Sr Manager, Medical Writing

📋 Description

• Author, edit, finalize complex regulatory/clinical docs
• Lead FDA briefing docs and RMAT/Breakthrough related materials
• Develop clinical protocol synopses and study protocols
• Collaborate with Clinical Development, Regulatory, Biostatistics, and others
• Translate data into regulatory narratives
• Own timelines and ensure timely, high-quality delivery

🎯 Requirements

• Advanced degree in Life Sciences or related field preferred
• 10+ years medical writing in biotech/pharma
• Experience authoring FDA regulatory docs and briefing packages
• Experience with RMAT/Breakthrough interactions
• Strong protocol development and ICH/GCP knowledge
• Experience in autoimmune diseases valued

🎁 Benefits

• National salary range of $170,000–$190,000 USD annually
• Bonus eligibility
• Stock plan participation
• Comprehensive benefits
• Fully remote work environment in the United States
• Collaborative cross-functional environment