Director, Global Labeling Strategy

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us

Key Responsibilities

• Provides oversight over a complex program for one or more Therapeutic Area (TA)(s), or high-priority asset(s) and working closely with their stakeholders.
• Ensures that labeling strategies aligns with the regulatory requirements globally and managing relationship with senior stakeholders.
• Mentor and develop team members to foster a high performing culture, as applicable.
• Ensures that Program Deliverables are met and labeling claims across program / TA are consistent.
• Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.
• Serves as primary contact for Labeling Strategy Team (LST), eg Global Regulatory Lead (GRL), Safety Management Team Lead (SMTL), 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.
• 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) and Target Product Labeling, as applicable.
• Identifies opportunities to influence regulatory policy and climate with respect to labeling content.
• 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 and assess labeling differences to CCDS.
• Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.

DEGREE REQUIREMENTS

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.

Key Competency Requirements

• 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: (nice to have skills; plain text - NO bold; recommend using bullets, ideally no more that 3 bullet points)

• Advanced Academic Training (PharmD, PhD, MD) highly desirable.

• Provides oversight over a complex program for one or more Therapeutic Area (TA)(s), or high-priority asset(s) and working closely with their stakeholders.
• Ensures that labeling strategies aligns with the regulatory requirements globally and managing relationship with senior stakeholders.
• Mentor and develop team members to foster a high performing culture, as applicable.
• Ensures that Program Deliverables are met and labeling claims across program / TA are consistent.
• Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.
• Serves as primary contact for Labeling Strategy Team (LST), eg Global Regulatory Lead (GRL), Safety Management Team Lead (SMTL), 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.
• 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) and Target Product Labeling, as applicable.
• Identifies opportunities to influence regulatory policy and climate with respect to labeling content.
• 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 and assess labeling differences to CCDS.
• Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities