Senior Manager, Global Scientific and Regulatory Documentation

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.

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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 [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 with approximately 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.

#LI-Hybrid

If you come across a role that intrigues you but doesn’t 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.

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.

Uniquely Interesting Work, Life-changing Careers 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 accommodations/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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

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If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1601856 : Senior Manager, Global Scientific and Regulatory Documentation