Job Title: Experienced Medical Writer (Regulatory Focus)
Location: United Kingdom - 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
www.apsida.co.uk
+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