Bristol-Myers Squibb Company

ASSOCIATE DIRECTOR, LABELING LEAD

Location
Plainsboro, NJ, US
Posted
May 12, 2018
Ref
R1502424
Required Education
Doctorate/PHD/MD
Position Type
Full time
About Bristol-Myers Squibb: 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. And 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.

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.