Regulatory Document Management Lead – eDMS & Publishing

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 175,000 - 212,000; Full time

Benefits offered by this job

Hybrid work model

Onsite at facility

Job summary

Bristol Myers Squibb in Warsaw is seeking a Manager, Document Management to lead end-to-end documentation workstreams for regulatory filings, HA responses, and complex clinical protocols, including eDMS strategies and publishing of protocol/submission documents.

The role emphasizes training across GSRD, cross-functional collaboration, and ensuring submission-readiness formatting and publishing quality. Onsite with hybrid work, 50%+ in the office.

Qualifications

• Minimum of BS/BA degree with 4+ years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing workflows.
• 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
• Demonstrated training and troubleshooting skills in eDMS, submission readiness formatting and document publishing workflows.
• Ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills.
• Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.

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. Provide troubleshooting assistance to GSRD personnel and external authors in the eDMS, Core Template, submission readiness formatting and publishing work
• 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 submission readiness remediation, eDMS import and publishing of externally authored Word and PDF files.
• Independently manage collection and review of ICH non-data driven appendices for CSRs. Direct cross functional business partners (CTAs, Protocol Managers) in defining submission-ready requirements for ICH non-data driven appendices.
• Provide strategic direction and coordinate GSRD model document updates and system approval processes.
• Provide strategic direction and independently coordinate, compile and/or author select protocol and submission documents types ensuring integration of scientific and regulatory input from team members
• Participate in continuous improvement workstreams to enhance quality and increase efficiency of document processes, including automated and digital solutions for development of regulatory documentation.

Skills

Regulatory docs

eDMS expertise

Training & troubleshooting

Timeline management

Cross-functional collaboration

Education

BS/BA in life sciences or related field

Tools

Adobe Acrobat

ISI Toolbox

Word macros

PDF publishing workflow

Job description

Bristol Myers Squibb in Warsaw is seeking a Manager, Document Management to lead end-to-end documentation workstreams for regulatory filings, HA responses, and complex clinical protocols, including eDMS strategies and publishing of protocol/submission documents.

The role emphasizes training across GSRD, cross-functional collaboration, and ensuring submission-readiness formatting and publishing quality. Onsite with hybrid work, 50%+ in the office.