Manager, Global Labeling Strategy

Medical and Regulatory Affairs

icon-location-marker Princeton - NJ - US
icon-location-marker Uxbridge - GB
Posted 45 days ago Full_time R1521784

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.

Summary

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.

Position Responsibilities

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

Required

Bachelors degree in a Life Science

Desired Experience

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.