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Analytical CMC Technical WriterVirtualVocations • Hialeah, Florida, United States
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Analytical CMC Technical Writer

Analytical CMC Technical Writer

VirtualVocations • Hialeah, Florida, United States
5 days ago
Job type
  • Full-time
Job description
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
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Analytical CMC Technical Writer • Hialeah, Florida, United States

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