What are the responsibilities and job description for the Documentation Analyst position at TSR Consulting Services, Inc.?
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TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a Documentation Analyst.
Must possess working knowledge of regulatory CMC submissions. Experience in Cell Therapy is a plus.
MUST have a clear understanding of CMC submission structure with respect to the different Modules (1,2,3) and respective section numbering within those modules.
Pay: $38-39/hour W2
Responsibilities:
- Responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands
- This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands
- This candidate is expected to have a good understanding of regulatory guidelines
- Manage document preparation of CMC regulatory submission documents to standards and ensure final document compliance to ensure submission content meets formatting requirements
- Manage the logistical process in the authoring system for CMC regulatory submissions
- This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams
- Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure
- Author CMC elements of regulatory filings with supervision
- Participate in various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary
- Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines
Salary : $38 - $39
