Medical Writer
Posted Today by Apsida Life Science
Negotiable
Undetermined
Remote
United Kingdom
Summary: The role of an Experienced Medical Writer focuses on regulatory dossier authoring, specifically leading the creation and finalization of Common Technical Document (CTD) modules for regulatory submissions. The position requires collaboration with various teams to ensure compliance with regulatory standards and the development of Risk Management Plans. This fully remote contract position is aimed at individuals with significant experience in medical writing within the life sciences sector.
Key Responsibilities:
- Lead the planning, authoring, editing, and finalization of CTD modules 2, 4, and 5 for regulatory submissions.
- Ensure all regulatory documents adhere to current regulatory guidance and company standards.
- Collaborate cross-functionally with Clinical Development, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams.
- Author and finalize briefing books for scientific advice meetings to support development programs.
- Develop, author, and maintain Risk Management Plans in alignment with regulatory requirements.
- Manage the document lifecycle, including version control, comment resolution, and final sign-off.
Key Skills:
- Advanced degree (PhD, Pharm.D., M.D., or Master's) in a relevant life sciences discipline.
- Minimum of 5+ years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
- Extensive experience in writing briefing books for scientific advice meetings.
- Expertise in authoring Risk Management Plans.
- Direct experience with authoring and compiling regulatory documents for CTD Modules 2, 4, and 5.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job Title: Experienced Medical Writer (Regulatory Focus)
Location : United Kingdom Residents Only - Fully remote
Contract Period: 6 Months (Contract)
Company Overview: Apsida Life Science has partnered with strategic firm that is a specialised cross-functional consulting firm supporting companies in the life science and healthcare sectors. They provide strategic and operational expertise across the product lifecycle, focusing on regulatory affairs, quality assurance, market access, and commercial strategy.
The Opportunity: Regulatory Dossier Authoring. Lead the planning, authoring, editing, and finalization of Common Technical Document (CTD) modules 2, 4, and 5 (Quality, Nonclinical, and Clinical Summaries and Reports) for regulatory submissions (e.g., NDA/BLA, MAA). Ensure all regulatory documents adhere to current regulatory guidance (e.g., ICH, FDA, EMA) and company standards. Collaborate cross-functionally with Clinical Development, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams to source, interpret, and integrate data into documents. Author and finalize briefing books and related documentation for scientific advice meetings (e.g., FDA, EMA, national health authorities) to support development programs and address regulatory questions. Develop, author, and maintain Risk Management Plans (RMPs) in alignment with regulatory requirements and the company’s pharmacovigilance strategy.
General Medical Writing. Manage the document lifecycle, including version control, comment resolution, and final sign-off.
Qualifications: Advanced degree (PhD, Pharm.D., M.D., or Master's) in a relevant life sciences discipline. Minimum of [5+] years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry. Extensive, proven experience in writing briefing books for scientific advice meetings. Expertise in authoring Risk Management Plans (RMPs). Direct experience with authoring and compiling regulatory documents for CTD Modules 2, 4, and 5.
What You Will Get: Competitive salary Impactful work Work-life balance
If you are interested in learning more, please reach out to Linda Goba at Apsida Life Science: Linda.goba@apsida.com +44 (0) 744 134 2145 Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best