Director, Principal Medical Writer, Europe
Revolution Medicines · Basel, Switzerland
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Revolution Medicines seeks an experienced Principal Regulatory Medical Writer in Basel to author and coordinate high-quality regulatory documentation for European clinical development and marketing authorization activities. The role involves leading complex submissions to Health Authorities while collaborating across clinical, regulatory, and biometrics teams throughout the product lifecycle.
What they're looking for
- Extensive experience authoring clinical regulatory documents for European submissions
- Deep knowledge of ICH guidelines, EMA guidance, GCP, and EU regulatory requirements
- Demonstrated expertise in Risk Management Plans, Health Authority responses, and scientific advice packages
- Proven ability to manage cross-functional teams and lead document review cycles
- Strong understanding of oncology drug development and RAS-targeted therapies
- Excellent scientific writing and communication skills with attention to detail
What you'll be doing
- Author and finalize clinical regulatory documents including EMA responses, RMPs, and safety reports
- Serve as lead writer for complex regulatory submissions supporting Health Authority interactions
- Coordinate multidisciplinary input and manage document review cycles to meet timelines
- Ensure regulatory compliance with ICH, EMA, and company standards across all documents
- Mentor junior medical writers and contribute to process improvements and best practices
Privacy & handoff
This role links to Revolution Medicines's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.