Analytical CMC Technical Writer

Job Summary

Seeking an experienced Analytical CMC Technical Writer for a remote contract position, who will provide scientific leadership in analytical development and quality control activities, contribute to regulatory submissions, and manage documentation workflows within the Veeva RIM system.

Key responsibilities

• Provide scientific leadership for phase-appropriate DS/DP analytical development and quality control activities
• Contribute to the development of analytical specifications and control strategies in collaboration with internal teams and external partners
• Author, review, and edit CTD Module 3 documentation for drug substance and drug product, focusing on analytical content and compliance

Required qualifications

• Minimum 6 years of experience in pharmaceutical or biotechnology CMC and analytical development
• Demonstrated experience supporting regulatory submissions and CMC documentation activities
• Strong working knowledge of GMP requirements and global regulatory guidelines
• Experience with analytical method development, validation, transfer, and stability testing
• Working knowledge of Veeva RIM systems and documentation workflows