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Bristol Myers Squibb
,
Uxbridge, Greater London
Director, Global Labeling Lead
Overview
Job Description
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. Key Responsibilities Oversight over a complex Program or Therapeutic Area (TA) Matrix Leader ensuring that Program Deliverables are met and labeling claims across program / TA are consistent Train, mentor and provide guidance for other Global Labeling Leads 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), 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 Desired Experience 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 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 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.