![]() Serving as document management archivist, in developing and providing input to the establishment of procedures governing document retirement.Coordinates and leads document exchange, scanning, quality control, assembly and committing of all regulatory authority submission, compliance, correspondence, advertising and promotional documents into a global electronic archival system for product purchase activities, integrations and Regulatory projects.Executes regulatory documentation searches to extract data and statistics, export documentation for the on-going operations/projects of the Regulatory Affairs and the Global Document Management Departments which includes litigation's, due diligence's, integrations, audits, and co-partner activities.Problem-solve, interact, communicate, and address daily issues from colleagues and customers regarding document management software and records management responsibilities.Executes regulatory documentation searches to extract data and statistics, export documentation for the on-going operations/projects of the Regulatory Affairs and the Global Document Management Departments which includes litigations, due diligences, integrations, audits, and co-partner activities.Reviewing all eTMF study, country and site binders periodically for document linkage and visibility within the appropriate binder(s) and cross referencing existing documentation and new submissions for the reduction of duplication and/or erroneous documents within the eTMF system.Experience processing documentation, handling PII/SII (Personally Identifiable Information/ Sensitive Identifiable Information).: Direct experience developing, implementing, and managing document management systems.Demonstrated use of printing, scanning and filing systems. ![]()
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