CMC Technical Writer
Job Summary
Working remotely on a contract basis, the CMC Technical Writer will critically review and translate data from external CDMOs into scientific reports, author regulatory content, and finalize source documents to support drug development and submissions.
Key Responsibilities
- Translate data and results from CDMOs into scientific reports with summaries and conclusions for regulatory submissions
- Review and finalize technical reports from CDMOs to support program deliverables
- Assist with document organization and finalization, including analytical methods and validation reports
Required Qualifications
- 12+ years of experience in the pharmaceutical or biotechnology industry with CMC expertise
- Strong scientific background with technical writing skills
- Understanding of phase-appropriate documentation and regulatory guidelines
- Ability to simplify complex scientific terminology for clear communication
- Proficiency with document management tools
Complete Job Description
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