Manager, Global Scientific and Regulatory Documentation

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

Job summary

Bristol Myers Squibb in Warsaw is seeking a Manager, Global Scientific and Regulatory Documentation to lead the authoring of regulatory documents and coordinate cross-functional inputs for submissions across markets. The role supports development, submission, approval, and lifecycle management of products in the BMS pipeline.

The position requires 2–4 years in regulatory documentation, strong writing and organizational skills, and a hybrid work model with at least 50% onsite attendance at the

Qualifications

• Strong writing skills in authoring regulatory documents (IB, CSR, safety reports) and coordinating cross-functional input.
• Experience with regulatory documentation for global submissions.
• Ability to analyze complex scientific data and ensure quality and timeliness.

Responsibilities

• Coordinate and author regulatory documents for submissions and approvals across markets.
• Use advanced document tools to enhance efficiency, quality, and speed.
• Plan and manage timelines for all components of assigned documents.
• Participate in document strategy sessions and ensure messaging consistency.
• Review and edit documents to ensure accuracy and compliance.

Skills

Regulatory writing

Cross-functional collaboration

Complex data interpretation

Timeline management

Education

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

Tools

Document management system

Document publishing process

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.

#LI-Hybrid

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 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] . V