Analytical CMC Technical Writer

Job Summary

Seeking a remote Analytical SME & CMC Technical Writer, this contract position will drive analytical strategies, author critical regulatory submissions, and manage documentation workflows while aligning with East Coast working hours.

Key responsibilities

• Provide scientific leadership for drug substance and drug product analytical development and lifecycle management
• Review and author Quality Agreements, Statements of Work, study protocols, and batch/stability data
• Author, review, and edit CTD Module 3 documents, focusing on analytical sections and Health Authority responses

Required qualifications

• Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline (Doctorate preferred)
• 6+ years of pharmaceutical/biotech CMC and analytical development experience
• Demonstrated experience in technical writing and authoring regulatory submissions
• Strong familiarity with GMP regulations and global guidelines (ICH, FDA, EMA, USP, EP)
• Proven experience with global submissions (IND, CTA, NDA, MAA) is preferred