| Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives. Partner with the Global Regulatory Team Lead (GRTL) to drive the development and management of the cross-functional labeling activities (USPI/ SmPC/ Company Core Data Sheet/ ROW labeling) to meet time and quality performance goals for filing and approval of global labels as planned by the Full Development Team. Strategy Co-leads (with GRTL) the development and management of cross-functional labeling strategy in support of the full development strategy to achieve target labeling objectives and timely approvals Coordinates and drives development of multiple concurrent labeling changes for complex, multi-indication assets in accelerated development Ensures labeling strategy is integrated to support filings and approvals in the intended key markets Identifies opportunities to influence regulatory policy and climate with respect to labeling content and preparation in support of project goals and BMS preferences Applies knowledge of internal and external guidances, as well as project historical norms, in providing feedback to the cross-functional labeling team on issues related to labeling. Execution Ensures effective planning of all cross-functional labeling activities required to produce high quality and consistent labels for submission to health authorities Coordinates labeling activities of multi-functional contributors, reviewers, and approvers from discovery, pharmaceutical development, clinical discovery and clinical development, regulatory, pharmacovigliance, commercial, and legal; and manages the label review and approval process to maximize speed and quality on behalf of the FDT Contributes to the development of effective labeling processes and standards; implements the processes to support FDT goals and ensures maintenance of PRI labeling/regulatory standards Partners with GRTL to support the cross-functional labeling team members in the development and management of key labeling messages and issues, taking into account historical project content and competitor labels, and ensures appropriate integration into the label in a consistent way Drives the cross-functional labeling preparation and product life-cycle processes to ensure Influences the FDT in tracking milestone activities and proactively identifies any issue In conjunction with the team members, manages and prepares updates to proposed labeling in response to dossier-related health authority questions Team Leadership Leads and influences a diverse group of subject matter experts/authors of labeling documents from a variety of disciplines without a reporting relationship Mentors and trains members of cross-functional labeling team in principles and processes Oversees the work of multiple labeling leads across multiple cross-functional labeling teams for complex, multi-indication assets in accelerated development Proactively manages progress against the submission timelines, identifies opportunities, and drives potential solutions with key team members As a leader within regulatory documentation strategy team, proactively shares knowledge and key learnings within and across development teams | 
