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Medical Writer
Résumé du poste
A leading life sciences consulting firm is looking for an Experienced Medical Writer to join their team. This fully remote role requires an advanced degree and at least 5 years of medical writing experience, particularly in regulatory documents and briefing books. You will lead the planning and finalization of CTD modules while collaborating across various teams. The position offers a balance between work and personal life and presents an opportunity to contribute significantly to regulatory submissions.
Prestations
Qualifications
- 5+ years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
- Proven experience in writing briefing books for scientific advice meetings.
- Direct experience with authoring and compiling regulatory documents for CTD Modules 2, 4, and 5.
Responsabilités
- Lead the planning, authoring, editing, and finalization of CTD modules.
- Ensure regulatory documents adhere to current guidance and standards.
- Collaborate with multidisciplinary teams to source and integrate data.
Connaissances
Formation
Direct message the job poster from Apsida Life Science
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.
- 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 programmes 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.
- 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.
- 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
- Mid‑Senior level
- Contract
- Writing/Editing
- Pharmaceutical Manufacturing
* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.