Senior 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: To 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

• Authors complex clinical documents (e.g., Investigator's Brochures, Protocols, Phase 2/3 Clinical Study Reports, briefing documents, Common Technical Document summary documents, responses to Health Authority queries) for timely submission to health authorities worldwide according to good documentation principles (organization, clarity, scientific standards).
• Consistency between text and tabular presentations or graphical displays
• Compliance with BMS documentation standards and worldwide regulatory requirements
• Use document development tools incorporating 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.
• Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and 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:
• Optimal communication between authoring team and development team members
• Coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
• Timely completion and high quality of assigned documents
• Review and edit documents as required.
• Serve as a liaison for external documentation support (when required), prepare specifications for the work, and ensure maintenance of good documentation principles as well as BMS documentation standards.
• Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Qualifications

• PharmD/PhD in a relevant scientific discipline or Master’s/Bachelor’s degree with approximately 5 years of pharmaceutical regulatory documentation experience. All PhD in biological sciences and PharmD candidates are considered.
• 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.
• Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• 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: zł230,560 - zł279,377. 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.

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.