Senior Director, Global Labeling Strategy Team Lead

Job title:

Senior Director, Global Labeling Strategy Team Lead

Company

Bristol-Myers Squibb

Job description

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:This position will provide oversight of a team of Global Labeling Strategists responsible for driving labeling strategy and label development as well as managing cross-functional labeling activities to meet Company goals for submission, approval and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products.Responsibilities include, but are not limited to:

• New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical
• Provides leadership and development for direct reports. Oversight of a team of Global Labeling Strategists as part of the New Product Portfolio (NPP) responsible for driving early labeling strategy and label development
• Proactively manages BOW and monitors progress against submission timelines, prioritizes resources to meet Company objectives
• Ensures TPL/ CCDS/labeling documents are prepared and executed in accordance with applicable regulations and company position.
• Is a leader both internally and externally, contributing to cross-functional initiatives and identifies opportunities to influence regulatory policy and climate with respect to labeling content
• Understands and interprets complex scientific issues as related to regulatory requirements and labeling strategy. Partners with key internal and external stakeholders to resolve issues.
• Responsible for ensuring that key stakeholders and line management are informed of key labeling issues/risks with mitigation plans.
• Identifies trends in labeling-related to regulatory authority compliance enforcement, policies and procedures; incorporates into regulatory decisions and strategy
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across enterprise

Degree / Experience Requirements:

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 10 years of Labeling Experience (CCDS / USPI / SmPC) OR Bachelor of Life Sciences with thorough understanding of scientific principles and at least 15 years of Labeling Experience (CCDS / USPI / SmPC)
• Advanced Academic Training (PharmD, PhD, MD) desirable

Skills/Knowledge required:

• Experience in people management and developing and managing a high functioning team including remote team members.
• Knowledge of Global Labeling Guidance/Regulations, 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.
• Proven ability to develop and manage a highly competent and technically skilled team.
• 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.

#LI-HybridIf 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.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 an inclusive culture, promoting diversity 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 a diverse 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 to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Bristol Myers Squibb is Disability Confident – EmployerA UK Government scheme

Expected salary

Location

Uxbridge, Greater London

Job date

Sat, 05 Oct 2024 05:21:56 GMT

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