Principal Medical Writer
ICON · Frankfurt, Germany +8 more
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Role summary
A global clinical research organization seeks a Principal Medical Writer to lead development of regulatory and clinical documents for global biotech submissions. The permanent, single-client dedicated role requires 6+ years of biopharmaceutical writing experience, expertise in clinical study reports and regulatory compliance, and strong project management skills. Positions available across multiple European locations.
What they're looking for
- Bachelor's degree in life science discipline; Master's preferred
- Minimum 6 years medical writing experience in biopharmaceutical or CRO settings
- Expertise writing Clinical Study Reports, Investigator's Brochures, and Protocols
- Demonstrated leadership in regulatory submissions and document development
- Proficiency with domestic and international regulatory requirements and ICH guidelines
- Strong project management, organizational, and communication abilities
- Oncology experience considered advantageous
What you'll be doing
- Author regulatory documents for global agency submissions including Clinical Study Reports and Clinical Summaries
- Lead medical writing projects with timeline development and cross-functional team coordination
- Participate in cross-functional meetings to address deliverables, timelines, and document completion processes
- Review associated project documents such as protocols and statistical analysis plans
Privacy & handoff
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