Associate Director, Global Labeling Strategy

Princeton, NJ, United States
Aug 23, 2020
Required Education
Masters Degree/MBA
Position Type
Full time
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.

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

Experience Required:
  • Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC) or Bachelor of Life Sciences and at least 7 years of Labeling / Regulatory Experience
  • 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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.