Regulatory Medical Writing Lead - Stockport
Client: Cpl Life Sciences
Location: Stockport, United Kingdom
Job Category: Other
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EU work permit required: Yes
Job Views: 1
Posted: 22.08.2025
Expiry Date: 06.10.2025
Job Description:
Job Role: Regulatory Medical Writing Lead
Job Type: Full-time, permanent
Job Location: UK, Remote – Travel once a quarter to Surrey
Remuneration: £75,000 - £99,000 plus car allowance and bonus
Join a growing specialty pharmaceutical company focused on developing innovative treatments for challenging diseases, including immuno-oncology, gene therapy, and more.
Act as a Global Medical Writing Lead in mid- to late-stage development projects, providing leadership on program documents and acting as departmental expert on IND/IMPD dossiers, briefing documents, and regulatory responses.
Analyze proposed documents for accuracy, consistency, and regulatory compliance, ensuring high-quality outputs aligned with corporate strategy.
Responsibilities:
* Lead assigned programs, especially in mid- to late-stage development.
* Provide intellectual leadership and document expertise to global project teams.
* Serve as departmental expert on regulatory dossiers and responses.
* Review documents for consistency, quality, and strategic alignment.
* Adjust document content within provided templates to meet specific needs.
* Participate in departmental initiatives and process improvements (up to 15% of time).
* Support performance improvement and outsourcing evaluations.
Required Qualifications:
* BA/BS degree or equivalent, with 10+ years of relevant experience. Preferred: PhD/PharmD or MS/MA/MPH with at least 10 years in pharmaceutical medical writing, including 2-5 years managing regulated document creation.
* Technical expertise in all medical writing document types.
* Extensive experience in IND/IMPD and NDA/MAA components, regulatory responses, and advisory committee preparation.
* Strong leadership, communication, and strategic thinking skills.
Note: This is a senior role requiring extensive RA medical writing experience. You must have full right to work in the UK; sponsorship is not provided.
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