Manager, Document Management

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

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. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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.

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.

Qualifications

• 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
• Demonstrated training and troubleshooting skills in eDMS, submission readiness formatting and document publishing work flows.
• 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

Please note that this position is not a remote working opportunity and is based in the local BMS office, following a hybrid work model with at least 50% onsite attendance at your assigned facility.

#LI-Hybrid

Compensation Overview:

Warsaw - PL: zł174,980 - zł212,026

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned