Manager, Global Scientific and Regulatory Documentation

Bristol Myers Squibb; Warszawa; Hybrid; PLN 206,000 - 249,000; Full time

Benefits offered by this job

Hybrid work model

Onsite facility

Job summary

Bristol Myers Squibb is seeking a Manager, Global Scientific and Regulatory Documentation based in Warsaw. You will lead the creation of regulatory documents for submissions, coordinating scientific, medical, and regulatory input from cross-functional teams.

The role emphasizes drafting for IB, CSR, and clinical protocols, with a hybrid work model requiring at least 50% onsite presence at the Warsaw facility.

Qualifications

• Regulatory documentation experience in pharmaceutical settings.
• Proven ability to author regulatory documents (IB, CSR, protocols).
• Strong writing and communication skills across scientific disciplines.
• Ability to manage timelines and coordinate cross-functional input.
• Understanding of global drug development processes.
• Familiarity with document publishing workflows.

Responsibilities

• Coordinate and author regulatory documents for submissions.
• Use AI-assisted/document tools to improve efficiency and quality.
• Plan and manage timelines for all document components.
• Contribute to document strategy sessions and messaging.
• Maintain document prototypes and shells.
• Ensure compliance with internal/external processes and resolve issues.

Skills

Regulatory documentation

Strong writing skills

Cross-functional collaboration

Timeline management

Data interpretation

Document publishing basics

Education

PharmD/PhD or Master’s/Bachelor in a relevant science

Tools

Document management system

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, Global Scientific and Regulatory Documentation - based in Warsaw - l eads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies. Provides support for fit-for-purpose regulatory documents (clinical pharmacology, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.

Objective: To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of scientific, medical, and regulatory input from cross-functional team members.

Responsibilities

• Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.

• Use document development tools that incorporate artificial intelligence, structured content, programming features, and other evolving approaches to enhance efficiency, quality, and speed of processes.

• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.

• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.

• Maintain document prototypes and shells.

• Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.

• Review and edit documents as required.

Qualifications

• PharmD/PhD in a relevant scientific discipline or Master’s/Bachelor’s degree

• 2-4 years of regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.

• Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.

• Ability to analyze and interpret complex data from a broad range of scientific disciplines.

• Understanding of global pharmaceutical drug development.

• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

• Working knowledge of a document management system and basic knowledge of the document publishing process.

T** his 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.

Compensation Overview

Warsaw - PL: zł205,850 - zł249,445

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 to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodations/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin 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 qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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 this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1601854 : Manager, Global Scientific and Regulatory Documentation