Manager, Global Scientific and Regulatory Documentation

Position Summary

Leads 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: Coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross‑functional team members.

Responsibilities

• Coordinate and author regulatory documents (e.g., Investigator’s Brochures, development safety update reports, periodic benefit‑risk evaluation reports, clinical study reports, 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 with approximately 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.

Compensation Overview

Warsaw – PL: zł205,850 – zł249,445 (full‑time employee)

Additional incentive cash and stock opportunities may be available based on eligibility. The final compensation will be determined based on demonstrated experience and applicable pay equity principles.

Equal Opportunity & Accessibility Statement

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

BMS is dedicated to ensuring 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, please contact Wyświetl e-mail na click.appcast.io. For accessibility information, visit careers.bms.com/eeo-accessibility.