Associate Director, Global Labeling, Established Brands

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 . Key Responsibilities Develops and communicates the strategic direction for the team in alignment with the Executive Director, Global Labeling Set clear performance standards, provides feedback and coaching, identifies and fulfills training needs, and holds the group members accountable for key deliverables. Manages performance together with relevant cross-functional project team leaders. Oversees the BoW for Labeling and ensures that all deliverables are met with high quality and in line with project timelines Maintains up-to-date knowledge of extensive and complex worldwide regulatory labeling requirements, assessing and communicating impact on BMS business and products (working with BMS policy group as appropriate); Lead labeling strategy in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, competitor analyses) for CCDS, USPI and EU SmPC as applicable. Revise 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 appropriate supervision and guidance. Employ strong project management skills to coordinate global labeling 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). Drive the development and implementation of CCDS, USPI, and EU SmPC. Work closely with TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST with management support to ensure seamless labeling strategy execution Coordinate labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality. Support Country Regulatory Managers in timely labeling submissions, implementations globally. Review country labels to ensure labeling compliance and assess labeling differences to CCDS. Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities. Provide operational guidance and oversight to ensure all labeling documents are accurate, consistent, and compliant with all current regional regulatory regulation, guidance, templates, and requirements. Identify opportunities for process improvements, new tools and technology adoption to enhance global labeling development 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 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. Show more Show less