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.

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

Senior Medical Writer

Key skills