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Director, Global Labelling Strategy

Posted on Apr 6, 2021 by Bristol-Myers Squibb

Princeton, NJ 08540
Immediate Start
Annual Salary

Job Description
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.

The Director, Global Labelling Strategy has oversight over a complex Program or Therapeutic Area (TA) ensuring 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 are done in a timely manner. Position will also serve as Global Labeling Lead for assigned projects.
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

Reference: 1152693380

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