Bristol Myers Squibb ASSOCIATE DIRECTOR, LABELING LEAD in Princeton, New Jersey

Summary:

With limited supervision, this position is responsible for co-leading the process of content development and maintenance for the Company Core Data Sheet (CCDS), US Package Insert (USPI), and EU Summary of Product Characteristics (EU-SmPC). This position also supports other local markets in labeling content development and maintenance and in responding to health authority labeling comments.

Key Responsibilities and Major Duties:

  • Follow Corporate policies and directives and department policies and procedures to complete requirements for creation and maintenance of global labeling documents.

  • Provide expertise on label content requirements, standards and processes.

  • Co-lead with the Regulatory Lead a cross-functional labeling team:

  • Plan meetings to discuss and develop label content, including defining agenda, moderating,leading the team through draft text, and taking minutes.

  • Ensure appropriate communications and supportive review materials, including competitive label information, are provided for meeting background and formal approval packages.

  • Assign authors based on expertise, prepare drafts with content from authors and distribute,ensuring timelines and deliverables are met.

  • Ensure alignment/discussion on labeling content takes place with appropriate GRS and non-GRS stakeholders.

  • Ensure authors understand their role in ensuring availability of suitable scientific references for each relevant labeling statement.

  • Coordinate the internal labeling approval process as specified by standard operating procedure.

  • Provide input into regulatory strategy and translate regulatory strategies into project objectives throughout the life-cycle for each product.

  • Create labeling strategy based on understanding of business objectives, data, and regulatory requirements.

  • 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.

  • Contribute to the formulation of labeling procedures and policies that serve the drug development and business goals of the organization.

  • Provide operational and strategic support to local market in responding to HA labeling requests.

  • Fulfill commitments, manage, and prioritize multiple complex projects driving the regulatory process to achieve timely filings and requests additional resources when required.

  • Focus available resources for maximum productivity and impact on product and/or priority initiatives.

  • Work with people and lead diverse and multifunctional, multidisciplinary teams.

  • Participate in health authority discussions as requested by the Global Regulatory Team Lead.

  • Proactively share information with peers and/or subordinate(s) to foster discussion and development.

  • Create and critically assess development plans, effectively communicate strategy and persuade others to accomplish challenging goals and objectives

  • Ensure 100% integrity of labeling.

  • Negotiate balance between safety/efficacy/regulatory/promotional aspects of labeling to address its multiple purposes.

  • Distill and disseminate regulations in a timely and effective manner.

  • Proactively identify and address implications and opportunities of new requirements.

  • Act quickly and decisively in order to meet crucial deadlines without compromising quality or integrity.

  • Strongly support liaison, safety, and other regulatory functions from a labeling perspective.

Qualifications:

  • Advanced degree, PharmD or PhD preferred.

  • 5-8 years regulatory/labeling experience.

  • 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.

  • An in-depth knowledge of BMS policies and procedures and the ability to demonstrate application of BMS’s operating philosophy and operate within company policies

and procedures.

  • Experience with the drug development process and regulatory knowledge and experience.

  • Has a general understanding of pharmacotherapeutics across therapeutic areas.

  • Understanding of operational aspects of labeling projects.

  • Knowledge of BMS and certain external organizations.

  • Thorough understanding of regulatory labeling requirements and industry practice, with primary focus on requirements for CCDS, USPIs, and SmPC.

Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled