Documentation Analyst

81728TSR 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 W2Responsibilities:Responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brandsThis 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 brandsThis candidate is expected to have a good understanding of regulatory guidelinesManage document preparation of CMC regulatory submission documents to standards and ensure final document compliance to ensure submission content meets formatting requirementsManage the logistical process in the authoring system for CMC regulatory submissionsThis 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 teamsFacilitate data verification to ensure accuracy of submission data following the internal standard operating procedureAuthor CMC elements of regulatory filings with supervisionParticipate 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 necessaryMust be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines

Created: 2025-03-01