Director, Global Scientific and Regulatory Documentation , Safety and Lifecycle Management

Bristol-Myers Squibb; Uxbridge; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Director to lead a team of Scientific Writers in the creation of critical safety reports for regulatory submissions. This role offers the chance to influence global pharmaceutical documentation processes while working in a dynamic and supportive environment. You will guide a talented team, ensuring high-quality documentation that meets stringent regulatory standards. If you're passionate about transforming lives through science and have a proven track record in regulatory documentation, this opportunity could be your next career-defining move.

Benefits

Competitive Benefits

Flexible Work Environment

Professional Development Opportunities

Health and Wellness Programs

Qualifications

• 10+ years in pharmaceutical regulatory documentation required.
• Experience in writing high-quality regulatory documents essential.
• Proven leadership in managing large project teams.

Responsibilities

• Lead a team of scientific writers for regulatory submissions.
• Ensure compliance with Health Authority requirements.
• Develop training and maintain documentation standards.

Skills

Regulatory Documentation

Project Management

Cross-Functional Collaboration

Communication Skills

Mentoring

Organizational Skills

Education

PharmD/PhD/MD in relevant scientific discipline

Master's/Bachelor’s degree with 10 years experience

Tools

Documentation Software

Project Management Tools

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. Read more: careers.bms.com/working-with-us .

As the Director, Global Scientific and Regulatory Documentation, Safety and Lifecycle Management, you will lead a team of Scientific Writers responsible for writing a variety of safety reports for Regulatory Submissions (eg Safety Aggregate Reports, Risk Management Plans) during development, submission, approval, and life cycle management of products in the BMS pipeline.

Duties/Responsibilities

• Lead a team of scientific writers who author and review safety reports for global regulatory submissions, including, but not limited to Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), Risk Management Plans (RMPs) ensuring these are of high quality based upon good documentation principles within established optimum timelines
• Ensure that the Book of Work for Safety Aggregate reports and other safety-related documents are delivered according to schedule to ensure compliance with Health Authority requirements
• 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
• Establish and maintain documentation standards, templates, and best work practices that are consistent with internal and external guidelines for regulatory documentation; facilitate the development of innovative solutions to resolve issues
• Set clear performance standards, provides feedback and coaching, identifies and fulfils training needs, and holds the group members accountable for key deliverables. Manages performance together with relevant cross-functional project team leaders
• Recruit and train scientific writers for this scope of documentation, as needed
• 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 behaviours that lead to meaningful synergies and superior business performance
• Drive simplification of processes and implementation of innovative solutions

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 a large group/project team with solid behaviours in cross-functional collaboration and communication
• Significant experience in writing high-quality regulatory documentation, including high-level summary documents (preferably safety-reports)
• Experience in managing project teams and process workflows and exhibits solid behaviours 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 junior colleagues in a group
• Good understanding of global pharmaceutical drug development, Good Pharmacovigilance Practices 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

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.

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.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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