Document Management Lead — Regulatory Publishing (Hybrid)

Biopharma Careers; Warszawa; On-site; PLN 175,000 - 212,000; Full time

Benefits offered by this job

Hybrid work model

On-site Warsaw 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, submission readiness formatting, and publishing across document types.

The role requires 4+ years in regulatory documentation, expertise in Acrobat/ISI toolbox, and strong cross-functional leadership. Hybrid work with 50% onsite attendance is required at the Warsaw facility.

Qualifications

• BS/BA degree required with 4+ years regulatory documentation experience.
• Expertise in desktop applications and word template macros for eCTD submissions.
• Proficient in Acrobat and ISI toolbox for complex PDFs and eCTD compliance.
• Experience with eDMS, submission readiness formatting and document publishing workflows.
• Strong training and troubleshooting skills for eDMS and document publishing workflows.

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 documentation

eDMS

PDF publishing

Cross-functional collaboration

Training

Project management

Education

BS/BA degree with 4+ years regulatory documentation experience

Tools

Acrobat

ISI toolbox

Document management system

PDF remediation

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, submission readiness formatting, and publishing across document types.

The role requires 4+ years in regulatory documentation, expertise in Acrobat/ISI toolbox, and strong cross-functional leadership. Hybrid work with 50% onsite attendance is required at the Warsaw facility.