Medical Writer CV Example
A medical writer CV should highlight your ability to produce clear, accurate scientific and regulatory documents for pharmaceutical and healthcare audiences.
Recommended template: MinimalPro
Key Skills to Include
Quick Tips
- Include a portfolio or list of published documents and articles.
- Highlight familiarity with regulatory guidelines such as ICH-E3 and CTD format.
- Detail your therapeutic area expertise and relevant scientific background.
- Showcase your ability to translate complex science into accessible language.
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Upgrade to ProHow to Write Your Medical Writer CV
A medical writer CV must demonstrate your ability to produce accurate, well-structured documents that meet regulatory, publication, or communication objectives. Employers want evidence that you can manage complex writing projects, collaborate with scientific and clinical experts, and deliver high-quality documents under pressure. Your CV should highlight your therapeutic area expertise, familiarity with relevant guidelines, and portfolio of completed documents.
CV Structure
Use a reverse-chronological format with sections for your profile, experience, education, publications, and skills. Each role should describe the employer, client types, and document types you produced. Follow with achievements that demonstrate quality, speed, or client satisfaction. Include a publications or portfolio section if you have authored peer-reviewed papers or can list key regulatory documents without breaching confidentiality.
CV Format
Select a clean, professional template. Medical writing is a detail-oriented profession, so your CV formatting should reflect precision and consistency. Use a legible font, consistent heading styles, and well-structured bullet points. Include your professional society memberships (EMWA, AMWA, ISMPP) prominently. Save as a PDF.
CV Profile Examples
Senior Medical Writer
Senior medical writer with eight years of experience producing regulatory and publication documents for the pharmaceutical industry. Expert in clinical study reports, investigator brochures, and CTD Module 2 summaries with therapeutic area depth in oncology and immunology. Skilled in managing multiple writing projects simultaneously and collaborating with cross-functional teams to deliver high-quality documents to regulatory timelines.
Regulatory Medical Writer
Regulatory medical writer specialising in Module 2.5 and 2.7 clinical summary documents for marketing authorisation applications. Experienced in writing for both EMA and FDA submissions, with strong knowledge of ICH-E3, ICH-M4, and eCTD formatting requirements. Known for producing clear, accurate documents that withstand regulatory scrutiny and facilitate efficient review cycles.
Junior Medical Writer
PhD-qualified medical writer with two years of experience in a medical communications agency, producing peer-reviewed manuscripts, congress posters, and slide decks for pharmaceutical clients. Strong scientific background in respiratory medicine with excellent writing, editing, and referencing skills. AMWA and EMWA member committed to ethical publication practices and compliance with GPP3 guidelines.
Summarise your years of medical writing experience, therapeutic area expertise, document types you specialise in, and any headline achievements. State whether you focus on regulatory writing, publications, or medical communications to help recruiters assess your fit.
Key Skills for Your Medical Writer CV
Regulatory Writing
Producing clinical study reports, protocols, investigator brochures, and CTD summary documents for regulatory submissions to EMA and FDA.
Clinical Study Reports
Authoring comprehensive CSRs in ICH-E3 format that accurately present clinical trial design, results, and safety data.
Scientific Publications
Drafting peer-reviewed manuscripts, review articles, and congress abstracts for publication in medical and scientific journals.
ICH Guidelines
Applying ICH-E3, ICH-E6, ICH-M4, and other guidelines to ensure regulatory documents meet international pharmaceutical standards.
Medical Terminology
Using precise medical and scientific terminology to communicate clinical findings accurately to specialist audiences.
Literature Reviews
Conducting systematic and narrative literature searches to summarise clinical evidence and support regulatory and publication projects.
Editing & Proofreading
Reviewing documents for accuracy, consistency, and compliance with style guides, regulatory requirements, and publication standards.
Reference Management
Using EndNote, Citavi, or Zotero to manage citations and reference libraries across multiple concurrent writing projects.
Plain-Language Writing
Translating complex clinical and scientific information into clear, accessible summaries for patients, carers, and non-specialist audiences.
Work Experience Examples
Describe the types of documents you produce, the therapeutic areas you cover, and the regulatory or publication frameworks you work within. Quantify your output — number of CSRs authored, manuscripts published, or projects managed simultaneously. Include examples of quality outcomes such as successful regulatory submissions or publications in high-impact journals.
Senior Medical Writer
Parexel, Uxbridge
Led the preparation of regulatory and clinical documents for Phase II to Phase IV pharmaceutical development programmes across oncology, rare disease, and cardiovascular therapeutic areas.
Responsibilities
- Authored clinical study reports, protocols, and investigator brochures in accordance with ICH-E3 and ICH-E6 guidelines.
- Prepared CTD Module 2.5 Clinical Overview and Module 2.7 Clinical Summary documents for marketing authorisation applications to EMA and FDA.
- Managed document timelines, coordinating internal reviews, author meetings, and quality control checks to ensure on-time delivery.
- Collaborated with biostatisticians, clinical teams, and regulatory affairs to ensure accurate interpretation and presentation of clinical data.
- Mentored junior writers, reviewing their drafts and providing constructive feedback on structure, language, and regulatory compliance.
Achievements
- Delivered the clinical study report for a pivotal Phase III oncology trial three weeks ahead of the regulatory submission deadline, contributing to a successful MAA.
- Developed a clinical study report template and style guide that reduced average first-draft review comments by 25% across the writing team.
- Received client commendation for producing a CTD Module 2.5 Clinical Overview that the FDA reviewer described as exceptionally clear and well-organised.
Medical Writer
Oxford PharmaGenesis, Oxford
Produced peer-reviewed manuscripts, systematic literature reviews, and congress materials for pharmaceutical clients in the immunology and gastroenterology therapeutic areas.
Responsibilities
- Drafted manuscripts for submission to high-impact journals, managing the submission, peer review, and revision process on behalf of author teams.
- Conducted systematic literature searches and produced narrative and systematic reviews to support clinical development and health technology assessment submissions.
- Created congress posters, oral presentation slide decks, and plain-language summaries for patient and public audiences.
- Ensured all publications complied with GPP3, ICMJE authorship criteria, and journal-specific requirements.
Achievements
- Published seven peer-reviewed manuscripts in a single year across journals including The Lancet Gastroenterology & Hepatology and Alimentary Pharmacology & Therapeutics.
- Received the company's annual quality award for consistently delivering publication projects with zero major revisions from client medical directors.
Education & Qualifications
List your PhD or advanced degree first, specifying the scientific discipline. Include any medical writing qualifications such as AMWA certificates, EMWA professional development programme, or university postgraduate certificates. Mention relevant scientific or medical degrees.
PhD in a Biomedical Science
Doctoral qualification providing the scientific expertise needed to understand and write about clinical research accurately.
AMWA / EMWA Membership
Membership of the American or European Medical Writers Association demonstrating professional commitment to medical writing standards.
Regulatory Writing Certificate
Formal qualification in regulatory medical writing covering CSR structure, CTD format, and ICH guidelines.
ISMPP Certification (CMPP)
Certified Medical Publication Professional credential demonstrating expertise in ethical publication practices.
Frequently Asked Questions
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