Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer to lead medical writing activities for regulatory submissions.

Key Responsibilities

• Lead the writing strategy and manage medical writing activities within designated therapeutic areas
• Coordinate document preparation for regulatory submissions, ensuring adherence to requirements
• Serve as lead writer for key regulatory response documents and represent medical writing on cross-functional teams

Required Qualifications

• Bachelor's degree in science, health profession, or journalism
• At least 5 years of experience writing for pharmaceutical or biotechnology industries
• 3+ years of experience with electronic documents and submissions
• Experience as lead writer for major regulatory submissions
• Project or people management experience preferred