Senior Medical Writer
Ipsen
full-time
Posted on:
Location Type: Office
Location: London • United Kingdom
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Job Level
Tech Stack
About the role
- Overseeing the planning, development, and delivery of high-quality clinical and regulatory documents across multiple assets and therapeutic areas.
- Ensuring alignment with global regulatory standards and driving innovation in medical writing practices.
- Providing leadership across cross-functional teams and contributing to regulatory strategy.
- Managing the delivery of all writing activities for assigned assets (from FIH through Phase 3 and Regulatory submissions).
- Actively contributing to best practices and continuous improvement across asset teams.
- Championing process optimization, automation, and digital tools.
Requirements
- Bachelor’s degree in Life Sciences (advanced degree preferred)
- Minimum of 7 years Medical Writing experience in either a CRO or pharmaceutical company
- Demonstrated budget- and people-management success
- Proven leadership experience managing teams and vendors in a matrixed, global environment
- Demonstrated success in leading regulatory writing for major submissions (e.g., NDA/BLA/MAA)
- Strong understanding of ICH guidelines, GCP, and global regulatory requirements
- Excellent level of English both written and verbal
Benefits
- Health insurance
- Paid time off
- Flexible working hours
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingregulatory writingbudget managementpeople managementprocess optimizationautomationdigital toolsregulatory submissionsclinical documentationtherapeutic areas
Soft Skills
leadershipcross-functional collaborationcommunicationteam managementstrategic thinkinginnovationcontinuous improvementproblem-solvingadaptabilityinterpersonal skills
Certifications
Bachelor’s degree in Life Sciencesadvanced degree in Life Sciences