Senior Director, Global Labeling Strategy Team Lead
| Posting date: | 14 May 2024 |
|---|---|
| Hours: | Full time |
| Closing date: | 13 June 2024 |
| Location: | Uxbridge, London |
| Remote working: | Hybrid - work remotely up to 2 days per week |
| Company: | Bristol-Myers Squibb |
| Job type: | Permanent |
| Job reference: | R1580462 |
Summary
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.
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.