Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer.

Key Responsibilities

• Lead and manage the writing of complex clinical regulatory documents
• Support regulatory submissions and interact with regulatory agencies
• Coordinate with cross-functional teams to ensure clarity and consistency in messaging

Required Qualifications

• Bachelor's degree with a minimum of 8 years of experience in medical writing
• Experience as a lead writer for major US and/or international regulatory submissions
• In-depth experience writing safety sections of regulatory documents preferred
• Extensive knowledge of FDA, EMA, and ICH guidelines
• Ability to independently complete documents to completion