Director of Medical Writing

Job Summary

A company is looking for a Director, Medical Writing.

Key Responsibilities:

• Write or supervise the writing of complex clinical and regulatory documents to support clinical development programs
• Ensure high-quality content and provide recommendations for enhancements while managing cross-functional feedback
• Mentor medical writers and develop medical writing processes and standards

Required Qualifications:

• More than 7 years of Medical Writing experience with increasing responsibility
• Experience writing Clinical Overviews and Integrated Summaries for BLA/NDA submissions
• Knowledge of oncology-related regulations in medical writing
• B.S. or equivalent degree in a scientific area; advanced degree preferred
• Experience managing medical writers is preferred