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