Medical Writer I role focusing on document management within Veeva systems for clinical projects. Supporting compliance and adherence to GxP guidelines while collaborating with stakeholders.
About the role
- Senior Medical Writer overseeing high-quality clinical and regulatory documents at Ipsen, a biopharmaceutical company. Leading cross-functional teams and contributing to regulatory strategy while ensuring compliance and innovation in medical writing practices.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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