and the development of primary manuscripts for peer-reviewed journals
• Prior NDA/BLA/MAA submission experience required; eCTD preferred
• Must have a solid understanding of FDA/ICH guidelines and GCPs
• Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred
• Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment
• Background in oncology drug development is a plus
• Typically minimum 3 years medical writing experience including 1 year as medical writing project lead
• In-depth knowledge of MS Word
• Knowledge of ICH guidelines applicable to medical writing
• Good understanding of medical/scientific terminology and experience in data analysis and interpretation
• BS/BA in a scientific discipline(or licensed certification) with 4+ years relevant writing experience or
• Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
• Must possess the ability to manage large projects with minimal supervision
• Must demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing
• To stay abreast of the latest pharmaceutical developments by finding, reading and comprehending FDA drug and device alerts, medical white papers, Big Pharma reports, SEC and court filings
• To supplement FDA materials with other high-level sources
• To write accurate accounts of prescription drug or device histories and side effects for general information websites and legal websites
• To fact-check and proof existing and new web pages, news articles and blog posts
• To write (and sometimes ghostwrite) content for outside blogs and websites
• To support the Managing Editor by serving as a resource for other writers on the team
• To work a 40-hour week, Monday through Friday, in an office setting
• Experience reading and writing about Big Pharma
• Editing or proof-reading experience
• Experience dealing with lawyers on a professional level

Senior Scientific Medical Writer Resume Examples & Samples

• Include assuring quality and timely preparation of clinical documents as assigned, including clinical study reports, clinical study protocols, and support for clinical summaries and overviews
• Act as the medical writing expert responsible for managing, writing and editing of study level documents, and supporting submission level documents
• Provide full lifecycle support from clinical study concept and protocol through regulatory dossier preparation and submission
• Assist the Project Medical Writer in the development of clinical document content used to support successful global clinical development, approval and marketing of new drugs
• Implement the content strategy for all clinical documents as assigned
• Drive the design of all assigned study level documents in support of the Global Clinical Development Plan (CDP) under the leadership of the Project Medical Writer
• Independently author study level documents (collaborating with the team), supports project level submission documents under the leadership of the Project Medical Writer, implements project level data presentation and messaging standards for the assigned documents, validates individual study protocol design and clinical study report (CSR) key messages based on the strategy provided
• Be accountable for the format, content and adherence to global and electronic publishing standards of the individual clinical documents that he/she is the author of
• Mentor and coach Associate Scientific Medical Writers
• A Bachelor’s Degree in natural sciences (Master’s Degree or PhD highly preferred)
• 6+ years experience in the pharmaceutical industry or if an advanced degree in natural sciences, minimum of 3+ years experience in the pharmaceutical industry
• 3-4 years’ experience in medical writing within Pharmaceutical or CRO industry, preferably in the field of oncology
• Experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions) in a global team environment are highly preferred
• The incumbent must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA)
• The incumbent must have a thorough understanding of the overall drug development process. Specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions is required
• The incumbent must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
• The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas. The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Global Development organization
• Ability to work on-site in Whippany, NJ
• Responsible for planning and preparing high quality medical writing deliverables (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, risk management plans, pharmacovigilance ad hoc and periodic reports, briefing books), presentations (e.g., abstracts, posters, Advisory Committees, Advisory Boards) and manuscripts that support the clinical development and regulatory requirements for CR&D
• Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
• As a guide, a minimum of 4 years Clinical experience in the role of medical writer
• Excellent level of English language proficiency
• Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and templates
• Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions
• Coordinates the activities of Takeda, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues
• As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions
• The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision
• Serves as medical writing lead on scientific publications or clinical regulatory documents. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US)
• Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
• Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements
• Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Identifies conflicts affecting writing projects and resolves or elevates to ensure resolution. Ensures all clinical regulatory electronic document deliverables are pr
• Understands, assimilates, and interprets sources of information with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of information to be presented. Challenges conclusions when necessary. Identifies and proposes solutions to resolve issues and q
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs
• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory documents
• Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary
• Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with all current industry requirements as they relate to scientific publications or clinical regulatory submissions, including electronic submission/approval standards
• Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements
• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies
• Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
• Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
• Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects
• May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review, and attending bid defense meetings and capabilities presentations
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Advanced interpersonal, oral and written communication, and presentation skills
• Excellent judgment; high degree of independence in decision making and problem solving
• Ability to mentor and lead junior level staff
• 25 days holiday (increasing with length of service)
• Pension scheme (5% of annual salary)
• Bonus scheme
• Childcare vouchers
• Serves as medical writing lead on clinical regulatory documents. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US)
• Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
• Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate
• Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols. Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies
• Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Learns and applies knowledge of therapeutic area and product to publishing projects. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards
• Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve
• Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
• Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals
• Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Advises teams regarding compliance with clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to projects. Must continually train/be compliant
• Writing, editing, formatting, and amending Investigator’s Brochures, clinical study protocols, Informed Consent Forms, and other clinical regulatory documents
• Working independently to perform background research, writing and editing clinical and regulatory documents through draft, review, finalization and sign-off stages; summarizing data for FDA submissions, publications, and presentations
• Acting as a technical lead in Medical Writing, adhering to appropriate format and style guidelines and ensuring high quality documentation with responsibility for ensuring proper Quality Control of documents produced
• Achieving objectives by liaising with internal functional groups, such as data management, preclinical, regulatory affairs, and clinical research, as well as with external CRO’s
• Familiarity with ICH E3 and GCP guidelines
• Ensuring that all activities are conducted in compliance with any pertinent regulatory and statutory requirements and in accordance with scientific standards, ethical and professional values, established priorities, policies and practices of the company
• Staying up-to-date with professional information and technology through independent study and conference attendance
• BSc in a related life sciences discipline, Masters degree preferred, with a minimum of 5 years’ experience or an equivalent combination of education and experience
• Medical writing experience in the biotech/pharmaceutical industry preferred
• Excellent ability to organize and interpret materials for written documents, and a demonstrated track record of writing clinical documents
• Ability to work effectively independently or as a part of a team
• Comfortable managing multiple projects and ability to adapt to changing priorities
• Excellent knowledge and ability with MS Office software; advanced user level in MS Word, Excel and Powerpoint
• Strong understanding of clinical development
• Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Advises teams regarding compliance with clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant
• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies
• Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
• Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
• Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes
• May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications
• Excellent oral and written communication skills with strong presentation skills
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization
• A solid understanding of the clinical development process, including the documents that are required at each stage
• Excellent written, verbal and presentation skills
• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates
• Prior experience with submissions in Common Technical Document (CTD) format

Associate Submission Medical Writer Resume Examples & Samples

• Independently author submission documents and implement the submission authoring strategy under the leadership of GMW Strategist or Submission Medical Writer
• Drive the design of all assigned project level submission documents in support of the Global Clinical Development Plan (CDP) under the leadership of GMW Strategist or Submission Medical Writer
• Validate the individual study protocol design and clinical study report (CSR) key messages
• Contribute to the project level data presentation strategy and messaging standards under the leadership of GMW Strategist or Submission Medical Writer
• Mentor Senior Scientific Medical Writers and Scientific Medical Writers (internal and outsourced) in developing expertise in writing submission documents
• Bachelor’s degree in natural sciences and a minimum of eight (8) years of experience or an advanced degree in natural science and a minimum of five (5) years of experience in the pharmaceutical industry
• At least six (6) years of experience in regulatory medical writing, three (3) of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.)
• Experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions)
• Thorough understanding of the overall drug development process
• Specific knowledge of the research report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions
• In depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA)
• Excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
• Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas
• Experience in supporting diverse therapeutic areas
• Advanced degree is preferred
• Additional qualifications in medical writing (AMWA, EMWA, or RAC)
• Experience working in the pharmaceutical/contract research organization (CRO) industry is preferred
• Acts as Lead Medical Writer on most types of writing project, with guidance from senior staff as needed, and consistent high quality and efficiency
• Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Identifies project needs, negotiates and tracks project timelines, and implements client requests with senior guidance
• Offers proactive solutions and advice to customers as appropriate to experience, seeking guidance from senior staff as needed
• Produce high quality and timely communication materials (e.g., manuscripts, reports, abstracts)
• Must be able to grasp quickly the objective of a study and the targeted messaging based on background materials provided (e.g., study report, manuscript outline)
• Handle all aspects of a manuscript submission and follow up with journal editors; manage projects to ensure that authors respect deadlines and respond to comments promptly and effectively
• Act as a resource to colleagues to help them improve their writing and data presentation skills in the development of tables, graphs and other material ultimately incorporated into client messaging documents

Senior Medical Writer, Early Phase Resume Examples & Samples

• Compiles, writes, and edits medical writing deliverables and serves as Medical Writer on inter-department and intra-department project teams with moderate supervision. Provides medical writing deliverables covering primarily phase I research
• Creates writing deliverables, under the guidance of the Research Scientist, that include, but may not be limited to
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables
• Adheres to established regulatory standards including, but not limited to, ICH-E3 guidelines, Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects on-time and on-budget
• Performs on-line clinical literature searches as requested
• Establishes and maintains the ‘medical writing’ standards for Clinical Pharmacology projects
• Creates templates for various types of clinical documents
• Reviews all writing of Clinical Pharmacology projects to ensure consistency and accuracy, a professional layout, and that all materials are updated as needed
• Trains and supports the Clinical Pharmacology team in relevant aspects of pertinent software (e.g., MS Word, MS PowerPoint, Reference Manager, etc.)
• Designs and prepares posters, brochures, slide presentations, etc. as required
• Initiates and leads the copy editing and proofreading process for Clinical Pharmacology documentation in accordance with corporate Standard Operating Procedures
• Prepares materials for presentation and publication
• Communicates workload, resource needs, and priority issues with line manager and assists in resolving conflicts
• Support development of clinical submission documents, eg, CSRs, CTD summary documents (module 2.7), and Clinical Overviews (2.5); prepare and manage, create and/or review
• May need to lead submissions or new programs
• Respond to HA questions as needed (eg, prepare response documents)
• Prepare IBs and other documents to support clinical programs
• Any other related tasks as may be required, eg, review of documents and QC as needed
• All services performed shall be in accordance with company SOPs/WPs
• A contract medical writer may be assigned to one or more documents and may have a lead or supportive role

Trainee Medical Writer Resume Examples & Samples

• Excellent interpersonal, verbal and written communication
• A flexible attitude with respect to work assignments and training
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix management environment and to value the importance of teamwork
• Knowledge of Microsoft Office suite of programs
• Knowledge of word processing, spreadsheet, database and e-mail applications required (MS Office and Adobe Acrobat recommended), with the ability to understand and adapt to various IT systems
• Scientific background essential; at least two years’ experience in any discipline in the contract research, pharmaceutical or biotechnology industry (experience in the contract research environment preferred)
• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
• Writing effective branded and unbranded medical copy targeted to a physician/healthcare professional (HCP) audience
• Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, speaker videos, online graphic banner and text ads (multiple sizes), emails (including newsletters, formulary data, and/or safety alert-type communications)
• Collaborating in creative brainstorms and internal reviews with graphic designers, account and marketing managers, web producers, product managers, editors, and others to accomplish project objectives
• Providing vital support (including annotation work) to a client services team that helps brand managers and their medical/legal/regulatory (MLR) teams steer all promotional pieces through review and approval processes
• Actively participating in meetings with clients (project kickoffs, status calls, etc.)
• BA/BS, preferably in a scientific/medical discipline. Proven ability to write clinically sound, balanced copy with marketing finesse a must, even if you possess an MA/MS
• 4+ years’ relevant experience in a high-volume, process-oriented pharmaceutical advertising agency, medical education, or other healthcare communications writing role (focus should be on online promotional content development, preferably with some exposure to mobile environments)
• Ability to absorb new therapeutic areas quickly
• Demonstrated talent for teambuilding, particularly with Client Services-type (Account Managers), Web Services, and Editorial/Creative groups
• Some understanding of pharmaceutical company MLR requirements and submission systems, FDA guidance, and/or OPDP regulations desired, but not required
• Writing effective promotional copy (branded and unbranded) targeted toward a physician/healthcare professional audience
• Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, emails, speaker videos, online graphic banner and text ads (multiple sizes), etc
• Collaborating in creative brainstorms and internal reviews with graphic designers, account and marketing managers, web producers, product managers, editors, and more
• Providing vital support (including content strategy and annotation work) to a client services team that helps brand managers and their medical/legal/regulatory (MLR) teams steer all promotional pieces through review and approval processes
• Troubleshooting strategic content- and process-related issues with other internal departments (including copyeditors, creative services, marketing personnel, etc.), as necessary
• 4+ years’ relevant experience in a high-volume, process-oriented pharmaceutical advertising agency, medical education, or other healthcare communications writing role (ideally, with a focus on online promotional content development, preferably with some exposure to mobile environments)
• Demonstrated talent for teambuilding, particularly with account managers, web developers, designers, etc

Immunoscience Medical Writer Consultant Resume Examples & Samples

• Writes, develops, fact checks, and edits content for deliverables, such as AMCP Dossiers, scientific presentations for payers, and responses to address specific unsolicited payer and Health Care Provider requests for health economic or outcomes information
• Conduct literature searches in databases such as EMBASE and Pubmed/Medline
• Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents
• Ensures deliverables that are developed to appropriately respond to inquiries from payers and Health Care Providers comply with applicable laws, regulations, guidance’s and policies and procedures
• Maintains awareness of current industry practices that pertain to Medical Information
• Complies with the reporting of adverse effects and product complaints to Worldwide Safety and Surveillance

Medical Writer Associate Resume Examples & Samples

• Assist the managing editor of the journal with the daily operations of the journal including managing submissions, identifying reviewers, and submitting manuscripts for publication
• Assist the managing editor with maintaining deadlines and coordinating the publication process, including communicating with editors, authors, and the publisher
• Assist the managing editor with the maintaining a comprehensive database of all authors, manuscripts, and peer reviewers
• Assist in the development of effective strategies for increasing journal promotion and growth, such as social media
• Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, speaker videos, online graphic banner and text ads (multiple sizes), emails (including newsletters, formulary-data, and/or safety alert-type communications)
• BA/BS in English, Journalism, Communications, or some Medicine/Health-related field is preferred or equivalent years of professional experience
• Proven ability to write clinically sound, balanced copy with marketing finesse a must, via writing sample
• 4+ years’ relevant writing experience in a high-volume, largely digital communications based writing role
• Process-oriented pharmaceutical advertising agency, medical education, or other healthcare communications a plus
• Experience targeting primarily non-US-based (global) physician/HCP audiences (focus should be on online promotional content development, preferably with some exposure to mobile environments) preferred
• Bilingual English/, Spanish, or French, German or Portuguese language skills (reading, writing, and speaking in a professional medical communications capacity) are a plus
• Some understanding of pharmaceutical company MLR requirements and submission systems, EMEA or FDA guidance, and/or OPDP regulations desired, but not required

Senior Principal Medical Writer Resume Examples & Samples

• Serve as Medical Writing Lead for designated TA, working closely with the Clinical Leads, Clinical Scientists, other Clinical team members and Submission teams, as applicable, to gather the information (timelines; projects; documents) to forecast and budget resource needs for medical writing deliverables in Global branded R&D
• Assemble and update the budget for medical writing deliverables in the assigned TA, with the support of the Senior Director, Medical Writing or designee
• Review documents as Medical Writing Lead for programs within a designated TA
• Serve as subject matter expert representing Medical Writing on cross-functional teams
• Participate in selecting medical writers (primarily external). Train and mentor new staff and ensure staff adheres to Company systems and standards
• Perform the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on adherence to business objectives and Company standards, as well as organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar
• Knowledge of clinical operations, health sciences and biostatistics is a plus working knowledge of document management system (eg, Documentum®)
• Oral and written communication
• Demonstrated ability to understand and represent data clearly in written text
• Promoting innovation and process improvement
• Assigning, reviewing, and planning medical writing assignments for in-house or contracted staff
• Participating in performance evaluations
• Professional leadership ability

Principal Medical Writer Scientific Publications & Planning Resume Examples & Samples

• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical
• 3 years of experience in experimental design and clinical/preclinical data interpretation preferred
• Knowledge of biostatistics preferred
• Supervise medical writing of other Medical Writers or contractors for assigned documents in the designated therapeutic area (TA)
• Prepare high-quality clinical documents including clinical study reports, briefing books, clinical protocols, and integrated summaries for regulatory submissions
• As Medical Writing Lead, responsible for quality and adherence to established timelines for all Medical Writing deliverables in the designated TA
• An understanding of clinical drug development, clinical trials, and global regulatory submission regulations is desired
• Proficient skills in Microsoft Word, Microsoft Excel, Microsoft Outlook, Adobe Acrobat are required
• Skills in Microsoft PowerPoint, Microsoft Project, Microsoft Visio are a plus
• Decision making, judgment, and problem solving
• Initiative and accountability
• Implementing and facilitating adherence to processes
• Maintaining and coordinating medical writing activities
• Participating in the selection and training of new employees
• Interpersonal relationships, team building, motivating employees, and influencing others
• Developing people and staffing

Oncology Medical Writer Resume Examples & Samples

• Develop and update biomarker medical communication content per clinical development program, publications, data releases, congress activity, customer inquiry trends, treatment landscape, market events, etc
• Conduct literature searches, author medical communications content and perform data accuracy reviews for medical communications content on BMS oncology assets
• Literature search: identify and review all relevant data available in published literature to ensure in-depth and relevant medical data is reflected in all deliverables
• Medical writing: author medical standard responses, Q&As, slide decks, and training materials that are succinct and scientifically rigorous
• Data accuracy review: perform data accuracy reviews of all deliverables to ensure all content is supported by available data/references
• Support development of biomarker/translational medicine training deliverables on disease state, product overviews, and relevant market events to ensure readiness to address customer inquiries
• Consistently maintain in-depth knowledge of oncology, biomarker and evolving competitive landscape
• Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; staying informed about applicable clinical landscapes and trends
• Write and edit CERs, Clinical Summaries, including special summaries from raw data for submission to regulatory agencies, adverse event narratives, comprehensive reviews, and other projects requiring skills in medical communication including but not limited to CSRs, protocols, abstracts, manuscripts, white papers, publications, IBs, integrated summary documents, clinical portions of INDs, NDAs and ANDAs as well as SOPs
• Lead cross functional coordination in order to manage medical writing deliverables
• Ensure appropriate communication on project-related matters within the project teams as it relates to medical writing deliverables
• Establish working relationships within Quality Assurance and divisions to ensure client satisfaction of medical writing deliverables
• Ensure document content and style adheres to Good Clinical Practice (GCP), International Conference of Harmonization (ICH) or other appropriate regulatory guidelines and complies with SOPs
• Attend and participate in Risk Analysis meetings for all divisions. May participate in audits
• Define and manage medical writing resource needs and establish contingency plans for key resources for assigned projects
• Initiate and participate in process improvements to templates and SOPs to enhance the efficiency and the quality of the medical writing work performed on assigned projects
• Accountable for developing and incorporating in-depth knowledge of product areas, current developments in the field, and of current literature
• Bachelor’s degree and at least 4 years’ experience developing/writing medical documents such as: Clinical Evaluation Reports (CERs), Investigator Brochures (IBs), protocol synopses and protocols, literature reviews, clinical study reports (CSR), narratives, integrated summary documents, clinical portions of INDs, NDAs, ANDAs (eCTD modules) as well as SOPs
• Responsible for the creation and oversight of project plans, which includes timeline management, preparation of business-critical regulatory documents, and the quality of key deliverables
• Independently produces high quality, medically accurate analyses of clinical and post-marketing data for internal and external customers in written format under the direction of the Senior Medical Writer
• Critically reviews and edits the analyses of the Scientific Writer, assuring that documents are of the highest quality, appropriate for the designated audience, and reflect current medical standards
• Performs job responsibilities in collaboration with the Senior Medical Writer, Medical Safety Experts, management, and cross-functional areas within Medical Affairs, Regulatory Affairs, Clinical Development and the Product Safety Teams
• Expert on applicable writing styles and standards, ensuring deliverables meet organizational, regulatory, and customer needs
• Utilizes a variety of resources to support conclusions/assumptions and demonstrates sound medical judgment regarding causality based on the application of clinical experience, standards of care, and regulatory guidelines
• Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions, toxicity and medication errors during periodic report preparation. This includes the consideration if safety data qualify as a new safety signal or as a new identified or potential risk, or may potentially alter any previous signal or risk assessments
• Proactively understands regulatory framework, trends & requirements related to Pharmacovigilance, clinical studies and global drug development
• Is accountable for the timely preparation of assigned periodic reports
• Requires some oversight/guidance
• Minimum 3 years industry experience in Pharmacovigilance, Strategic Medical Affairs or Clinical Development
• Understanding and initial experience in Pharmacovigilance in the pharmaceutical industry or academia or equivalent
• Understanding of medical conditions and disease state entities, able to critically evaluate medical data
• Experience in preparation of periodic safety reports
• Experienced professional operating within the international arena, and working across functional areas
• Proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills (e.g. ISI Writer)
• Very good communication and presentation skills (oral and in writing) in English

Senior Medical Writer / Project Manager Resume Examples & Samples

• Function as a key contributor in planning & preparation of high quality documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
• Coordinate and oversee MW service providers
• Manage document reviews, version control and timelines with CROs and other medical writing consultants/contractors
• Assist in technical preparation of eSubmission ready documents
• Engage in background research related to documents in development
• Collaborate with various functional areas in Clinical Development and Medical Affairs, Regulatory, and Project Management in planning and preparation, and review of clinical and regulatory documents
• Stay current on medical writing best practices and regulatory guidelines
• Actively participate and contribute to the strategic development of assigned projects
• Represent Medical Writing on study teams/clinical teams
• B.S. in a relevant scientific field preferred
• 3+ years of industry experience as Medical Writer or Medical Writing Operations
• Experience in clinical regulatory documents
• Experience working with standard document templates/styles to support electronic (eCTD) submissions
• Proficient with MS Office, MS Project and other related software programs
• Advanced degree (M.S. or Ph.D.) in a relevant scientific field
• Ability to plan ahead and engage others to meet deliverables
• Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas

Assoc Scientific Medical Writer Resume Examples & Samples

• Act as the medical writing expert responsible for managing and editing study level documents (clinical study protocols and clinical study reports) in the area of Oncology
• Independently author parts of study level documents (collaborating with the team)
• Implement content strategy, project level data presentation and messaging standards as provided for the assigned documents
• Be accountable for the format, content and adherence to global and electronic publishing standards of the individual clinical documents
• M.Sc. or similar
• Two (2) years of experience in regulatory medical writing in the pharmaceutical industry
• Familiar with all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA)
• Basic understanding of the drug development process
• Working knowledge of the clinical study report and development process, regulatory and drug safety requirements, clinical data management as well as statistical processes/functions
• Strong communication skills in English, both written and verbal, to successfully articulate concepts and ideas
• Must be diplomatic, persuasive and able to establish rapport with all key functional interfaces and experts in the Oncology Development organization
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
• Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Other tasks as assigned
• Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint
• Experienced with scanners, printers, and copiers
• Writing effective branded and unbranded medical and CPG copy targeted to a consumer/patient audience
• Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, speaker videos, online graphic banner and text ads (multiple sizes), emails
• Collaborating in creative brainstorms, client status calls, and internal reviews with graphic designers, account and marketing managers, copywriters, editors, and others
• Providing vital support (including annotation work, if/when necessary) to a client services team that helps brand managers and their medical/legal/regulatory (MLR) teams steer all promotional pieces through review and approval processes
• BA/BS, preferably in a scientific, medical, or healthcare-related field
• Solid communication, client-facing, project/time management, and computer skills (MS Office Suite, Adobe Acrobat Pro, electronic workflow management systems, etc.)
• Ability to comprehend clinical information, branded master visual aids, and/or online interactive programs; science background a plus
• Demonstrated talent for teambuilding
• 2+ years’ relevant experience in a high-volume, online pharmaceutical advertising agency, medical education, or other healthcare communications writing role is preferred, but not required
• Bachelor's degree in a science-related field
• Prior experience within medical writing
• Prior experience in managing and directing complex medical writing projects
• Additional qualifications in medical writing (AMWA, RAC, etc) is advantageous
• Broad regulatory affairs experience is an advantage
• Advanced degree (PharmD, PhD, Masters) is preferred
• Suitable, relevant experience working in the pharmaceutical/CRO industry is preferred
• Excellent interpersonal skills including problem solving
• Advanced word processing, template and document management skills
• Excellent understanding of computers and their applications
• Attention to detail and quality of document
• Good and effective organizational and planning skills
• Self-motivated and adaptable
• Able to multitask
• Able to plan own work well in advance
• Able to work on own initiative
• Proven ability to work effectively in a team
• Able to teach/mentor team members
• Able to motivate and integrate teams
• Mental skills required in areas of: Numeracy, Language, Analytical, Investigative, verbal & written communication, Attention to detail, Customer contact, Multiple project handling, Reading and interpretation of data
• Excellent knowledge of Global Regulatory Affairs Procedures
• Good knowledge of global / regional / national document development requirements
• Excellent knowledge of relevant ICH and other global regulatory and document development guidelines
• Good in-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc
• Able to manage and plan multiple complex projects
• Able to direct the work of others
• Excellent judgment and decision-making skills
• Able to act as liaison with other Divisions where necessary (i.e., Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, Late Stage, etc)
• Knowledge of budgeting and forecasting

Healthcare Solutions Principal Amcp Medical Writer Resume Examples & Samples

• Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers
• Collaborate with therapeutic area leads to incorporate TA strategies, scientific platforms, value messages into AMCP dossier
• Collaborate with Global Medical Information to develop and/or edit responses to address specific unsolicited payer and health care provider requests for health outcome information
• Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and policies and procedures, and are used to appropriately respond to inquiries from payers and health care providers
• Provide medical writing support for multiple assets within a therapeutic area(s)
• Perform literature searches for drafting AMCP dossiers
• Understand, assimilate, and interpret sources of information with appropriate guidance/direction from team members. Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify the results are consistent with study data
• Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate
• Maintains awareness of current industry practices that pertain to Corporate Policies and Procedures. Must continually train/be compliant with all current industry and company requirements
• Complies with the reporting of adverse effects and product complaints to Pharmacovigilance and Surveillance
• As a member of staff, you will be expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
• You will independently write clinical study reports and other regulatory documents according to ICON or client-specified formats
• You will be responsible for writing patient narratives independently for serious adverse events and drop-outs due to non‑serious adverse events
• You will have to independently provide additional writing and editing services (e.g. for publications) as required
• You will need to Advise on the content and format requirements for clinical reports and regulatory documents
• You will be performing quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs
• You will independently interact with clients to obtain necessary and relevant information and deal with queries through effective decision making
• You will participate in non-project specific activities, including assistance in maintaining the medical writing work schedule
• You will participate in the training and supervision of new and junior medical writers
• Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format
• Participates on departmental initiatives
• Knowledge of team dynamics and ability to function as a team leaderPHYSICAL DEMANDS
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
• Carrying, handling and reaching for objects
• You will be responsible for developing clinical, regulatory and educational documents such as study reports, Instructions for Use, protocols, abstracts, manuscripts, posters, presentations and press releases
• The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines
• You develop content that meets the stated objectives of the project, is scientifically and medically accurate; and follows house style guides and procedures
• You work closely with R&D in order to deliver high-quality documents
• Be primary author for documents that are within scope, which includes, but is not limited to: clinical study protocols, ICF, CSR, IB, PBRER/DSUR, committee charters, sections for regulatory submissions, CMC – internal protocols and reports and manuscripts
• Establish a business process for liaising with other departments (including but not limited to Data Management, Program Heads, Regulatory, Safety) to gather data for the above mentioned reports
• Develop and maintain tracking for the above mentioned documents
• Develop and standardize templates used in the writing of Clinical and other submission documents
• Create and update SOPs as needed
• Assist in writing technical reports, regulatory briefing documents and other documents to support product development
• Establish a style guide
• Prepare presentations as needed
• Experience within a broad range of medical writing projects
• Good knowledge of global / regional Medical Writing / Regulatory Affairs for clinical trials, marketing authorization and late phase procedures
• Additional qualification in medical writing (e.g. American Medical Writers Association) is advantageous
• Proficiency with Microsoft Office, in particular Word, Excel and PowerPoint
• Write documents associated with the independent review including, but not limited to: independent review charters (IRC), reviewer manuals, imaging case report forms (CRFs)
• Lead the internal and external project team through the development of documents associated with the independent review
• Coordinate and conduct interdivisional team review and sign-off of document deliverables according to PAREXEL’s guidelines/SOPs, including distributing drafts, chairing round table meetings, incorporating revisions, and completing the sign-off procedures
• Meet client expectations by following any templates, style guides, or SOPs provided by the client for document development (within the appropriate regulatory guidelines)
• Regularly communicate project-related issues with the Manager, Medical Writing, and the project team, as appropriate
• Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
• Bachelor’s degree in Life Sciences/Health Related Sciences recommended
• Clinical research/medical writing experience and 1-3 years medical writing experience in a contract research organization, or 2-4 years of experience in a pharmaceutical or biotechnology firm, or equivalent
• Excellent written and oral communication and interpersonal skills
• Strong word processing and Microsoft Office Suite skills: advanced skills in Microsoft Word and proficiency in Excel and PowerPoint
• Excellent organizational skills to work with the vast array of information gathered during document development and to cope with rapidly changing information
• Knowledge of the drug development process essential
• Knowledge of GCP/ICH guidelines and the clinical trials process
• Build understanding of the literature and current medical opinion
• Support the teams regarding new clinical data or medical press coverage
• Plan and conduct of fair-balanced assessment of efficacy and safety data and provide advice on the best approach to drive brand growth
• Assist in registration and development of RB Global products globally
• Serve as a technical point of contact for governance activities and collaborate with cross-functional teams
• Provide medical support and oversight for promotional activities
• Support the writing, editing and reviewing of diverse Regulatory and Clinical Documents required for global RB product development and registration activities. These include but are not limited to: briefing documents, common technical document (CTD) clinical overviews and summaries, switch applications, integrated summaries of safety and efficacy, clinical evaluation reports and other Medical/Regulatory documents
• Edit and proof reading of text written by other team members and providing constructive feedback
• Help create and maintain audit system/trails of all document changes
• Prepare responses to Medical Information requests where appropriate
• This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries) documents and responses to Notified Bodies
• Post Market Surveillance activities (monthly literature review of our product)
• Scientific Writing e.g. abstracts, manuscripts, presentations
• Requires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical data
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content
• Reviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goals
• Expert knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices
• Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences
• Clinical, scientific or research background
• Ph.D./Pharm.D plus 3+ years of related pharmaceutical/medical device industry experience
• 2+ years relevant experience
• Demonstrated scientific writing ability
• Strong communication/presentation skills
• Works well in cross-functional teams and promotes team alignment
• Expert understanding of scientific or clinical research and the scientific method
• Ability to critically analyze and interpret scientific data
• Highly proficient in the use of Microsoft Office suite (Microsoft Word, PowerPoint, Excel), Adobe software (Photoshop, Illustrator), and EndNote Reference Software
• Adept in performing literature searches in Pubmed and other relevant platforms
• Understanding of statistical methods
• Can proactively and independently communicate throughout the organization
• Ability to adapt to changes rapidly in a fast-paced working environment
• Able to identify problems and propose potential solutions
• Ability to coordinate and prioritize multiple projects simultaneously with minimal supervision
• Can identify and lead departmental initiatives
• Bachelor's degree in a technical discipline
• 5+ years’ experience supporting clinical research and report writing or experience writing in a medical/scientific area
• Masters or PhD degree(s) in biomedical sciences or technical disciplines
• Medical device industry experience or related industry experience
• Direct experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical evaluation reports and post market surveillance reporting
• Computer skills (Microsoft Word, Excel and Project or equivalent)
• Database management experience in the Administrator capacity (Quosa, Microsoft Access or equivalent)
• Experience conducting literature searches and literature reviews
• Experience managing Endnote Libraries
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers
• Draft clinical & scientific documents including but not limited to, clinical evaluation reports, clinical risk benefit analysis, interim and final clinical study reports for the assigned projects
• Coordinate and manage review processes, revise the documents as per comments from internal & external reviewers, and lead discussions on document revision and finalization
• Conduct literature searches, manage the literature database and prepare literature reviews for external and internal clients
• Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
• Attend major national & international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution
• Develop and maintain SOPs and writing tools, such as templates and style manuals
• Advanced degree in a scientific discipline (Master's degree, Ph.D., MD) with 3+ years’ experience in the medical device/pharmaceutical field with an Advanced degree, or a minimum of 7 years with a Bachelor's degree
• Experience in the development of clinical, scientific, and regulatory documents
• Demonstrated ability to meet project goals within a matrix environment

Med Info & Medical Writer Positions for Med Device Professionals Resume Examples & Samples

• BA, BS, or BSN is required; advanced degree is preferred
• Minimum of 3 years of related job experience
• Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements
• Strong oral communication, presentation, project management and prioritization skills
• Excellent interpersonal relationships
• Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager)
• benefits to be received upon meeting eligibility requirements

Clinical Medical Writer Resume Examples & Samples

• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
• Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
• Works effectively with cross-functional groups within BioMarin
• At least 6 years of medical or scientific writing experience as a primary job responsibility, including at least 3 years as a clinical or regulatory medical writer in the pharmaceutical industry
• Familiarity with the drug development process (discovery to market), clinical study protocol design and study conduct, documentation required for the conduct of clinical studies, and clinical study data collection and results reporting
• Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documetns and templates
• Experience writing protocols and clinical study reports. Review and/or editing experience alone is not sufficient
• Ability to interpret and summarize tabular and graphical data presentations
• Proficient in the use of Windows-based office applications. Extensive experience in Microsoft Word (including the use of templates)
• Capable of working on multiple tasks and shifting priorities, and capable of leading cross-functional teams under strict timelines, including calling/running meetings and managing review/adjudication of documents
• At least 10 years of medical or scientific writing experience as a primary job responsibility, including at least 5 years as a clinical or regulatory medical writer in the pharmaceutical industry
• Experience writing BLA/MAA submissions (Module 2 and 5 documents), IND/CTA submissions, investigator's brochures, periodic safety reports, and informed consent documents
• Experience working with Adobe Acrobat (creating and editing PDF files). Experience with Acrobat Reader is not sufficient
• Intermediate/Advanced applied knowledge of AMA and Chicago Style Manuals
• Some knowledge of basic clinical laboratory tests, including their purpose in diagnosing disease
• Some knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports)
• Good conflict management skills, including ability to broker agreements between disagreeing parties
• Motivated and detail oriented
• Planning and coordination of timelines, meetings, and facilitation of cross-functional communication and contribution
• Assisting with responses to questions from regulatory authorities (eg, MAA and FDA)
• Contribute to regulatory submissions by authoring relevant sections of eCTDs (eg, ISS, Summary of Clinical Safety)
• Performing quality-checks of documents for agreement between in-text and source data
• Editorial review of documents, including submission-compliant formatting
• The candidate must be able to work independently and efficiently with cross‑functional team members. Reliance on instructions, templates, and pre-established SOPs and guidelines will be expected to perform the above functions
• Act as a member of clinical trial teams and submission teams and autonomously write/edit clinical study reports, CTD summary and overview documents, other regulatory documents (e.g. RMPs, Briefing books etc)
• Provide authoritative guidance to other line units and within RMW with respect to regulatory submission documents and other document-related issues
• As requested by RMW management, act as lead writer and co-ordinate production of documents by medical writing team in collaboration with clinical team
• Write/edit other strategic documents, as required, in collaboration with project teams and where necessary, with support from Senior Expert Medical Writers or RMW leadership team members
• Contribute to development of document templates and processes both within RMW and more widely
• Act as mentor to other medical writers
• At least 4 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge, plus strong knowledge of medical writing processes
• Ability to act as the editorial and scientific point of contact for multiple accounts in a variety of therapy areas
• Lead a variety of projects from client brief through to delivery on time and within budget
• Deliver high-quality educational and creative promotional materials
• Ensure materials are adapted to the briefed target audience
• Provide in-house editorial review of work undertaken by freelancers and junior writers
• Liaise directly with clients to fulfil their communication and marketing objectives
• Participate in client teleconferences and meetings as required
• Participate in the cross checking of editorial work written by other members of the writing team
• Support in winning new business through pitch research and presentation
• Taking the lead where appropriate in scientific and creative discussions around content
• Independently research and write sales aids, leave pieces, advertisements and training materials for pharmaceutical and device clients
• Ability to work on materials delivered via digital communications platforms in conjunction with the digital part of the business (idetails, apps, web copy)
• Previous experience of medical writing within an agency environment (1-2 years minimum)
• Able to seek out, critically appraise and appropriately cite published information
• Sound understanding of scientific/pharmacologic principles and mechanisms of action
• Experience writing web copy and promotional materials for pharmaceutical clients
• Sound knowledge of the codes of practice for the pharmaceutical industry
• Relevant Life Sciences qualification
• Responsible for writing up the final project deliverables. These deliverables will be concise and easy to read, incorporating the analysis plan, analytic results, and a review of the literature. The deliverables may be in the form of internal reports, slide decks, or peer reviewed publications
• Create abstracts, posters, and podium presentations for national conferences
• Report to the Senior Director, Advanced Analytics at Optum
• Post-graduate degree in a related field plus some relevant experience in the insurance industry
• 3+ years of experience in medical writing
• Able to understand and present data correctly, clearly, and concisely in a variety of media
• Knowledge of research / policy regarding the elderly and near elderly
• Able to work collaboratively as well as independently to produce high quality deliverables within specified timeframe
• Able to conduct multiple projects concurrently
• Proficiency with Microsoft Office applications essential
• Excellent writing and editing skills
• Outstanding analytic and problem-solving skills; demonstrated self-motivation, sound judgment, and attention to detail
• Graphic Design experience
• Provide medical/clinical expertise related to PD, HD, and/or CRRT therapies and related products including their clinical use and potential mis-use to internal cross functional teams
• Prepare clinical response to government authorities, in conjunction with regulatory and medical review, to ensure questions around renal therapy are interpreted correctly
• Develops clinical documents ensuring scientific excellence. The development process includes writing, interpreting and/or summarizing clinical and non-clinical data, compiling information, leading team meetings, and ensuring delivery within timelines. Clinical documents may include investigator brochures, clinical study reports, integrated reports, Clinical Investigation Reports, new product submissions. May also review case report forms and statistical analysis plans, product labels, and responses to regulatory agency inquiries
• Maintain current familiarity with the published medical literature related to the renal product lines so that information can be incorporated into various documents created within the organization in compliance with regulations around the world
• Possess and understanding and maintain current knowledge of regulatory and quality requirements
• Develop/review annual safety documents (such as PBRER, PSUR, CER, RMPs) and labeling products
• Responsible for the coordination, preparation and/or completion of clinical sections of renal therapy-related risk file updates, CCSI or label updates, and other documents as assigned
• Develop and review quality related documents as they pertain to our products
• Provide clinical support of complaint and adverse event analyses
• Assist Baxter's Regulatory Affairs by providing clinical input into the evaluation and response of Ministry of Health (MOH) queries
• Develop expert knowledge on all Baxter/Gambro Renal products
• Interface with other Baxter functional groups such as Medical Affairs, Regulatory Affairs, Quality, and global business units, as needed
• Work with team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted on time to regulatory authorities
• Lead or participate in project teams and committees as assigned
• Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable). Includes collaborating with medical editors to ensure documents are publication-ready across functional teams
• Serve as medical writing lead for clinical trial-related regulatory documents
• Write/edit/review content of clinical trial-associated documents for new and ongoing programs
• Work with cross-functional teams to ensure production of high-quality written documents
• Perform literature searches as needed, and summarize data for incorporation into documents
• Adhere to Kite Style Guide, templates, and SOPs for document development
• Perform QC checks on document content
• Commit to company timelines for all assigned documents

Scribe / Medical Writer Resume Examples & Samples

• Accommodates the needs of the patient for the exam
• At times, guides patient to front desk after completion of exam and ensures proper follow-up appointments are made
• Correctly summarizes and documents what the physician says during an examination, including but not limited to: proper charting of the examination, documenting additions to the chief complaint, assessment and recommendations for treatment (including justifications of decisions reached when appropriate)
• Enter charge information as designated by the physician
• Evaluates the condition of the exam room to ensure adequate supplies are in stock
• Learns the personality and preferences of each physician, recognizing differences and abiding by them when working with each particular physician
• Maintains an awareness of the patient�s verbal and non-verbal communication when the physician is providing instructions as it may necessitate the writer repeating information, providing written instructions, and/or patient educations materials for the patient to review at home
• Monitors examination room and any physical limitations that the patient may have
• Notifies physician of changes to the daily schedule, especially emergencies
• Performs other duties as assigned, including but not limited to, answering phones, scanning, abstracting, checking patients in and out, helping with work ques, etc
• Provides patient with assistants while they are exiting the exam room to expedite patient flow
• Remains as close to physician as possible and limits time away from the physician and the patient
• Fluency in English High School Diploma and four years experience in a medical office, medical transcription or billing/coding required Or Associates degree or equivalent and two years experience in a medical office, medical transcription or billing/coding required
• Basic of knowledge ICD-10 coding
• Act 33 Child Clearance with Renewal
• Act 34 Criminal Clearance with Renewal
• Act 73 FBI Clearance
• Basic Life Support or Cardio Pulmonary Resuscitation
• Work with lab members to draft and edit scientific articles and shepherd them to publication
• Assist in planning, writing, editing, and submission of grant proposals and progress reports
• Prepare scientific illustrations; assemble and organize data into figures for scientific presentations, publications, and grant applications
• Research and develop materials for presentations at scientific conferences, public outreach seminars, leadership meetings, and fundraising opportunities
• Attend meetings and manage scientific communications with collaborators
• Participate in weekly lab meetings and scientific discussions
• Other communications duties as required
• Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
• 3+ years of industry experience as Medical Writer
• Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus
• Experience in clinical documents related to late phase studies, IB, IND, Annual Reports
• Ability to work independently and collectively on teams
• Ability to plan ahead and engage others to meet deliverable
• Draft high-quality clinical & regulatory documents that demonstrate a good grasp of the scientific and medical content and drug development process with excellent understanding of data analysis, data management and regulatory submissions
• Work across departments to help set priorities for document preparation and collaborate on document content
• Coordinate and manage consulting writers as needed
• Work with service providers as needed for delivery of high quality documents
• Write clinical abstracts, posters, and manuscripts
• Review and edit documents prepared by other authors
• Maintain document history and manage version control of documents
• Provide guidance for style guides for document preparation
• Keep current with relevant therapeutic area(s)

Cr-medical Writer Resume Examples & Samples

• Writes and oversees the preparation of clinical study protocols, clinical study reports, Investigator’s Brochures, clinical pharmacology sections of US and EU clinical trial applications and marketing applications, and other high-level summary, briefing, and response documents in accordance with international guidelines
• Develops/Maintains standards and processes
• Follows Teva Safety, Health, and Environmental policies and procedures
• Working knowledge of regulatory document submission standards and guidance documents related to electronic documents for submissions
• Advanced Microsoft Word and Adobe Acrobat skills strongly preferred
• Experience with Documentum
• Previous use of ISI Toolbox
• One to three years of related experience
• ) Strong understanding of eCTD Clinical documents
• )Team Player
• ) ability to take direction and them work independently
• ) experience with documentum
• Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical
• Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals. Ensures all
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant
• Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience
• 4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D
• 2 years relevant industry experience preferred
• 4 years experience in experimental design and clinical/preclinical data interpretation preferred
• High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques
• Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations. Knowledge and expertise with Common Technical Document content templates. Expert knowledge of current electronic document management systems and information technology
• Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy
• Extensive experience in working with collaborative, cross-functional teams, including project management experience

Report Coordinator, / Medical Writer Resume Examples & Samples

• Must be highly proficient in Microsoft Word and Excel, and have excellent oral and written communication skills. Experience with other software applications such as Adobe Acrobat and MS Access are a plus
• The ability to multitask and manage a flexible project load is mandatory
• Strong interpersonal, time management and organizational skills are also required
• At the time of interview, an assessment of skills to determine levels of proficiency with Word, Excel and editing will be given
• Editing experience is a plus
• Write clinical study reports under supervision of more experienced writers
• Write patient narratives autonomously
• Quality check patient narratives written by other writers
• Write safety documents (e.g. RMP, DSUR) under supervision from more experienced medical writer
• Act as a member of clinical trial teams following protocol finalization
• Participate in planning of analysis and data presentation to be used in study reports, initially in conjunction with mentoring medical writer
• Preparation of narratives, clinical study reports and (as required) other regulatory documents with respect to timelines and compliance to internal and external standards
• Completion of an adequate number of clinical documents (taking into account complexity) per year
• Adequate representation of RMW in the clinical trial team
• Good document creation and editing skills
• Basic knowledge of clinical documentation
• Basic knowledge of drug development
• Taking and accurately interpreting briefs from clients and other members of the BioScience team
• Responsibility for the management and development of a range of editorial materials such as publications, meeting materials, slide kits and electronic materials, including researching, writing and editing, with little input from more senior members of the editorial team
• Delivery of materials within timelines and budgets, including problem solving
• Managing the development of the design process for editorial materials, in conjunction with account staff
• Provide direction for the development of creative designs
• Attendance at onsite meetings providing a variety of support, including slide reviews, faculty support, AV production and general assistance
• Being the day-to-day contact for clients in relation to specific medium to large sized editorial projects or editorial lead on small accounts that the writer is responsible for
• Implementation of specific client or in-house styles
• Contributing to the development of new business proposals and pitches, where appropriate
• Keeping abreast of new developments within the field of medical education and passing on of knowledge to the internal team and external clients, where appropriate
• Adherence to deadlines and budgets
• Life sciences qualification
• Demonstrable competence in scientific and commercial writing with ability to adapt to different target audiences and styles
• Previous experience of working within a Medical Communications agency or similar role
• Knowledge of publications planning and experience of writing manuscripts
• Attention to detail and scientific accuracy
• Excellent time management and project organisational skills
• Ability to adapt quickly to a wide range of therapy areas
• Proficiency in Microsoft Word and PowerPoint. Previous experience of referencing software is preferable
• Minimum of a BA/BS in Life Science
• 3-5 years pharmaceutical/biotechnology experience related to clinical research
• Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally Ability to interpret and organize scientific and clinical data
• 3+ years medical writing experience in Pharma, Biotech and/or CRO, necessary
• Experience with ICH and electronic submission guidelines for regulatory reports
• Good leadership, communication, and influencing skills
• Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
• Ability to manage change successfully and identify process improvements
• Applies good judgment and demonstrates initiative to resolve issues
• Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)
• Ability to enact change and foster an innovative atmosphere
• Write clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision
• Write, review, and/or edit publications (manuscripts, abstracts, poster presentations, etc.)
• Drive document writing and review processes
• Develop and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
• Coordinate and manage review cycles, incorporates team comments, and lead discussions on document revision and finalization
• Must have excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data
• Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals
• Provide training on medical writing templates, SOPs, and processes within the department and across departments
• Contribute to the development of electronic document systems and tool
• Provide quality control (QC) review of various regulatory and medical communications documents
• Provide project team(s) with guidance and problem resolution related to document generation
• Bachelor’s degree in a life sciences discipline and a minimum of 3-5 years biopharmaceutical industry experience, or a masters/PhD degree in a life sciences discipline and a minimum of 3 years biopharmaceutical industry experience
• Minimum of 2 years Oncology Medical Writing experience
• Experience preparing clinical regulatory documents and scientific publications are crucial
• Prior NDA/BLA/MAA submission experience, including eCTD, is preferred
• The candidate must have an in depth understanding of all regulatory guidance’s, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA)
• The candidate must have experience in electronic document management and electronic regulatory submissions, tools and standards
• The candidate must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas in cross functional team settings
• Minimum of 5 years direct CRO/pharma experience preferred, preferably in the assigned TA area
• Medical writing experience in the TA area of expertise
• Demonstrated computer skills – requires excellent MS Office experience (specifically Excel, Word, Outlook, Powerpoint)

Global Medical Writer Associate Resume Examples & Samples

• Provide input and edit/review Clinical documents such as Study Protocols, Investigator’s Brochures and Informed Consent Forms
• Review, improve and maintain existing documentation; prepare responses to Medical Information requests where appropriate
• Systematic literature searches/reviews as necessary
• Understand clinical and medical data for the product and competitors, provide the team with innovative stimulus about the product portfolio
• Act as a member of clinical trial teams and submission teams and autonomously write/edit clinical study reports, CTD summary and overview documents, and other regulatory documents
• Provide authoritative guidance to other line units and within DE with respect to regulatory submission documents and other document-related issues
• As requested by DE management, act as lead writer on submissions and co-ordinate production of summary documents by medical writing team in collaboration with clinical team
• Write/edit other strategic documents, as required, in collaboration with project teams and where necessary, with support from Senior Expert Medical Writers or DE leadership team members
• Participate in planning of analysis and data presentation to be used in clinical programs, individual study reports or summary documents
• Act as project medical writer for complex submission programs in clinical development
• Contribute to development of document templates and processes both within DE and more widely
• Serves as medical writing lead on clinical regulatory documents. Works closely with the Clinical and Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and OUS)
• Converts relevant data and information into a form that meets clinical regulatory document requirements and procedures. Explains data in manner consistent with clinical regulatory requirements
• Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level Manages processes for obtaining feedback for improvements for the documents. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate
• Understands/complies with appropriate conventions and style guides, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs
• Knowledgeable of US and international regulations (e.g. MEDDEV Revision 4), requirements and guidance associated with clinical regulatory document preparation and submissions. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards
• Master’s degree
• 5+ year's industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D
• Experience with FDA and international regulations (device, e.g., 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155, MEDDEV, EU MDR)
• Knowledge of ISO 14971, AIMDD, MDD, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements
• 5+ years’ experience in investigational design and clinical/preclinical data interpretation preferred
• Program/project management skills and demonstrated experience leading project teams
• Knowledge and experience with Design History File, Technical File, Design Dossier, Clinical Study Report, Clinical Evaluation Report content templates. Working knowledge of current electronic document management systems and information technology
• Ability to assimilate and interpret scientific content and translate information for appropriate audience
• Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy
• Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment
• Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet in a network environment
• Demonstration of self-motivation and leadership skills
• Capable of performing work remotely
• Able to manage complex tasks
• Good understanding of statistical methods
• Serves as medical writing lead on assigned clinical regulatory documents. Works closely with the Clinical and Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and OUS)
• Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory reports and deliverables. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents
• Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases)
• Bachelor of Science required,
• 3+ year's industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/ R&D
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices
• 3 years’ experience in investigational design and clinical/preclinical data interpretation preferred
• Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation, submissions, and reporting
• Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience
• Excellent written and oral communication skills and ability to interface professionally and diplomatically throughout all levels of the organization
• Ability to work with international teams
• Ability to manage time efficiently and prioritize tasks
• Ability to prioritize tasks using a risk based approach
• Strong interpersonal skills, ability to work with teams and be a self-initiator
• 4+ years of experience supporting industry-sponsored clinical research and/or 2+ years supporting medical/scientific publications
• Experience in development and preparation of manuscripts in scientific formats
• Strong knowledge of AdvaMed guidelines and Code of Ethics, CONSORT, ICJME, ISMPP code of ethics and the COPE Code of Conduct
• Significant knowledge of clinical and outcomes research study design
• Familiar with medical device and/or combination product trials and regulations
• Strong knowledge-base in areas of cardiovascular and/or structural heart pathophysiology and therapy
• Necessary bibliographic background research
• Writing materials
• Providing full reference sets
• Incorporating all feedback provided by the client in a proper and timely manner
• A minimum of 5 years of medical writing experience
• Experience in mentoring Junior Medical Writers/ Medical Writers
• Produce a full range of written communication in accordance with the needs of the customer and organization with considerations for the target audience, target publication (including adherence to formatting guidelines), publication medium, and level of design/creativity
• Manage the publication effort through medical writing of meeting abstracts and presentations, corporate white papers and reports, and journal manuscripts. Lead team to ensure adherence to submission and company-driven deadlines
• Contribute to and collaborate on statistical analyses and data quality checks for complete results interpretation and to ensure the delivery of accurate and relevant output, demonstrating advanced problem solving ability
• Achieve editorial excellence, producing clear, accurate, grammatically correct, and creatively written work for a variety of audiences
• Proactively communicate, as the primary liaison, with all relevant parties and manage projects to external and internal timelines and deadlines
• Demonstrate a high level of product and procedure knowledge to support research-related questions and independently provide internal/external training as necessary
• Provide training, mentorship, and guidance for junior team members in all aspects of data management, analysis, scientific writing, and utility of literature resources
• Develop and implement corporate procedures for medical writing
• Assist research and other project team members in additional responsibilities as required
• Bachelor’s degree in Life Science, Biological Science, or related discipline
• 2+ years of experience as a medical writer in a healthcare-related field/industry
• Strong understanding and comprehension of medical terminology
• Proven experience of basic post-market project management, data management, data analysis, and advanced medical writing techniques
• Required: Strong proficiency with Endnote (or equivalent), MS Office (Word, Excel, Access, PowerPoint), scientific search engines (PubMed, Google Scholar), image production software (Photoshop), and online journal/conference submission systems
• Graduate degree
• Experience in a clinical or industry setting with study experience focused on Spine, Orthopedics, or Medical Devices
• Working knowledge of statistical analysis software (SAS, SPSS, JMP, R, or equivalent) and diagnostic image analysis software (PACS) preferred

Associate Principal Medical Writer Resume Examples & Samples

• Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision
• Represents department on clinical teams (e.g., study management teams, clinical development teams); leads document-related meetings; reviews statistical analysis plans and clinical data reports as needed
• 2+ yrs regulatory writing experience, consistently produces medical writing deliverables for clinical program(s)
• Work closely with external authors and internal cross-functional areas to develop high-quality manuscripts and review articles for peer-reviewed journals as well as abstracts, posters, and slide presentations for scientific congresses and internal use
• Assist in publication plans and strategic direction for scientific congress planning teams
• Liaise as needed with medical directors, biostatisticians, safety experts, and health economists as well as external opinion leaders, investigators, authors and journal editors
• May prepare/edit standard response letters and FAQ’s and acts as lead in the development and updating of these documents
• Oversee the work of freelancers and vendors
• Perform QC review of existing documents or parts of documents
• Develops strong internal relationships with the R&D organization
• Keeps abreast of current data, trends, medical knowledge, developments and advances in the Pain Therapy space
• MS, PHD, PharmD or MD degree
• Minimum 3 years relevant medical writing experience, focused on publications, for a biotech/pharmaceutical, medical communications agency or CRO
• Experience in CNS and/or Pain Therapy areas a plus

Entry Level Medical Writer Resume Examples & Samples

• Write clinical study reports, protocols, clinical development plans, FDA briefing documents, and IND, NDA, and MAA modules
• Coordinate quality control reviews of documents and maintaining audit trails of changes; and
• Provide input on data analysis planning and interpretation
• Degree in a life science or engineering field (PhD preferred)
• Prior experience in the research, pharmaceutical, or medical device industry preferred
• Strong computer skills, project management skills, and a high attention to detail; and
• Strong communication skills (both written and oral)
• Regulatory Writing
• Clinical Submissions
• Pharmaceutical Industry

Medical Device, Medical Writer Resume Examples & Samples

• Acts as Lead Medical Writer on more advanced writing projects and performs competently, with guidance from senior staff
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and
• Good understanding of common statistical methods used in clinical trials and interpretation of their results
• Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned
• Ability to identify deficiencies, errors, and inconsistencies in a protocol
• Ability to identify deficiencies, errors, and inconsistencies in statistical output
• Confidence in building relationship with customer and discussing Mediacl Writing issues with customers in person or on
• Bachelor's degree in a life science-related discipline, plus 2.5 years' experience as a medical writer within a
• Write clinical documents including protocols, IBs, CSRs, patient narratives
• Write regulatory documents including INDs, eCTD/NDAs (including ISS and ISE summaries), Advisory Committee presentations, and briefing books
• Prepare scientific literature searches, abstracts, posters, and manuscripts
• Analyze and interpret clinical study data
• Ability and willingness to assist with Quality Control of documents produced within Adverum
• Lead document review and comment resolution meetings with cross-functional teams
• Ability to work closely with other writers and provide Quality Control of documents
• Skilled at data analysis
• Able to build and maintain effective partnerships
• Strong organizational abilities
• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive goals
• Dedicated to producing high-quality documents
• Ability to work in a collaborative and multi‐disciplinary environment
• Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents
• Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, and regulatory strategies
• Experience working on NDAs, BLAs, and other submission activities
• Experience mentoring/training other writers
• Exceptional oral and written communication skills
• Strong understanding of drug development, clinical study design, regulations and scientific principles
• Able to manage time and expectations in a small group setting with limited/no administrative support
• Excellent computer skills (Microsoft Office Suite) with advanced proficiency in MS Office (Word, Excel, and Outlook) required
• Quickly learn and become proficient with the BioPharm process for developing content
• Understand medical-marketing strategies and content objectives for assigned accounts
• Develop content that meets the stated objectives of the project, is within job specifications as defined by team/client, follows technical specifications, and is scientifically and medically accurate
• Determine adequacy of references provided for projects and secure additional references or information as necessary
• Accurately cite from references and appropriately underscore (or highlight) these references for medical/regulatory review
• Address and incorporate edits requested by clients and KOL, as well as internal reviewers
• Consistently deliver high-quality materials on time and on budget, working closely with cross-functional teams
• Continually communicate project status to internal stakeholders through various formal and informal mechanisms
• Attend kickoff, status, and other job-related meetings
• Incorporate client changes and work with the team to address medical-legal review feedback
• Strong medical writing skills (including appropriate annotations) for development of manuscripts in prose and power point slides with graphics
• 2+ years of experience as a medical communications medical writer
• Solid understanding of bio-pharmaceutical industry including familiarity with the promotional review process
• Ability to quickly learn new medical/marketing subject matter and correctly interpret medical data
• Bachelor’s degree is mandatory, Master’s degree in science or higher required. PhD/PharmD preferred
• High level of attention to detail to ensure accuracy with medical content, including referencing
• Successful track-record of meeting deadlines while managing multiple projects simultaneously
• Excellent oral communication skills with clients, KOLs, and BioPharm team members, as well as strong listening and analytical skills
• Write intelligent, creative and engaging copy – whether subject lines, website copy or email layouts
• Portfolio containing work samples that demonstrate creative thinking and exceptional writing skills
• Able to multitask in a fast paced environment while functioning as a member of a highly collaborative team

Related Job Titles

Medical Writer Resume Sample

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Work Experience

• Mentors and leads less experienced medical writers on complex projects, as necessary
• Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas
• Experience of coordinating writing activities for regulatory submissions
• Plan, write, edit, review and coordinate the publication of scientific data through peer-reviewed journals and forums and/or regulatory documents
• Facilitate trial development and product registration
• Ensure and coordinate quality checks for accuracy, collates reviewer’s comments, adjusts content of document as required based on internal/external input, and prepares final version
• Exhibit flexibility in moving across development and preparation of multiple document types
• Excellent customer service skills and strong oral communication skills
• Prioritize multiple tasks and transition between activities depending upon corporate needs
• Proficiency in Microsoft Word and Outlook, familiarity with Microsoft Excel
• Perform all essential job functions under the constraint of tight timelines
• Demonstrated ability to communicate and write English clearly, concisely, and effectively
• Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
• Recent and significant experience in writing of regulatory documents such as Clinical Study Reports, Protocols, Summaries, Overviews
• Aptitude for compilation, analysis, and presentation of data
• Independently motivated with good problem-solving ability
• Work with teams to ensure smooth and timely development of documents
• Influence or negotiate change of timelines and content with other team members
• Effectively collect and evaluate information from multiple sources
• Five years of experience as a medical writer in a medical education company
• Excellent writing skills for professional and patient education materials and able to write medical documents independently
• Perform medical literature research and interpret medical literature independently
• Knowledge of medicine and disease states
• Comprehensive understanding of ACCME guidelines
• Strong familiarity with medical terminology

Professional Skills

• Excellent written and oral communication skills. Experience in working working collaborative, cross-functional teams, including project management experience
• Demonstrated experience in clinical development, strong interpersonal, time management, project management, and technical writing skills highly desirable
• Demonstrated advanced writing skills , with strong command of English language and grammar
• Experience working in collaborative, cross-functional team environments; strong project management skills
• Proven administrative and organizational skills, good computer literacy and experience
• Experience working with standard document templates/styles to support electronic (eCTD) submissions; strong MS word formatting skills
• Demonstrated ability to meet project goals within a matrix environment; excellent project management and organizational skills

How to write Medical Writer Resume

Medical Writer role is responsible for interpersonal, medical, scientific, organizational, clinical, word, technical, microsoft, adobe, editing. To write great resume for medical writer job, your resume must include:

• Your contact information
• Work experience
• Skill listing

Contact Information For Medical Writer Resume

The section contact information is important in your medical writer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

• First and last name
• Telephone number

Work Experience in Your Medical Writer Resume

The section work experience is an essential part of your medical writer resume. It’s the one thing the recruiter really cares about and pays the most attention to. This section, however, is not just a list of your previous medical writer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular medical writer position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Medical Writer resume experience can include:

• Excellent written and verbal communication skills, data-interpretation skills, strong interpersonal skills, ability to plan and organize
• Excellent written and verbal communication skills and effective interpersonal skills
• Strong technical and scientific skills and the ability to effectively communicate these aspects in writing
• Demonstrate problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers
• + Excellent writing and editing skills, and a keen attention to detail
• Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat

Education on a Medical Writer Resume

Make sure to make education a priority on your medical writer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your medical writer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

• School you graduated from
• Major/ minor
• Year of graduation
• Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Medical Writer Resume

When listing skills on your medical writer resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical medical writer skills:

• Good interpersonal skills and the ability to operate effectively in an international environment
• Strong scientific/medical writing skills evidenced by good quality writing of Medical Affairs communications and/or publications in peer-reviewed journals
• Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach
• Strong project management and organisational skills combined with good understanding of the commercial drivers of the business
• Strong influencing skills in shaping and developing content and wording; able to lead without formal authority
• Excellent writing, proofing, and copy editing skills

List of Typical Experience For a Medical Writer Resume

Experience for senior medical writer resume.

• Excellent editorial (editing and writing) skills, preferably in the area of grant/proposal and manuscript development
• Good organizational/planning and problem-solving skills at the document level
• Maintain ability to work effectively in a fast-paced environment with multiple high-priority projects
• Experience supporting clinical research and report writing or experience writing in a medical/scientific area
• Document organization, management, and version control skills to include hyperlinking, TOC generation, and field updating
• Strong reviewing/coaching experience in a medical communications agency
• Use project management principles to communicate effectively (written and verbal) within the Integrated Product Team (IPT) development framework
• Basic document preparation skills and capability in the use of relevant software applications, templates, and other electronic formats

Experience For Principal Medical Writer Resume

• Solid knowledge of the clinical development process and Good Clinical Practices
• Impeccable communication skills - both written and oral
• Writing effective promotional copy for digital campaigns (branded and unbranded) targeted to a physician/healthcare professional (HCP) audience
• The applicant is desired to have experience in writing and reviewing standard operating procedures
• Clinical research/medical writing experience including writing multiple clinical study reports, and either CTD documents or similar, or study protocols
• Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting

Experience For Associate Medical Writer Resume

• Adept at researching, compiling, and analyzing clinical and scientific evidence quickly
• Ideally, 4 years’ experience in medical writing, including 2 years as medical writing project lead
• Oncology-focused medical/scientific writing experience in an academic or agency setting
• Extensive experience in writing and reviewing Clinical Evaluation Reports
• Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence
• Experience in technical writing in a regulated commercial setting (CRO/biotech industry), preferably medical devices/ IVD diagnostics
• Medical writing experience in a pharmaceutical/biotechnology or CRO setting

Experience For Lead Medical Writer Resume

• 3 – 6 years experience working within the biomedical and clinical writing field
• Proven ability to write clinically sound, balanced copy with marketing finesse, via writing sample
• Proven track record in writing and publishing clinical papers/abstracts
• Relevant experience in medical and healthcare writing / editing
• Clinical trial results presentations for distribution to clinical investigators – contribution to the good working relationship with investigators
• Experience writing about complex topics for professional audiences
• Experience writing about science/medicine for multiple (primarily lay) audiences
• + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment

Experience For Safety Medical Writer Resume

• Independently interact with clients to obtain necessary and relevant information, and deal with queries through effective decision making.
• Prioritize workload and to make strategic decisions about what to accomplish when faced with competing needs
• Participating in Clinical Project Management Training activities, including creating/reviewing training modules
• Drafting of SRLs (including the PML safety update) – create/update SRLs as needed, formatting new content according to approved templates
• Delivering quality editorial content to meet customer requirements – including reviewing and editing work to ensure quality standards are sustained
• Writing, editing and reviewing Risk Benefit Analysis

Experience For Clinical Research Medical Writer Resume

• Writing and reviewing Standard Opeating Procedures
• Advising and mentoring colleagues and clients on medical writing-related issues
• Editing and proofreading (specializing in medical content)
• Reading and summarizing medical literature in the context of preparing peer reviewed journal publications
• Understanding of medical-marketing strategies including familiarity with the promotional review process

Experience For Clinical Medical Writer Resume

• Preparing data tables including completing basic statistical analysis in table generation programs
• Understanding of global regulatory agencies and regulatory processes concerning medical devices
• Working knowledge of current electronic authoring, document management and electronic regulatory submissions
• Preparing the study report using details described in the protocol and protocol
• Working knowledge of MS Office suite and referencing software (ie, Endnote, Refman, etc.)
• Providing guidance to assigned Project Teams and Project Team members
• Providing language updates, as required, for all MedComm document templates as needed
• Updating department SOPs and Work Instructions as needed
• Leading the MW activities for assigned project(s) including writing key deliverables

Experience For Scribe / Medical Writer Resume

• Leading or participating on non-project related initiatives
• Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs
• Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled
• Ensuring that records are filed in accordance with site procedures
• Generate original text and materials by collecting, organizing, interpreting and classifying information for research and reporting purposes
• Responsible for executing literature searches and for reading, analysing and summarizing medical literature
• Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
• Assist in growing and managing the CRD/MW resources including relevant literature, example documents, style guides, and templates

Experience For Senior Medical Writer / Project Manager Resume

• Flexibility in meeting challenging deadlines and changing requirements
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Provides writing and editing support to colleagues during manuscript preparation and submission
• Conform to house styles and processes (including project tracking, timekeeping)
• Expertise in copyediting, science and technical writing and writing for the media
• Support cross-functional coaching, mentoring, and training
• Perform quality control review such as copy editing, content editing, and number checking for other Medical Writers as required
• To embrace and promote to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Team Building - Team focused. Encourages and sets an example for cooperation, creating trust and working toward common goals and values

Experience For Contract Medical Writer Resume

• Liaise with Senior and Scientific Services Directors on junior writers’ training needs and provide coaching and mentoring as required
• Function as a key contributor in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
• Remain scientifically current in assigned therapeutic areas, including understanding important clinical issues and industry trends
• Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs
• Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts
• Knowledge of global post marketing safety reporting regulations and guidance’s

List of Typical Skills For a Medical Writer Resume

Skills for senior medical writer resume.

• Strong written and oral communication skills, including solid interpersonal skills that enable positive influencing of others
• Excellent verbal and written communication skills and be able to demonstrate a high level of accuracy and attention to detail
• Strong project management and organizational skills and proven ability to meet timelines
• Experience with effectively managing vendors and contract writers to meet timelines/project objectives
• Dynamic, self-starter with strong influencing skills and adaptable to change
• Good problem-solving and analytical skills. Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project
• Strong organizational and meeting skills
• Excellent oral communication skills with clients, physician experts, and agency team members

Skills For Principal Medical Writer Resume

• Strong client management, project management and team leadership skills
• Excellent interpersonal and team-oriented skills
• Excellent project/time management and organizational skills to handle multiple tasks and meet deadlines while delivering high quality work
• Good interpersonal skills with confidence in managing physicians/clients/authors
• Excellent project/time management and organizational skills and ability to work on own initiative
• Strong computer skills and general computer literacy
• Excellent communication skills (English language; written and verbal)
• Excellent grammatical and communication skills, both written and oral
• Proven organisation/time management skills and the ability to be proactive and use your initiative to get results

Skills For Associate Medical Writer Resume

• Strong communication skills, proficient command of the English language in both oral and written format, and action orientation to address issues
• Good interpersonal skills and relates well to both client and internal personnel
• Apply critical thinking and problem solving skills and use logic and reasoning to support recommendations to the project team
• Advanced scientific reading, writing, and editing skills
• Demonstrated experience in identifying new business opportunities for both new and existing clients
• 3+ yrs regulatory writing experience; Proven record of success in contributing to clinical development programs and submissions
• Strong ability to manage timelines and assist in driving documents towards completion amongst colleagues with competing priorities
• Effectively manage medical writing projects to deliver quality products in agreed upon timelines

Skills For Lead Medical Writer Resume

• Up to 3-5 years of experience in scientific/medical writing, preferably experience with medical devices
• Proven track record of scientific writing along with a strong scientific background
• Experience in clinical/pharmaceutical development with directly related medical writing experience
• Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Has used 1 or more EDM systems
• Extensive clinical regulatory writing skills
• Extensive progressive experience in medical and/or scientific writing or equivalent education and experience

Skills For Safety Medical Writer Resume

• Advanced writing competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are essential
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat
• Skilled with software applications and document management systems, including experience with document templates
• Prior medical information and/or medical writing experience
• Exceptional organizational and project planning skills
• Experience in medical writing, preferably experience with medical devices

Skills For Clinical Research Medical Writer Resume

• Proven experience in the preparation of message-driven market access materials including value dossiers, and HTAs is preferable
• Clinical experience with 5+ years of relevant medical writing experience in biotech, pharmaceutical or clinical research organization
• Manage/prioritize multiple projects, working in a fast-paced environment. Flexible/willing to adapt to changing deadlines and priorities
• At Lead Medical Writer level: Ability to effectively communicate in oral presentations
• Superior language and communication skills with the abilitiy to translate complex scientfic materials into various formats efficiently
• ≥7 years of solid experience in clinical submission

Skills For Clinical Medical Writer Resume

• Medical writing experience in a medical communications agency or equivalent combination of education, training and experience
• Proficient computer and word processing skills
• Skilled with MS Word and competent in MS Excel and the use of bibliography databases. Experience with Document Management systems
• High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required
• Prior related experience with a B.S. or less than 3 years with M.S
• Proven experience in medical devices
• Proven experience of the scientific peer review process
• Effectively manages medical writing projects to deliver quality products in agreed timelines

Skills For Scribe / Medical Writer Resume

• Works effectively with colleagues from other departments in team situations
• Proven writing experience in a medical communications agency or the pharmaceutical/healthcare industry
• Proven experience and confident in interacting with clients and medical experts, flexible and able to work as part of a team
• Proven to have extensive writing experience in a medical communications agency or the pharmaceutical/healthcare industry
• Prior experience within medical writing is advantageous
• Excellent time and priority management, work efficiently under pressure
• Writing effective and compelling case study content targeted to a physician/ healthcare professional (HCP) audience across various therapeutic categories
• Writing effective branded and unbranded promotional copy targeted to a world-wide physician/healthcare professional (HCP) audience

Skills For Senior Medical Writer / Project Manager Resume

• Training and development of less experienced Medical Writers
• Creating Final Effective documents
• ≥2 years of experience with scientific research methodology, including designing and conducting experiments, and analyzing and reporting experimental results
• Previous experience leading and writing submission-level documents, including familiarity with eCTD format and associated guidance
• Significant experience designing, writing, and editing clinical content for healthcare professionals
• Experience in managing and directing medical writing projects
• Skilled at reviewing and editing the work of others
• > 6 months of experience training or providing constructive feedback on editorial production
• Experience with analyzing and summarizing scientific data in medical device

Skills For Contract Medical Writer Resume

• Experience of managing junior Medical Writers/Editors, and reviewing their documentation
• Experience writing for and submitting to medical/clinical peer reviewed journals
• 6 – 8 years experience working within the biomedical and clinical writing field
• Extensive experience in scientific/medical writing, including translations (mainly from English to Japanese)
• Experience with submitting and working with medical journals
• Solid understanding of the clinical development process, including the documents that are required at each stage
• Experience writing and editing clinical regulatory documents
• Demonstrated high attention to detail, including capacity to catch and resolve issues not caught by more junior level quality checking

List of Typical Responsibilities For a Medical Writer Resume

Responsibilities for senior medical writer resume.

• With minimal support, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, Module 2 summary documents, and other IND/CTA or global regulatory submission documents
• Contribute to account plans, strategic publication plans and publication programs, where appropriate, by maintaining current awareness of developments in therapeutic area or discipline and the Springer Healthcare product portfolio
• Present to clients the results of activities, when required, e.g. publication plans, results of competitive intelligence reports, and to contribute to client brainstorming meetings
• Ensure that projects reflect a thorough understanding of clients’ objectives Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
• Excellent interpersonal skills, analytical and critical thinking

Responsibilities For Principal Medical Writer Resume

• Effectively manage all assigned publication projects, including projects outsourced to vendors
• Excellent medical writing capability including writing for an end-user audience
• ≥ BA/BS and ≥ 5 years’ experience writing a broad range of clinical regulatory documents
• Solid understanding of FDA regulations and ICH/GCP guidelines
• Establish and maintain effective working relationships with supervisor and colleagues
• ≥ BA/BS and ≥ 10 years’ experience writing a broad range of clinical regulatory documents
• Experience working with content management processes and best practices
• Helps Clinical Sciences, Medical Affairs, Study Management, and Marketing to devise and implement an effective publication strategy

Responsibilities For Associate Medical Writer Resume

• Experience in scientific/medical writing
• Related industry experience (e.g., medical writing, scientific publications, clinical research)
• PhD with at least 6 years experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry
• Experience working with pharmaceutical/healthcare industry or academic institution
• Experience preparing scientific publications (abstracts, posters, manuscripts)
• Experience with submitting to major medical journals (NEJM, Lancet, etc)
• PhD in the Life Sciences with at least 6 years experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry

Responsibilities For Lead Medical Writer Resume

• Excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP)
• Medical/scientific writing experience in the pharmaceutical/healthcare industry, academia, or other relevant industry
• Solid understanding of therapeutic area(s)
• Solid understanding of standard clinical document types
• Solid understanding of internal and external guidelines related to document preparation
• Desired experience in scientific literature (participation or leading scientific paper publications)
• Strong neurology/neuroscience background, ideally including MS
• Experience with a broad range of various clinical submission tasks including regulatory documents and publications
• Maintain current awareness of good-publication practices and editorial policies and apply to publishing projects

Responsibilities For Safety Medical Writer Resume

• Regulatory medical writing experience
• Medical or scientific writing experience as a primary job responsibility
• Proofreading and editing of written material
• Briefing document for the Phase III trial in relapsed refractory multiple myeloma
• Understanding of human anatomy, physiology, scientific and clinical research methods
• Willing to take on any task, no matter how small
• Understanding of the benefits and limitations of different data sources (ie, abstracts vs publications, primary vs tertiary data)
• Assists in planning and coordinating report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects

Responsibilities For Clinical Research Medical Writer Resume

• 85%: Leading the MW activities for assigned project(s) including writing key deliverables
• Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule.
• Conducts proofreading, editing, document formatting, reviewer comments integration and document completion / approval activities
• Bilingual English and one other European language (reading, writing, and speaking in a professional medical communications capacity)

Responsibilities For Clinical Medical Writer Resume

• Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards
• 15%: Leading or participating on non-project related initiatives
• Responsible for developing scientific projects and content as assigned. This includes writing or editing of pharma training materials, eLearning content, video scripts, magazine articles, and slide presentations across several therapeutic areas
• Work with Client Services team to respond to RFPs or other business development opportunities, including researching therapeutic areas, proposing curricula, and participating in pitches
• Work alongside our Instructional Designer to edit or write scientific copy as needed to an appropriate reading and literacy level for a variety of audiences, including scientific liaisons, healthcare professionals, and pharmaceutical representatives
• Manage external medical writers or thought leader contributors to ensure that content developed is of the highest editorial quality, and in alignment with client expectations and medical/legal/regulatory requirements and processes
• Independently provide additional writing and editing services (e.g. for publications) as required.
• In accordance with authors’ direction, provides medical writing and editing expertise for abstracts, posters, oral presentations, and manuscripts

Responsibilities For Scribe / Medical Writer Resume

• Compiles, writes, and edits medical writing deliverables, covering all phases of clinical research and in various therapeutic areas
• Develop literature analysis, scientific messaging, publication strategy, and hold publication planning meetings
• Responsible for developing high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products
• Competent in searching and synthesizing medical literature relevant to publication projects
• Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring it back on track with minimal fuss
• Provide appropriate input on others’ documents, including review of key contributing documents, such as the SAP
• Ensure that projects reflect a thorough understanding of clients’ objectives

Responsibilities For Senior Medical Writer / Project Manager Resume

• With support from senior level writers and/or Medical Writing Group Lead, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, and other IND/CTA or global regulatory submission documents
• Arrange and conduct review meetings with teams and independently resolves document content issues and questions arising from the writing/review process
• Represent Medical Writing on project teams
• Develop timelines and communicate writing process and timelines to team members
• Development and updating of Investigator’s Brochures, Safety Update Reports, and other regulatory documents.
• Independently write clinical study reports and other regulatory documents according to ICON or client-specified formats.
• Be responsible for the daily management of assigned medical writing projects.
• Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems).

Responsibilities For Contract Medical Writer Resume

• Participate in the training and supervision of new and junior medical writers.
• Represent Medical Writing at internal and external meetings.
• Plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs
• Expertise in searching medical literature and databases for clinical and technical information
• Oversees internal quality review processes, including senior scientific review, data verification, and editorial review
• Upholds industry publication standards, including ICMJE recommendations and GPP3 practices
• Support a diverse group of internal and external stakeholders and adapt working style to accommodate a variety of personalities and needs
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency
• Develops and maintains tools to track document status to ensure reporting requirements are met

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10 Best Resume Builders to Create A Great Resume – 2024 Guide

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10 Best Resume Writing Services

• Super Star Resume - Best overall
• ZipJob - Best for guarantees
• Resumeble - Best with custom bundles
• Let’s Eat, Grandma - Best for range of career service
• ResumeSpice - Best for job seekers of any level
• TopResume - Best customer service
• Resume Writing Services - Best for affordability
• Craft Resumes - Best for quick turnaround
• Resume Companion - Best value resume writing service
• Resume.com - Best free service

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Super Star Resume - Best Resume Builder Overall

Star Rating: 4.9/5

Super Star Resume is an innovative resume builder that completely transforms creating professional resumes. By offering a user-friendly interface and a range of powerful features, Super Star Resume enables individuals to produce exceptional resumes that effectively showcase their abilities, accomplishments, and work history.

• Skilled and seasoned writers
• Customized strategy aligned with unique career objectives
• Timely delivery of resumes
• More significant expense compared to certain other resume writing services
• Restricted selection of additional services
• Availability may be restricted depending on demand and geographic location
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• Professional Resume : $169
• Resume With Cover Letter : $199
• All-Included : $199

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ZipJob - Best Resume Builder for Guarantees

Star Rating: 4.7/5

ZipJob is widely regarded as an excellent option for resume creation, especially for those who value guarantees. Their impressive 60-day assurance ensures that individuals searching for employment will experience a surge in interview invitations within this period.

If this desired outcome cannot materialize, ZipJob proactively offers a complimentary review and revision of your resume. This guarantee highlights their commitment to client contentment and showcases their unwavering belief in the superior quality of their resume writing services.

• The starting package is cost-effective
• Complimentary ATS check included
• 60-day interview assurance with higher-tier packages
• The design and layout made it challenging to read the resume
• The summary section was overly lengthy and filled with clichés
• The formatting of the education and training sections was subpar
• Expert resume writers: ZipJob provides access to a team of expert resume writers with the skills and knowledge to review, evaluate, and optimize your resume for compatibility with Applicant Tracking Systems (ATS) and hiring managers.
• ATS optimization: Meaning they ensure your resume is structured and formatted to navigate and succeed in ATS filters effectively. Employers commonly use these filters to assess and rank resumes during the initial screening process.
• Keyword optimization: The resume builder online offered by ZipJob assists you in identifying and integrating pertinent keywords and industry-specific terminology. This practice heightens the visibility of your resume, making it more likely to capture the attention of hiring managers.
• Job-specific content suggestions: ZipJob provides valuable advice regarding the most relevant and influential content to include in your resume for different job titles and industries. This guidance is invaluable in customizing your resume for specific roles.
• Cover letter writing assistance: ZipJob supports the creation of impactful cover letters that complement your resume, strengthening your overall job application.
• Unlimited revisions: One noteworthy feature of ZipJob is the option for unlimited revisions and updates to your resume. This ensures that your resume not only meets but continues to meet your specific requirements and mirrors your professional growth.
• Collaboration with resume writers: the platform facilitates direct collaboration with the resume writers, enabling you to share additional information, discuss specific requirements, and seek clarifications at any stage of the resume creation process.
• Launch Package: $139 (or $48/mo)
• Fast Track Package: $189 (or $65/mo)
• Premium Package: $299 (or $27/mo)

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Resumeble - Best Resume Builder With Custom Bundles

Star Rating: 4.3/5

Resumeble is a highly efficient and user-friendly resume builder that empowers individuals to create professional and compelling resumes. With Resumeble, crafting a standout resume becomes a streamlined process thanks to its intuitive interface and extensive range of customizable templates.

Whether you’re a recent graduate, a seasoned professional, or someone looking to change careers, Resumeble caters to all needs and skill sets. It offers helpful suggestions and expert advice to ensure your resume showcases your unique qualifications and achievements in the best possible light.

• A 60-day interview guarantee is included
• Budget-friendly package deals are available
• It’s more established than some other websites
• Keyword optimization: This feature helps optimize your resume by suggesting relevant keywords aligned with your target industry or job, enhancing your visibility to Applicant Tracking Systems (ATS) and recruiters.
• Content import: Resumeble allows you to import your existing resume or LinkedIn profile, saving you the time and effort of manual data entry.
• Real-time editing: You have the convenience of editing and modifying your resume in real time, providing the flexibility to experiment with various formats, sections, and content.
• ATS compatibility: Resumeble ensures your resume is ATS-compatible, essential for better visibility and a higher chance of being shortlisted by employers using Applicant Tracking Systems.
• Download options: The platform offers various download formats, including PDF, Word, and plain text, ensuring compatibility with diverse application processes.
• Cover letter builder: Resumeble features an integrated cover letter builder, streamlining the creation of professional and personalized cover letters that complement your resume.
• Career Pro Package : $159.00
• Professional Package : $299.00
• Premium Package : $399.00

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Let’s Eat, Grandma - Best Resume Builder for Range of Career Service

Star Rating: 4/5

Let’s Eat, Grandma is an inventive and progressive tool for creating impressive resumes. The platform streamlines the resume-building process, making it easier for job seekers to craft exceptional resumes. With Let’s Eat, Grandma, individuals can create unique resumes that catch the eye of employers and set them apart from the competition.

This user-friendly platform offers a range of customizable templates that allow users to tailor their resumes to showcase their specific skills and experiences. Let’s Eat, Grandma also provides expert advice and recommendations to help ensure that your qualifications and achievements are effectively highlighted in your resume.

• Complimentary resume evaluation
• Choices available for individuals from entry-level to executive-level positions
• Extensive collaboration opportunities
• Not specialized in academic CVs or federal resumes
• Relatively higher pricing compared to some other services
• Potential for a longer turnaround time compared to competing services
• Expert choice: You can save your resume in multiple formats (PDF, Word, plain text) or easily share it with potential employers via email or a link, simplifying the distribution of your resume.
• Error highlighting: The builder can identify potential errors, inconsistencies, or missing information within your resume and provide suggestions or alerts for improvement.
• Section prompts: Pre-written prompts for various resume sections (e.g., work experience, education, skills) can help you structure your resume effectively and ensure you include essential details in each area.
• Customizable sections: You can add, remove, or rearrange sections to tailor your resume to emphasize your strengths and relevant experiences.
• Keyword optimization: The resume builder can recommend industry-specific keywords based on the job description, enhancing your resume’s chances of passing through Applicant Tracking Systems (ATS) and grabbing the attention of hiring managers.
• Starter Package : Priced at $439, but there is an anti-inflation sale price of $389.
• Accelerated Package : $549.
• The premium Package : $689, but the anti-inflation sale price is $614.
• Executive Concierge Service : $1,899 or as low as $119/month.

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ResumeSpice - Best Resume Builder for Job Seekers of Any Level

Star Rating: 3.8/5

ResumeSpice , a renowned online resume builder, streamlines crafting professional resumes. This platform provides job seekers with a user-friendly interface and a wide selection of templates, enabling them to create impressive resumes that align with their career objectives.

With ResumeSpice’s seamless experience, users are guided through each resume section effortlessly while receiving valuable tips throughout the process. From personal details and work history to skills and accomplishments, this platform ensures that all crucial aspects of a resume are comprehensively addressed.

• Additional assistance
• Timely service
• ATS optimization
• Guaranteed interviews
• Restricted revisions
• Insufficient customization options
• Restricted refund policy
• User-friendly interface: ResumeSpice boasts an intuitive and user-friendly platform, simplifying the resume creation process and offering a seamless experience to users.
• Extensive template library: The platform offers a vast selection of professionally designed templates tailored to various industries and job positions. Users can explore different styles and layouts to find the perfect match for their needs.
• Import and export options: ResumeSpice enables users to import their existing resumes in formats like PDF or Word for easy editing and updates. Users can conveniently export their finalized resumes in multiple formats, facilitating sharing with employers or uploading to job portals.
• Mobile-friendly design: ResumeSpice is optimized for mobile devices, allowing users to create and modify their resumes using smartphones or tablets.
• Cloud storage: The platform provides secure cloud storage for users’ resumes, ensuring accessibility and updates from any device with an internet connection.
• Resume tracking: ResumeSpice includes tools for tracking the performance of submitted resumes, such as monitoring views, downloads, and application outcomes. These features empower users to evaluate their progress and make data-driven enhancements to their job search strategies.
• Entry Level Resume : $479
• Professional Resume : $589
• Executive Resume : $699

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TopResume - Best Resume Builder for Customer Service

Star Rating: 3.6/5

TopResume is an outstanding resume builder explicitly tailored for customer service professionals. It offers a seamless and user-friendly experience, enabling users to create exceptional resumes effortlessly. The platform goes beyond just providing a basic resume template, offering valuable suggestions and tips to optimize the content.

This ensures that each resume created on TopResume is unique and attention-grabbing in the highly competitive job market.

Besides its user-friendly interface, TopResume provides expert review services. These services allow skilled professionals to provide personalized feedback on resumes, helping enhance their overall quality further. By leveraging this feedback and incorporating attention to detail, customer service professionals can create compelling resumes that effectively capture the attention of potential employers.

• Streamlined registration process
• Well-designed and formatted one-page resume
• The summary and Job Scope sections were overly extended
• The training section needed to have prominence
• Skill-based sections: The resume builder features dedicated sections highlighting essential customer service skills, including communication, problem-solving, conflict resolution, and relationship building.
• Expert review services: TopResume provides expert review services where experienced professionals offer personalized feedback and recommendations to enhance the overall quality of your resume.
• ATS compatibility: The platform ensures that the resumes created are compatible with Applicant Tracking Systems (ATS), which employers commonly use for scanning and filtering resumes.
• Download and sharing options: Users can download their resumes in various formats, such as PDF or Word, and easily share them with potential employers or upload them to job portals.
• Industry-Specific Tips: TopResume offers industry-specific tips and guidance to assist users in tailoring their resumes to the customer service field, helping them stand out among competitors.
• Cover letter builder: Besides resume building, TopResume provides a builder that empowers users to craft professional and compelling cover letters customized for customer service roles.
• Mobile accessibility: The platform is mobile-friendly, allowing users to create, edit, and update their resumes while on the go, using their smartphones or tablets.
• Entry level : Up to 200$.
• Professional level : Up to 200$-400$.
• Executive level : Up to $350-$700.

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Resume Writing Services - Best Resume Builder for Affordability

Star Rating: 3.3/5

While Resumewritingservices.org may be a different size than its competitors, it stands out due to its team of talented and experienced resume writers. The website is user-friendly and provides exceptional service. However, this service’s true strength lies in its writers’ expertise.

Resumewritingservices.org sets itself apart by offering a comprehensive consultation process and goes beyond expectations by providing unlimited calls with its resume writers. This personalized approach distinguishes them from other companies and guarantees each client receives individual attention and support.

• Experienced resume writers of the highest caliber
• Unlimited phone consultations and revisions
• More expensive than rival services
• A limited range of products
• Skilled and experienced resume writers: Resumewritingservices.org takes pride in its team of highly trained and professional resume writers who possess a deep understanding of crafting effective resumes.
• Personalized service: Resumewritingservices.org offers a personal touch by providing unlimited calls with their resume writers. This unique feature allows clients to engage in direct communication and close collaboration with the writers throughout the resume creation process.
• Competitive job market expertise: The writers at Resumewritingservices.org have knowledge of current job market trends. This ensures that the resumes they create are optimized to excel in today’s fiercely competitive job market.
• Quality Assurance: The service maintains a rigorous quality assurance process to guarantee that the resumes delivered to clients meet the highest standards and align with their expectations.
• Timely delivery: Resumewritingservices.org is committed to delivering resumes within the agreed-upon timeframe, ensuring clients receive their documents promptly.
• Client satisfaction guarantee: Resumewritingservices.org offers a client satisfaction guarantee, assuring clients are fully content with the final resume. The service is ready to provide revisions if necessary.
• Affordable pricing: Resumewritingservices.org provides pricing options that are competitive and transparent, making professional resume writing accessible to a wide range of job seekers.

Resumewritingservices.org employs a pricing system that is clear and easy to understand for their resume-building services. The initial package begins at $270 , including a comprehensive consultation with a skilled resume writer and developing an individualized resume.

They offer extra options that enable customers to personalize their packages based on their unique preferences. This adaptable pricing strategy guarantees that clients can choose the services that align with their requirements and financial constraints.

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Craft Resumes - Best Resume Builder for Quick-Turnaround

Star Rating: 3/5

Craft Resumes stand out as a well-established writing and editing service known for its ability to deliver effective outcomes. Our dedication to providing a 24-hour turnaround guarantees you’ll receive the initial version of your resume promptly.

Navigating our user-friendly website is effortless, making it easy to use our services. At Craft Resumes, we specialize in crafting customized resumes to match your skills, qualifications, and aspirations for your career.

• Speedy completion
• Customized CVs
• Intuitive site
• Insufficient details
• Absence of assurances
• Quick turnaround: Craft Resumes commits to delivering the initial draft of your resume within 24 hours, ensuring a speedy and efficient service.
• Expert Writers: Craft Resumes prides itself on its team of experienced writers who possess expertise across various industries and stay up-to-date with current hiring trends. They’re dedicated to making your resume stand out and catch the attention of potential employers.
• Unlimited revisions: We provide unlimited revisions to guarantee your complete satisfaction. If you have specific changes or additions in mind, our team will collaborate with you closely to implement the modifications.
• Confidentiality and Privacy: At Craft Resumes, we prioritize the confidentiality and privacy of your personal information. You can trust that your data will be handled securely and with the utmost discretion.
• Tailored resumes: We specialize in tailoring resumes to align with your career objectives, industry, and job requirements. Each resume is personalized to accentuate your unique strengths and qualifications.
• Resume Writing : $229.00
• Basic : $279.99
• Optimal : $339.99
• All-In-One : $499.99

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Resume Companion - Best Value Resume Builder

Star Rating: 2.8/5

Resume Companion is a virtual platform and service that specializes in aiding individuals in creating resumes that are professional and impactful. It offers an array of resources and tools to assist job seekers in crafting interesting resumes that effectively showcase their skills, experiences, and qualifications.

A prominent feature of Resume Companion is its user-friendly resume builder. This tool allows users to select from various professionally designed templates and personalize them based on their specific requirements.

Users can effortlessly incorporate their personal information, employment history, educational background, skill set, and other pertinent details to produce a customized resume tailored to their needs.

• Intuitive user interface
• High-quality templates
• Efficiency-boosting functions
• Cost-effective choice
• Restricted editing features without subscription
• Absence of extensive customization options
• Limited availability of extra services
• Cover letter builder: Resume Companion goes beyond resumes and provides users with a tool for crafting customized cover letters tailored to specific job applications. This feature guides users through the process, helping them effectively present their qualifications and make a compelling case to prospective employers.
• ATS optimization: In today’s job market, many companies use Applicant Tracking Systems (ATS) to screen resumes. Resume Companion helps users ensure their resumes are ATS-friendly. The platform offers valuable tips and insights on incorporating relevant keywords, formatting the document correctly, and increasing the likelihood of passing through the ATS screening process.
• Educational resources: Resume Companion extends its services by offering an informative blog and educational materials that cover various aspects of resume writing, job search strategies, interview techniques, and career development guidance. These resources provide users with valuable insights and advice to help them create impressive resumes and enhance their job search efforts.
• Download and sharing options: Upon completing their resumes, users can conveniently download their documents in multiple formats, including PDF and Word. Resume Companion also makes it easy for users to share their resumes online or print them offline.
• Customer support: Resume Companion values user satisfaction and offers customer support to assist with users’ questions or concerns while utilizing the platform. Users can access support through email or the platform’s contact form.

Resume Companion provides a cost-effective solution for individuals seeking an all-inclusive service. It’s vital to remember subscription renewal is required to access future editing services. In summary, Resume Companion offers a wallet-friendly option for those who desire a user-friendly resume-building experience without needing advanced writing abilities.

>> Use Resume Companion to Secure Your Dream Job

Our Ranking Methodology for Best Resume Writing Services

To comprehensively and objectively rank the top resume writing services, it is essential to have a thorough methodology. The first step in this process was conducting extensive research and analysis. This involved gathering a comprehensive list of reputable resume-writing services from multiple sources such as online searches, customer reviews, industry directories, and personal recommendations.

• Feature analysis: Evaluate the functionalities provided by each resume builder, considering elements like template variety and quality, customization flexibility, user-friendly editing and formatting options, import/export capabilities, spell check and grammar tools, and integration with job search platforms and professional networks.
• Template collection: Examine the assortment and quality of templates. Look for a wide range that suits various industries, job levels, and design preferences, considering these templates’ aesthetics, readability, and contemporary design.
• Editing and customization: Scrutinize the adaptability and user-friendliness of the editing and customization tools each resume builder provides. Assess the capacity to add or modify sections, reorganize content, and tailor resumes to specific job requirements.
• User interface and experience: Analyze the user interface and the overall user experience each resume builder offers. Evaluate the ease of navigation, instruction clarity, guidance or prompts, and the platform’s responsiveness.
• Integration with job search platforms: Determine whether resume builders offer seamless integration with popular job search platforms and professional networks like LinkedIn or ATS systems. Consider how well the resumes can be transferred and their compatibility with these platforms.
• Additional resources: Evaluate if the resume builders provide extra resources such as sample resumes, tools for creating cover letters, interview tips, or career advice. Consider the breadth and practicality of these supplementary resources.
• Mobile-friendliness: Gauge the mobile-friendliness and responsiveness of the resume builders, recognizing the growing trend of mobile job searching and application processes.
• Customer support: Reflect on the accessibility and quality of customer support services, encompassing options like live chat, email support, or knowledge bases. Assess the responsiveness and helpfulness of the support team.
• Pricing and value for money: Appraise the pricing plans presented by the resume builders in terms of the value they offer based on features, usability, and overall service quality.
• Industry reputation: Consider the standing and trustworthiness of the resume builders, considering factors such as awards, recognition, partnerships, and user feedback from reputable sources.

Buyer’s Guide: Why Use a Resume Builder?

Crafting a well-crafted CV comes naturally to particular job seekers. However, even the most seasoned experts may need help in resume writing. If you find yourself in need of help with creating a compelling resume, here are several ways in which the best online resume builder can be beneficial:

Resume builders provide users with pre-designed templates and helpful tips, streamlining the process of writing a resume and alleviating stress.

Offers Writing Tips

Promoting oneself requires considerable effort. Only some people possess writing skills, even if they enjoy self-promotion. To showcase one’s experience and knowledge effectively, a resume builder can help select the most appropriate words and phrases.

Improves Design

In every field, there are unique standards for an impressive resume. If you need to gain knowledge in design or the tools, resume builders can provide free templates to enhance your resume’s visual appeal and quality.

Applicant Tracking Systems (ATS)

Recruiters often use ATS systems to scan resumes. A good resume builder will help with formatting to ensure that your resume is easy for these systems to read.

What’s the Best Resume Builder?

The ideal resume builder for each individual may differ according to their specific requirements. If you prefer a tool that offers step-by-step guidance in creating your resume, we suggest using a builder that provides helpful tips and recommendations. If you prefer a resume builder that auto-generates a summary, we recommend using a tool that extracts information from your LinkedIn profile.

For those who enjoy having creative control over their resumes, we suggest using a platform with features. By selecting the resume builder that aligns with your needs and suits your industry and personal style, you’ll significantly increase your chances of capturing the attention of hiring managers.

Resume Builder vs. Resume Writing Service: What Matters for You

When it comes to crafting a resume, there are three options available. You can opt to create it independently, use a resume builder tool, or enlist the services of a professional resume writer. Your best choice will depend on your writing abilities, available time, and financial resources.

Do-It-Yourself

You have the choice to construct a resume entirely by yourself. The benefit of this option is that it costs nothing but requires a significant amount of effort. Along with composing all the information, you must possess graphic design skills.

This approach works well if you have these abilities, but with them, your options for creating a resume are unlimited. To overcome this limitation, you can use a resume builder or enlist the help of a resume writing service.

Resume Builder

A tool for creating resumes allows you to input your details into a template, resulting in an original appearance and layout with no design work. The top resume building tools also offer suggestions on enhancing your resume and tailoring it to match the specific job you are applying for.

While you are still responsible for writing the content, once it is written, you can quickly transfer that information into any other template with just a few simple clicks. Some of these services are free and many like to promote themselves as such, but most require a small payment to download your finished resume.

Professional Resume Writing Service

Professional resume writing services are expensive, but they offer the convenience of handling all the work for you. An experienced writer will gather relevant information about your background and transform it into a unique and engaging resume.

The process typically takes a few days, and the level of originality in the outcome largely relies on your choice of company and writer. However, we will not delve into these services further in this guide.

Are Resume Builders Worth It?

Definitely, without a doubt. An effective resume creator will guarantee that your CV is formatted correctly to navigate Applicant Tracking Systems and ultimately reach the hands of recruiters.

Is It Unprofessional to Use a Microsoft Word Resume Template?

Relying on a template will not set you apart, and there is a high likelihood that your application will be dismissed because your resume is identical to those of other job seekers.

Final Thoughts

Choosing the right resume builder is crucial in today’s competitive job market. Creating a professional and impactful resume that stands out from the crowd can significantly impact your job search. With the right tool, you can save time, improve your chances of landing an interview, and ultimately secure your dream job.

When selecting a resume builder, consider your specific needs and priorities. Look for features like customizable templates, industry-specific examples, and the ability to export your resume in different formats. Consider user reviews and ratings to ensure you choose a reputable and reliable platform.

Remember, an exceptional tool for crafting resumes should give you the power to present your skills, experience, and accomplishments effectively. It should simplify and expedite creating a resume without hassle. Investing in a reliable resume builder is investing in your professional future.

Therefore, explore the different options available for resume builders. Test out their free trials or demos and choose the best fit for your objectives. Our top recommendation is Super Star Resume . This meticulously designed resume can open doors to exciting career prospects and be a dependable companion on your journey toward success.

Ahad Waseem is a business, blockchain, and cybersecurity writer who often takes on art, politics, and economics too. As a linguistic engineer who writes to solve problems, he’s written for various tech and business publications. When he’s not writing, he’s probably on horseback, caring for his houseplants, or training Bonsai trees. He can be reached at [email protected] . McClatchy’s newsrooms were not involved in the creation of this content. We may earn a commission if you make a purchase through one of our links.

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Zelenskiy calls for operational changes to Ukraine military after sacking commander

President demands ‘new level of medical support for soldiers’ as questions mount over speed of counteroffensive against Russia

Volodymyr Zelenskiy has demanded rapid changes in the operations of Ukraine’s military and announced the dismissal of the commander of its medical forces.

The Ukrainian president’s move was announced on Sunday as he met defence minister, Rustem Umerov, and coincided with debate over the conduct of the 20-month-old war against Russia , with questions over how quickly a counteroffensive in the east and south is proceeding.

“In today’s meeting with defence minister Umerov, priorities were set,” Zelenskiy said in his nightly video address. “There is little time left to wait for results. Quick action is needed for forthcoming changes.”

Zelenskiy said he had replaced Maj Gen Tetiana Ostashchenko as commander of the medical forces.

“The task is clear, as has been repeatedly stressed in society, particularly among combat medics, we need a fundamentally new level of medical support for our soldiers,” he said.

This, he said, included a range of issues – better tourniquets, digitalisation and better communication.

Umerov acknowledged the change on the Telegram messaging app and set as top priorities digitalisation, “tactical medicine” and rotation of service personnel.

Ukraine’s military reports on what it describes as advances in recapturing occupied areas in the east and south and last week acknowledged that troops had taken control of areas on the eastern bank of the Dnipro River in southern Kherson region.

Ukrainian commander in chief, Gen Valery Zaluzhny, in an essay published this month, said the war was entering a new stage of attrition and Ukraine needed more sophisticated technology to counter the Russian military.

While repeatedly saying advances will take time, Zelenskiy has denied the war is headed into a stalemate and has called on Kyiv’s western partners, mainly the United States, to maintain levels of military support.

Ostashchenko was replaced by Maj Gen Anatoliy Kazmirchuk, head of a military clinic in Kyiv.

Her dismissal came a week after a Ukrainian news outlet suggested her removal, as well as that of others, was imminent after consultations with paramedics and other officials responsible for providing support to the military.

Meanwhile on Sunday, air defence units in Moscow intercepted a drone targeting the city, mayor Sergei Sobyanin said.

Sobyanin, writing on the Telegram messaging app, said units in the Elektrostal district in the capital’s east had intercepted the drone.

According to preliminary information, falling debris resulting from the operation had caused no casualties or damage, Sobyanin said.

• Volodymyr Zelenskiy

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