Manager, Document Management

Bristol-Myers Squibb; Warszawa; On-site; 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 documentation workstreams for regulatory filings and eDMS publishing. You will collaborate with internal teams and external authors to ensure submission-ready documents.

The role requires hands-on expertise in eDMS, Acrobat, ISI Toolbox, and model documents, plus training and cross-functional leadership to drive quality and efficiency in regulatory documentation processes.

Qualifications

• BS/BA degree with 4+ years of regulatory documentation experience.
• Subject matter expert in desktop applications, word template macros, and model documents for eCTD compliance.
• Expert in Acrobat and ISI toolbox for complex PDF compilation and remediation for eCTD.
• Deep understanding of the document management system for assembling and managing complex regulatory documents.
• Strong knowledge of document publishing processes across GSRD document types.
• Proven training and troubleshooting skills in eDMS, submission readiness formatting and publishing workflows.
• Ability to manage timelines and quality with strong organizational, communication, facilitation and interpersonal skills.

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 workstreams 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

Submission readiness

Cross-functional collaboration

Training

Project management

Communication

Education

BS/BA degree

Tools

Acrobat

ISI toolbox

eDMS

PDF publishing

Model documents

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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.

Work Environment

Unikely Interesting Work, Life-changing Careers With a single vision as inspiring you Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.