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Apsida Life Science

Medical Writer

Full-Time No home office possible

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Direct message the job poster from Apsida Life Science

Collaborating with Top Talent and Innovative Organisations to Shape the Future of Life Sciences.

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 a 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:

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: