Associate Director, Global Labelling Strategy

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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.

Key Responsibilities

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.

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Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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