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Job Description

About the role:

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director, Global Labeling Strategy Lead is a key role in the PDT R&D organization accountable for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.

How you will contribute:

Management of Labeling Cross-Functional Teams

• Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content.

Interface with Senior Management Cross-Functional Team (GLOC)

• In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.

• Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.

Strategic Leadership

• Provide high level strategic guidance and leadership to the labeling leads, ensuring that the strategies align with Takeda processes (eg. Future Fit and Submission Excellence).

• Acts as the liaison between the labeling team members and senior leadership advocating for labeling strategies.

• Elevate the visibility and value of the labeling function within the organization and cross-functional teams, including GPT, SWGs, etc.

• Mentor other labeling leads and/or review the labeling implementation plans to ensure the most up-to-date, compliant information is provided to patients and Health Care Providers while the risk of write- offs is minimized.

Labeling Documents Authoring, Submission, and Labeling Negotiations

• Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation.

• In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs.

• Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products.

• Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL).

• Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements.

Management of Local Exceptions and LOC Interactions

• Manages process for alignment of local labeling with CCDS f