Manager, Global Scientific and Regulatory Documentation

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. Read more: 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 scientific medical and regulatory input from cross-functional team members.

Responsibilities

• Coordinate and author regulatory documents eg Investigators 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 Masters/Bachelors 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.

This 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

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 employees 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.

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With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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: Protection

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