MANAGER, GLOBAL LABELING OPERATIONS, LAB(Job Number: 1203622)
- Lead the process of content development for the Company Core Data Sheet (CCDS), US Package Insert (USPI), and EU Summary of Product Characteristics (EU-SmPC) and provide operational support for all labels worldwide for molecular entities under development and for revisions to these documents for marketed products.
- Manage several aspects of the planning and development of product labels to support the timely and accurate registration of new products and the maintenance of marketed products.
- Participate on global and regional regulatory and project development teams to identify, evaluate, and provide operational guidance on labeling issues for new chemical entities, lifecycle management projects and mature brands.
- Formulate labeling procedures and policies that serve the drug development and business goals of the organization.
- Provide expertise on label content requirements, standards and processes.
- Manage and prioritize multiple complex projects driving the regulatory process to achieve timely filings.
- Work with people and lead diverse and multifunctional, multidisciplinary teams.
- Follow Corporate policies and directives and department policies to complete requirements for creation and maintenance of global labeling documents.
Job Function: Regulatory
- Demonstrated ability to work with and manage people and teams in a complex and culturally diverse, global, dynamic environment to deliver value-added results to the organization.
- Demonstrated ability to apply BMS's operating philosophy and operate within company policies and procedures.
- Advanced degree, PharmD or PhD preferred. Previous industry experience preferred.
- Experience with the drug development process and regulatory knowledge and experience.
- Has a general understanding of relevant regulations. Ability to distill and disseminate regulations in a timely and effective manner.
- Understanding of regulatory agencies, industry practice, and the drug development process.
Primary Location: NA-US-NJ-Plainsboro
: R&D - Global Regulatory Sciences & Pharmacovigilance (GRS&P)
Bristol-Myers Squibb - 21 months ago
Bristol-Myers Squibb (BMS) may be a giant in transition, but its still a pharmaceutical giant. The company's blockbuster cardiovascular...