Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer to lead and manage complex clinical regulatory documents.

Key Responsibilities

• Lead the Medical Writing department on multiple project/core teams
• Write and manage complex clinical regulatory documents and support the Global Regulatory Lead
• Coordinate with Regulatory Operations to ensure timely preparation of regulatory submission documents

Required Qualifications

• Bachelor's degree and a minimum of 8 years of experience as a medical writer in the pharma or biotech industry
• Experience as lead writer for key documents in major US and/or international regulatory submissions
• In-depth experience writing Safety sections of regulatory documents is strongly preferred
• Extensive knowledge of FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6
• Ability to independently write and complete documents