Principal Medical Writing Domain Expert - Falcon

📋 Description

• Lead vision for an AI-enabled regulatory authoring platform
• Define document generation frameworks from data to regulatory submissions
• Establish objective quality criteria, review protocols, and verification
• Direct content instructions to capture cyclical updates and complex narratives
• Support commercial cycles with medical writing expertise
• Partner with early adopters on change management and adoption

🎯 Requirements

• 7+ years medical writing in pharma/biotech/CROs
• Deep understanding of global regulations (ICH E3) and data mapping
• Excellent communication, presentation, and relationship management
• Passion for AI and forward-thinking regulatory workflows

🎁 Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company holidays
• Retirement programs
• 1% charitable giving program