Director of Medical Writing

Job Summary

Providing strategic and operational medical writing expertise, the full-time Director of Medical Writing will independently author and lead the development of complex clinical and regulatory documents for health authority submissions, collaborating with cross-functional teams in a hybrid work environment.

Key Responsibilities

• Develop and execute strategies for organizing and preparing clinical and regulatory documents for submissions
• Independently author and lead the development of protocols, Investigator Brochures, CSRs, and other essential documents for oncology drug development
• Manage contract medical writers and ensure the quality and consistency of documents across programs

Required Qualifications

• Advanced degree in life sciences; PhD preferred
• At least 8+ years of sponsor-level biotechnology or pharmaceutical clinical/regulatory medical writing experience
• Extensive experience in oncology-focused medical writing and regulatory submissions
• Recent direct experience with NDA submissions and authoring eCTD Module 2 clinical summaries
• Strong project management and leadership skills with the ability to manage competing priorities