Regulatory Documentation Lead - eDMS and Publishing

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

Benefits offered by this job

Hybrid work model

Job summary

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

The successful candidate will have a BS/BA with 4+ years of regulatory documentation experience, expertise in Acrobat and ISI toolbox, and proven training and cross-functional

Qualifications

• BS/BA degree required.
• 4+ years in regulatory documentation.
• Experience with document management repositories and publishing workflows.

Responsibilities

• Lead GSRD and external authors for eDMS processes and document publishing.
• Direct documentation workstreams for submission-level documents including model summaries.
• Lead training across GSRD for internal and external staff; provide troubleshooting in eDMS and publishing workflows.
• Advise cross-functional partners on SRC formatting and publishing of protocol and submission documents.
• Define submission-ready requirements for externally authored documents; manage remediation and publishing.
• Coordinate, curate and author select protocol and submission documents incorporating scientific and regulatory input.
• Drive continuous improvement to enhance quality and efficiency of regulatory documentation processes.

Skills

Leadership

Training

Troubleshooting

Communication

Interpersonal skills

Project coordination

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 workstreams for regulatory filings, HA responses and complex clinical protocols, including strategies for eDMS, submission-readiness formatting and publishing of regulatory documents across protocol and submission types.

The successful candidate will have a BS/BA with 4+ years of regulatory documentation experience, expertise in Acrobat and ISI toolbox, and proven training and cross-functional