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The Associate Director, Global Labelling Strategist Lead, is responsible for the development and implementation of labelling content (CCDS, USPI and EU SmPC) and strategy of multiple assigned products, with limited supervision and guidance.

Policy Influence & Knowledge Sharing

• Identifies and advocates for regulatory policy change that could impact labelling.
• Provides guidance and Train other Global Labelling Leads
• Contributes to procedural documents (e.g. Policies, SOPs, working instructions, job aids)

Qualifications

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience
• Bachelor of Life Sciences and at least 7 years of Labelling/Regulatory Experience

Knowledge and Experience

• Knowledge of Global Labelling Guidance, labelling tools, Drug Development and Commercialization of prescription medicines.
• Labelling expertise in major regions USA FDA, EMA.
• Detailed knowledge of procedures, regulatory requirements and GxP.
• Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and their implications.
• Ability to assess and manage regulatory implications of product strategy related to labelling development.
• Demonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment.
• Leadership skills to influence and guide Subject Matter Experts from various disciplines.
• Experience in managing high to medium complex projects.
• Excellent project management 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

Global Labelling Strategy & Execution

• Leads labelling strategy in line with the overall regulatory strategy by providing labelling expertise (labelling regulations, competitor analyses) for high or medium complex projects
• Authors new/revised CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with limited supervision and guidance.
• Employs strong project management skills to coordinate global labelling sub-functions to ensure timely end to end label creation and timely Health Authority submission and has key role in label negotiations with Health Authorities (leading or in conjunction with GRL).
• May assist with the development of Target Product Labelling (TPL) for new assets.

Cross-function Collaboration & Process Optimization

• Leads Labelling Strategy Team (LST).
• Works closely with TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST with management support to ensure seamless labelling strategy execution
• Coordinates labelling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.
• Supports Country Regulatory Managers in timely labelling submissions, implementations globally.
• Reviews country labels to ensure labelling compliance and assess labelling differences to CCDS.
• Supports responses to labelling related inquiries from Global Health Authorities and related to inspection activities.
• Looks for opportunities for continuous improvement in processes, and technology solutions

Policy Influence & Knowledge Sharing

• Identifies and advocates for regulatory policy change that could impact labelling.
• Provides guidance and Train other Global Labelling Leads
• Contributes to procedural documents (e.g. Policies, SOPs, working instructions, job aids).

Qualifications

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience
• Bachelor of Life Sciences and at least 7 years of Labelling/Regulatory Experience.

Knowledge and Experience

• Knowledge of Global Labelling Guidance, labelling tools, Drug Development and Commercialization of prescription medicines.
• Labelling expertise in major regions USA FDA, EMA.
• Detailed knowledge of procedures, regulatory requirements and GxP.
• Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and their implications.
• Ability to assess and manage regulatory implications of product strategy related to labelling development.
• Demonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment.
• Leadership skills to influence and guide Subject Matter Experts from various disciplines.
• Experience in managing high to medium complex projects.
• Excellent project management 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.

LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.