Senior Regulatory Documents Lead, eDMS & Publishing

Bristol Myers Squibb EU Policy; Warszawa; On-site; PLN 175,000 - 212,000; Full time

Benefits offered by this job

Hybrid work model

On-site in Warsaw

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, PDF processing and publishing across protocol and submission documents.

The role focuses on directing GSRD and external authors, coordinating submission-ready requirements, and training staff, with hybrid work and at least 50% onsite attendance.

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.

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

Organizational skills

Communication

Facilitation

Interpersonal skills

Training

Troubleshooting

Education

BS/BA degree

Tools

Acrobat

ISI toolbox

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, PDF processing and publishing across protocol and submission documents.

The role focuses on directing GSRD and external authors, coordinating submission-ready requirements, and training staff, with hybrid work and at least 50% onsite attendance.