Director, Global Labeling Strategy Team Lead
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
- Responsible for a team of therapeutically-aligned Global Labeling Strategists (one or more therapeutic areas)
- Provides leadership and development for direct reports
- Manages direct reports to ensure coverage for assigned therapeutic areas and products
- Oversight over a complex Program or Therapeutic Area (TA) and working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical
- Ensures that Program Deliverables are met and labeling claims across program / TA are consistent
- Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals
- Identifies opportunities to influence regulatory policy and climate with respect to labeling content
- Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory Strategy by providing labeling expertise (labeling regulations, internal processes and competitor analyses) for CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure)
- Serves as primary contact for cross-functional Labeling Team Member (CFLT), e.g., Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally
- Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality
- Ensures effective planning of all cross-functional labeling activities
- Reviews country labels to ensure labeling compliance
- Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.
- Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 10 years of Labeling (CCDS / USPI / SmPC) / Regulatory Experience; Bachelor of Lifesciences with at least 15 years of Labeling / Regulatory Experience; has at least experience with one NME submission globally
- Experience in people management and developing and managing high performing teams, including remote team members
- Knowledge of Global Labeling Guidances, Drug Development and Commercialization of prescription medicines
- Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS
- Proven ability to understand regulatory implications of product strategy related to labeling development, assessment and management
- Demonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment
- Proven Matrix leader with excellent problem-solving skills
- Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making
- Proven ability to develop and manage a highly competent and technically skilled team
- Experience in managing high to medium complex projects
- Excellent verbal and written communication skills
- Keen attention to detail and accuracy
- Ability to assimilate clinical and scientific information and present it in a concise manner
- Ability to think creatively and good excellent problem-solving skills
Ideal Candidates Would Also Have advanced academic training (PharmD, PhD, MD) highly desirable
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.