About this role
Role Overview
- Lead authoring and development of high complexity clinical regulatory documents
- Spearhead the entire process from initial planning and coordination through all stages of development
- Maintain alignment with sponsor goals, project status and milestones across all teams
- Critically interpret raw study data into clear concise language in Protocols and CSRs
Requirements
- Advanced degree in life-sciences (PhD or Masters)
- Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project lead
- Extensive experience and proficiency in writing and leading development of CSRs and Protocols
Benefits
- Comprehensive training
- Management support
- Opportunities to help you thrive