Bristol-Myers Squibb Company

DIRECTOR, GLOBAL LABELING

Location
Lawrence Township, NJ, US
Posted
Oct 07, 2018
Ref
R1503109
Required Education
Doctorate/PHD/MD
Position Type
Full time
DIRECTOR, GLOBAL LABELING

Partner with the Global Regulatory Team Lead (GRTL) to drive the development and management of the cross-functional labeling activities (USPI/ SmPC/ Company Core Data Sheet/ ROW labeling) to meet time and quality performance goals for filing and approval of global labels as planned by the Full Development Team.

Strategy

1. Co-leads (with GRTL) the development and management of cross-functional labeling strategy in support of the full development strategy to achieve target labeling objectives and timely approvals

2. Coordinates and drives development of multiple concurrent labeling changes for complex, multi-indication assets in accelerated development

3. Ensures labeling strategy is integrated to support filings and approvals in the intended key markets

4. Identifies opportunities to influence regulatory policy and climate with respect to labeling content and preparation in support of project goals and BMS preferences

5. Applies knowledge of internal and external guidances, as well as project historical norms, in providing feedback to the cross-functional labeling team on issues related to labeling.

Execution

1. Ensures effective planning of all cross-functional labeling activities required to produce high quality and consistent labels for submission to health authorities

2. Coordinates labeling activities of multi-functional contributors, reviewers, and approvers from discovery, pharmaceutical development, clinical discovery and clinical development, regulatory, pharmacovigliance, commercial, and legal; and manages the label review and approval process to maximize speed and quality on behalf of the FDT

3. Contributes to the development of effective labeling processes and standards; implements the processes to support FDT goals and ensures maintenance of PRI labeling/regulatory standards

4. Partners with GRTL to support the cross-functional labeling team members in the development and management of key labeling messages and issues, taking into account historical project content and competitor labels, and ensures appropriate integration into the label in a consistent way

5. Drives the cross-functional labeling preparation and product life-cycle processes to ensure

6. Influences the FDT in tracking milestone activities and proactively identifies any issue

7. In conjunction with the team members, manages and prepares updates to proposed labeling in response to dossier-related health authority questions

Team Leadership

1. Leads and influences a diverse group of subject matter experts/authors of labeling documents from a variety of disciplines without a reporting relationship

2. Mentors and trains members of cross-functional labeling team in principles and processes

3. Oversees the work of multiple labeling leads across multiple cross-functional labeling teams for complex, multi-indication assets in accelerated development

4. Proactively manages progress against the submission timelines, identifies opportunities, and drives potential solutions with key team members

5. As a leader within regulatory documentation strategy team, proactively shares knowledge and key learnings within and across development teams

Qualifications

Knowledge Desired

• MD/PhD or equivalent, with thorough understanding of scientific principles and hypothesis testing and at least 5 years of pharmaceutical regulatory labeling experience

• Demonstrated strong writing skills as evidenced by good quality writing in publications in peer-reviewed journals or in regulatory documentation

• Analyzed and interpreted complex data from a broad range of scientific disciplines

Experiences Desired

• At least 10 years of experience in preparing USPIs, SmPCs, and Company Core Data Sheets

• Career experience driving a wide variety of labeling activities for at least 5 assets and in multiple therapeutic areas

• Good understanding of US and European labeling requirements for submission of USPIs and SmPCs to health authorities

• Worked successfully in a cross-functional project team; ability to lead/facilitate discussions and decision-making with cross-functional team members

• Assessed the requirements and provided tools, information and/or training to external documentation resources in order to produce document(s) that meet sponsor's labeling documentation standards

Desired Outcomes

• Submission of labeling documentation in timely fashion without undue stress to the organization

• All key team members are clear on timelines and expectations of labeling development, preparation, and submission

• Successful negotiation with health authorities on the proposed labeling

• Knowledge Management - knowledge gained from one therapeutic area and/or product is applied across others, e.g. requirements, processes, etc.