Principal Medical Writer

Job Summary

Leading the development of clinical and regulatory documents, the contract Principal Medical Writer will manage projects from initial planning through final submission in a remote setting.

Key responsibilities

• Write and manage complex clinical and regulatory documents, including protocols and clinical study reports
• Lead document planning, timelines, cross-functional reviews, quality control, and final delivery
• Partner with various functional teams including Clinical, Regulatory, and Safety to ensure comprehensive document development

Required qualifications

• 6 or more years of pharmaceutical or biotechnology regulatory or medical writing experience
• 4 or more years of regulatory document project management experience
• Strong clinical and regulatory document writing experience; nonclinical and CMC writing experience is preferred
• Proven project management and organizational skills with the ability to manage multiple documents and timelines independently
• Bachelor's degree required; advanced degree preferred