Director, Global Labeling Strategy Lead

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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 for assigned products, including assessment of exceptions and deferrals.

• Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.

Escalation Process and Stakeholder Management

• Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.

• Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content.

• Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions.

Precedent Search and Labeling Trends

• Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.

• Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals.

Working within Labeling Team and GRA

• Represents Global Labeling at Global Regulatory Team (GRT)

• Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.

• Embraces pivotal role in departmental and cross-functional taskforces and initiatives.

• Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.

Vendor Management

• Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.

Continuous Improvement

• Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.

Minimum Requirements/Qualifications:

• BSc degree, preferred; BA accepte.