Director of Medical Writing

Job Summary

A company is looking for a Director, Medical Writing.

Key Responsibilities

• Lead Medical Writing efforts and strategy for drug development programs, ensuring high-quality deliverables
• Oversee and manage medical writers, providing leadership and mentorship
• Collaborate with various departments to drive clinical filing dossiers and improve writing processes

Required Qualifications

• Bachelor's degree in Life Science or English/Communications; advanced degree preferred
• 10+ years of medical writing experience, preferably in a sponsor setting
• Experience in leading clinical dossier preparation for global regulatory filings
• 3+ years of management experience in medical writing
• In-depth knowledge of Good Clinical Practices and FDA regulations