Analytical CMC Technical Writer

Job Summary

To support external drug substance and drug product development programs, the remote Analytical CMC Technical Writer will provide scientific leadership, manage documentation workflows, and collaborate with internal and external teams on regulatory submissions.

Key Responsibilities:

• Provide scientific leadership in external analytical development and quality control for drug substances and products
• Contribute to stability programs and review quality agreements, study protocols, and batch data
• Manage documentation in the Veeva RIM system and author CTD Module 3 documents, focusing on analytical sections

Required Qualifications:

• Over 6 years of experience in pharmaceutical/biotech CMC and analytical development
• Experience with regulatory submissions and familiarity with GMP and global regulatory guidelines
• Strong technical writing skills with experience in CTD Module 3 documentation and Veeva RIM system
• Ability to collaborate effectively with stakeholders and manage multiple priorities
• Preferred experience with global regulatory submissions and external manufacturing/testing partners