Bristol Myers Squibb
Healthcare
SeniorManager,GlobalLabelingStrategy
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“Senior Manager, Global Labeling Strategy at Bristol Myers Squibb. Skills: Global Labeling Strategy, Regulatory Labeling, Product Strategy, Labeling Expertise. Drive labeling strategy. Provide labeling expertise”
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Masters of Life Sciences or equivalent, Bachelor of Lifesciences with 2 years experience, Regulatory or Regulatory Labeling Experience, Understand regulatory implications of product strategy, Develop positive working relationships, Influence and lead diverse Subject Matter Experts, Manage low-to-medium complex projects, Excellent verbal and written communication, Keen attention to detail, Assimilate clinical and scientific information, Present information concisely, Think creatively, Good problem-solving skills
Nice to Have
Basic knowledge of regulatory labeling, Labeling experience in one major region, Basic knowledge of procedures, Good understanding of Drug Development, Good understanding of Commercialization of prescription medicines
What You'll Do.
Drive labeling strategy
Provide labeling expertise
Serve as primary contact
Work closely with counterparts
Serve as interface for Country Regulatory Managers
Support timely and quality labeling submissions
Coordinate labeling activities
Manage label review process
Ensure effective planning
Support responses to inquiries
Review country labels
Participate in key initiatives
Support efficient global label development
Support timely worldwide submissions
How You'll Work.
Team & Collaboration
Global Regulatory Leader; Labeling Strategy Team; Global Regulatory Strategy; Worldwide Patient Safety; Clinical Development; Medical; Country Regulatory Managers; Multifunctional contributors
Communication Scope
Verbal communication; Written communication
Process & Methodology
Lifecycle Management
Full 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. 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](https://careers.bms.com/working-with-us). **Position Summary** The Senior Manager, Global Labeling Strategy, has overall accountability for relevant updates to labeling documents (e.g. Company Core Data Sheets [CCDS], United States Package Inserts [USPI] and EU Summary of Product Characteristics [SmPC]). **Position Responsibilities** \- Drives labeling strategy in partnership with the Global Regulatory Leader (GRL) in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, USPI and SmPC for low to medium complex projects, mainly at a Lifecycle Management (LCM) stage; \- Serves as primary contact for Labeling Strategy Team (LST); \- Works closely with counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST, under management supervision; \- Serves as interface for Country Regulatory Managers to support timely and quality labeling submissions globally; \- Coordinates labeling activities of multifunctional contri
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