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 .
Key Responsibilities
- Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy for assigned products.
- Provides labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, USPI and SmPC (Centralized/Mutual Recognition/Decentralized Procedure) for Established Brands.
- Leads the Labeling Strategy Team (LST).
- Works closely with counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), and Medical.
- Serves as interface for Country Regulatory Managers to support timely and quality labeling submissions globally.
- Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.
- Ensures effective planning of all cross-functional labeling activities.
- Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.
- Reviews country labels to ensure labeling compliance.
- Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.
Requirements:
- Basic knowledge of regulatory labeling and labeling processes
- Labeling expertise in at least one major region and CCDS.
- Basic knowledge of procedures, regulatory requirements and GxP.
- Good understanding of Drug Development and Commercialization of prescription medicines
- Ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.
- 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.
- Experience in managing medium complex projects.
- Proficient time and project management skills
- Excellent verbal and written communication skills with the ability to collaborate effectively in a global, cross-functional environment.
- 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.
Educational Qualifications:
- Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Life Sciences with at least 2 years of Regulatory and /or regulatory Labeling Experience.
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.
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
Responsibilities
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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
