Senior Manager, Global Scientific and Regulatory Documentation

Bristol-Myers Squibb; Poland; Hybrid; PLN 207,000 - 253,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Manager to lead document strategy and authoring for global regulatory submissions. You will coordinate and produce critical regulatory documents across disciplines, ensuring consistency and compliance while supporting fast information flow during development and approvals.

The role requires managing timelines, collaborating with cross-functional teams, and maintaining document prototypes and shells in a hybrid on-site 50% model.

Qualifications

• PharmD/PhD or Master’s/Bachelor’s degree in a relevant scientific field.
• 5 years of pharmaceutical regulatory documentation.
• Strong writing and editing skills for regulatory documents (IB, CSR, etc.).
• Ability to interpret complex data from diverse scientific disciplines.
• Understanding of global drug development and regulatory documentation requirements.
• Excellent time management and cross-functional collaboration.

Responsibilities

• Authors complex clinical documents (IB, Protocols, CSR, etc.) for submission to health authorities worldwide.
• Participate in document subteams and manage timelines for all components.
• Engage in document strategy sessions, messaging and flow for projects.
• Maintain document shells and prototypes; ensure consistency and quality.
• Coordinate with external documentation support when required and ensure standards.

Skills

Strong writing skills

Data interpretation

Regulatory documentation

Timeline management

Cross-functional collaboration

Education

PharmD/PhD or Master’s/Bachelor’s degree

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.

The Senior Manager, Global Scientific and Regulatory Documentation - based in Warsaw - 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 [eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) 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, in compliance with BMS documentation standards and worldwide regulatory requirements, 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.
• 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.
• Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
• Leads and influences 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
• 5 years of pharmaceutical 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.
• Demonstrated 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.
• 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: zł230,560 - zł