Medical and Regulatory Affairs
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Global Labeling Lead has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure.
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) for medium to low complex projects in the Lifecycle Management (LCM) projects
Serves as primary contact for cross-functional Labeling Team Member (CFLT), eg 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
Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals
Bachelors degree in a Life Science
Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of LifeSciences with at least 2 years of Labeling / Regulatory Experience
Good Understanding of Drug Development and Commercialization of prescription medicines
Ability to understand regulatory implications of product strategy related to labeling development, assessment and management
Ability to develop strong and positive working relationships across diverse teams and within a global environment
Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making
Experience in managing 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
Labeling Experience (CCDS / USPI / SmPC) is desirable
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 the resources to pursue their goals, both at work and in their personal lives.