Quality Assurance Technical Writer
4 days ago
Key Responsibilities:
- Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
- Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
- Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.
Requirements:
- Degree in Pharmacy, Chemistry, Biology, or a related field.
- Previous experience as a scientist in analytical development CMC.
- At least 5 years of technical writing experience in CMC regulatory submissions.
Salary: $90,000 - $110,000 per year, depending on location and experience.
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