Bristol-Myers Squibb Company

ASSOCIATE DIRECTOR, LABELING LEAD

Location
Princeton, NJ, US
Posted
May 12, 2018
Ref
R1503288
Required Education
Doctorate/PHD/MD
Position Type
Full time
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