Principal Medical Writer

Job Summary

A company is looking for a FSP Principal Medical Writer.

Key Responsibilities

• Serve as the medical writing oversight director and lead writer on large projects, ensuring compliance with quality processes
• Write complex documents and provide senior review, including study reports, protocols, and regulatory submissions
• Oversee and mentor medical writers and program managers, developing best practices and leading process improvement initiatives

Required Qualifications

• Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred
• 12+ years of relevant experience in managing complex medical writing projects
• Experience in the pharmaceutical/CRO industry is preferred
• Submissions document experience is advantageous
• Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous