Regulatory Medical Writing Lead - Stoke-on-Trent
Client: Cpl Life Sciences
Location: Stoke-on-Trent, United Kingdom
Job Category: Other
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 office
Remuneration: £75,000 - £99,000 plus car allowance and bonus
This is an opportunity to join a growing specialty pharmaceutical company focusing on developing innovative treatments for challenging diseases, including immuno-oncology, gene therapy, and others.
The role involves acting as a Global Medical Writing Lead within mid- to late-stage global project teams, providing leadership on program documents, and acting as an expert on IND/IMPD dossiers, briefing documents, and regulatory responses.
The individual will analyze program and study documents for clarity, accuracy, and regulatory compliance, ensuring high-quality outputs that align with corporate strategies and global regulations.
Responsibilities
* Lead assigned programs, primarily in mid- to late-stage development
* Provide intellectual leadership and document expertise to global project teams
* Serve as departmental expert on IND/IMPD dossiers and regulatory responses
* Review documents for consistency with strategies and standards
* Adjust document content to meet specific project needs within templates
* Participate in departmental initiatives and process improvements (up to 15% of time)
* Support management in departmental performance and outsourcing evaluations
Required Qualifications
* BA/BS degree or equivalent with 10+ years of relevant experience; PhD/PharmD or MS/MA/MPH preferred
* Extensive experience in medical writing, especially in IND/IMPD and NDA/MAA components
* Strong leadership, communication, and strategic thinking skills
Note: This is a senior role requiring extensive RA medical writing experience. You must have the right to work in the UK; sponsorship is not provided.
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