Bristol-Myers Squibb Company

Associate Director Labeling Lead

Location
Princeton, NJ, United States
Posted
Apr 23, 2019
Ref
R1514585
Required Education
Masters Degree/MBA
Position Type
Full time
Position 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 high or medium complex projects in the Development and 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

Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities

Reviews country labels to ensure labeling compliance

Train and provide guidance for other Global Labeling Leads as needed

Participates in / 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

Required Experience

Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC)

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

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 high to medium complex projects

Excellent project management, 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

working in documentum based systems

Development Value

Opportunities to develop a high performing team, participate in enterprise labeling initiatives