Director, Global Scientific and Regulatory Documentation, Content Strategy

Bristol Myers Squibb; Warszawa; On-site; PLN 542,000 - 657,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland, seeks a Director of Global Scientific and Regulatory Documentation, Content Strategy to lead the development and governance of regulatory documentation. You will guide writer assignments, mentor teams, and drive process improvements that accelerate the BMS pipeline.

The role emphasizes managing complex projects, collaborating across functions, and advancing GenAI-enhanced documentation practices to meet global regulatory standards.

Qualifications

• PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with a minimum of 10 years in pharmaceutical regulatory documentation.
• Proven record in managing group/project teams with cross-functional collaboration.
• Significant experience in writing regulatory documentation, including high-level summary documents (preferably clinical).
• Experience in managing project teams and process workflows with cross-functional collaboration and communication.
• Experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success.
• Experience in mentoring and professional development of colleagues in a group.
• Advanced understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
• Experience in the areas of state of the art documentation processes and technology.

Responsibilities

• Work with Therapeutic Area Lead to optimize the delivery of content and documentation that supports the BMS pipeline.
• Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support for documents not covered adequately by in-house resources.
• Review regulatory, clinical, and safety documentation according to good documentation principles (organization, clarity, scientific standards) and ensure consistency between text and tables.
• Recruit and train scientific writers for this scope of documentation, set clear performance standards, provide feedback and coaching, and hold team accountable for key deliverables.
• Support skillset development for scientific writers as needed for BMS pipeline, regulatory developments, and other opportunities.
• Lead or contribute to innovation projects applying GenAI to automate and optimize regulatory writing processes.
• Serve as a GenAI champion within GSRD and evolve authoring workflows and standards.
• Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria for external documentation support when needed.
• Ensure regular entry of meta data to support departmental metrics and analytics.
• Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles.
• Develop training on regulatory documents across disciplines and provide to writers regardless of reporting relationship.
• Facilitate proactive sharing of knowledge and key learnings within the group and across functions.
• Interface across multiple functions to mediate conflict resolution and promote meaningful synergies.

Skills

Cross-functional collaboration

Regulatory writing leadership

Mentoring and coaching

GenAI proficiency

Education

PharmD/PhD/MD or advanced degree

Tools

GenAI

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.

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.

Position Summary

Supports the establishment and ongoing development of team of scientific writers working across therapeutic areas. Guides writer assignments and development plans, and mentors scientific writers in a variety of content and document assignments. Takes initiative to create and implement process improvements and behavioral changes that support the quality and content flow of information supporting the BMS pipeline.

Duties/Responsibilities

• Work with Therapeutic Area Lead to optimize the delivery of content and documentation that supports the BMS pipeline.
• Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support for documents not covered adequately by in-house resources.
• Review regulatory, clinical, and safety documentation 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
• Recruit and train scientific writers for this scope of documentation, as needed - Set clear performance standards, provides feedback and coaching, identifies and fulfills training needs, and holds the group members accountable for key deliverables. Provides performance evaluation input.
• Support skillset development for scientific writers as needed for BMS pipeline, technological advancements, regulatory developments, and other opportunities
• Lead or contribute to innovation projects applying GenAI to automate and optimize regulatory writing processes
• Serve as a GenAI champion within GSRD
• Supports evolution of authoring workflows, standardization, and efficiency across documents
• Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support for documents not covered adequately by in-house resources.
• Ensure regular entry of meta data to support departmental metrics and analytics.
• Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles.
• Develop training on regulatory documents from a variety of disciplines and provide to writers regardless of reporting relationship in matters pertaining to documentation processes and principles. Develop resources for writing team to ensure quality standards.
• Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
• Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior business performance.

Qualifications

• PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with a minimum of 10 years in pharmaceutical regulatory documentation. - Prior regulatory documentation leadership in the development and approval of new drug applications/dossiers is preferred. All PhD in biological sciences and PharmD candidates are considered.
• A proven record in managing group/project team with solid behaviors in cross-functional collaboration and communication.
• Significant experience in writing high-quality regulatory documentation, including high-level summary documents (preferably clinical).
• Experience in managing project teams and process workflows and exhibits solid behaviors in cross-functional collaboration and communication.
• Experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success.
• Experience in mentoring and professional development of colleagues in a group.
• Advanced understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
• Experience in the areas of state of the art documentation processes and technology.

Compensation Overview

Warsaw - PL zł541, 840 - zł656,574

Warsaw - PL zł541,840 - zł656,574

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 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 [e-mail]. 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.

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 https //careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. 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.

R1603119 Director, Global Scientific and Regulatory Documentation, Content Strategy