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Senior Manager, Regulatory Medical Writing, Basildon
Client:
Cpl Life Sciences
Location:
Basildon, 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: Senior Manager, Regulatory Medical Writing
Job Type: Full-time, permanent
Job Location: UK, Remote – Travel 1x a quarter to the office in Surrey
Remuneration: £56,000 - £75,000 plus car allowance and bonus
An opportunity to join a growing specialty pharmaceutical company focusing on developing innovative treatments for hard-to-treat diseases, including immuno-oncology, gene therapy, mitochondrial biology, blindness, regeneration, and targeted protein degradation.
Acts as a Global Medical Writing Lead in mid- to late-stage development global project teams, providing leadership on program documents and acting as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities.
The individual independently analyzes proposed program, study, and related documents for accuracy, consistency, and ability to deliver the required information to target audiences, ensuring high-quality document production that meets corporate and global regulatory standards.
Responsibilities:
* Lead all assigned programs (generally mid- to late-stage development).
* Provide intellectual leadership and contribute document knowledge to the global project team.
* Act as departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulators.
* Review documents for consistency with strategy and history, ensuring high-quality output.
* Adjust document content within templates to meet specific needs.
* Participate in departmental initiatives and process improvements (up to 15% of time).
* Support departmental performance improvements and outsourcing evaluations.
Required Qualifications:
* BA/BS degree or equivalent, 10+ years relevant experience. Preferred: PhD/Pharm D 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 leading IND/IMPD and NDA/MAA components, briefing documents, and regulatory responses, with preferred experience in advisory committees.
* Strong communication, leadership skills, and strategic thinking.
Note: This is a senior role requiring extensive RA medical writing experience and excellent communication skills. The role does not offer sponsorship; candidates must have full right to work in the UK and reside in the UK.
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