Documentation Analyst

Location: Remote
Compensation: To Be Discussed
Staff Reviewed: Tue, Aug 27, 2024
This job expires in: 19 days

Job Summary

A company is looking for a Documentation Analyst.

Key Responsibilities:
  • Manage document preparation of CMC regulatory submission documents
  • Coordinate reviews, triage comments, and facilitate consensus meetings
  • Author CMC elements of regulatory filings with supervision

Required Qualifications:
  • Bachelor's degree in a relevant discipline with 4-7 years experience or Master's degree with 1-3 years experience
  • Working knowledge of regulatory CMC submissions
  • Experience in Cell Therapy and CMC are a plus

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