Principal Medical Writer

Job Summary

To support clinical projects in Cardio/Metabolic Health, the full-time Principal Medical Writer will manage and author clinical and regulatory documents, coordinate with cross-functional teams, and ensure adherence to regulatory standards while working remotely.

Key responsibilities

• Independently authors and manages clinical program documents, including protocols and regulatory submissions
• Leads cross-functional coordination of resources to ensure timely delivery of medical writing and quality control deliverables
• Supervises and mentors less experienced medical writers while maintaining communication with clients and stakeholders

Required qualifications

• Bachelor's degree or higher in a medical or scientific discipline
• Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, or medical devices
• Advanced knowledge of FDA regulations and regulatory submission processes
• Proficiency in MS Word and experience with document formatting, including tables and figures
• Strong project management skills and ability to work independently with minimal supervision