Principal Medical Writer - CMC

Job Summary

Leading the authorship of regulatory documents, the full-time Principal Medical Writer - CMC will manage client engagements, mentor team members, and ensure high-quality documentation for regulatory submissions in a fully remote environment.

Key responsibilities

• Author and lead the development of regulatory documents, including Modules 3 and 2.3
• Mentor junior writers and provide subject matter expertise in Chemistry, Manufacturing, and Controls documentation
• Ensure compliance with regulatory authority guidelines and manage project teams effectively

Required qualifications

• Bachelor's degree or higher in a scientific discipline
• 7+ years of regulatory writing experience, specifically with CMC documentation
• Experience with regulatory submissions such as NDAs, INDs, and BLAs
• Proven track record in authoring Modules 3 and 2.3
• Strong understanding of global health authority requirements and the drug development lifecycle