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Documentation Analyst

2 months ago

Aurora CO United States VirtualVocations Full time
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