Bristol myers squibb
Manager, Document Management
Overview
The Manager, Document Management - based in Warsaw - leads end-to-end documentation specialist’s workstreams for regulatory filings, HA response or complex clinical protocols including strategies for eDMS processes within scope, submission-readiness formatting, PDF processing and publishing of regulatory documents across protocol and submission document types.
About Bristol myers squibb
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases.
Requirements & Eligibility
- Minimum of BS/BA degree with 4+ years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing work flows
- Subject matter expertise in desktop applications, word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents
- Subject matter expertise in Acrobat and ISI toolbox usage for creation of complex PDF compilation and remediation of PDF documents for eCTD compliance
- Subject matter expertise in the document management system for assembly and management of complex regulatory documents
- Deep understanding of document publishing processes across GSRD document types
Key Responsibilities
- Lead and provide strategic direction to GSRD and external authors for eDMS processes within scope and document publishing of protocol and submission documents
- Lead and provide strategic direction on documentation specialist workstream for all submission level documents including model 2 summaries and HA submission driving submissions and approvals
- Lead training across GSRD for new internal and external staff and provide troubleshooting assistance to GSRD personnel and external authors
- Provide strategic direction and subject matter expertise to cross-function business partners on SRC formatting and publishing of protocol and submission related documents
- Lead cross functional business partners in defining submission-ready requirements for externally authored regulatory documents
- Independently manage collection and review of ICH non-data driven appendices for CSRs
- Provide strategic direction and coordinate GSRD model document updates and system approval processes
- Participate in continuous improvement workstreams to enhance quality and increase efficiency of document processes
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