Takeda Pharmaceutical (US)
Associate Director, Global Labeling Lead - Remote
Takeda Pharmaceutical (US), Boston, Massachusetts, us, 02298
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Job Description
About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance.
How you will contribute:
Management of Labeling Cross-Functional TeamsIndependently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content.
Interface with Senior Management Cross-Functional Team (GLOC)In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and 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.
Labeling Documents Authoring, Submission, and Labeling NegotiationsAuthors 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 with appropriate supervision and guidance.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.Independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance.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.Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation.
Management of Local Exceptions and LOC InteractionsManages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance.Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.
Escalation Process and Stakeholder ManagementAppropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products.Strategically develop and cultivate strong relationships among functions represented at the Labeling cross-functional teams.
Precedent Search and Labeling TrendsConducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels.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.Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
Vendor ManagementOversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
Continuous ImprovementActively 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 accepted.Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience, including 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).Knowledge of US and/or EU regulatory requirements and guidelines.Knowledge of other relevant regional regulatory nuances and requirements.Knowledge of scientific principles and regulatory/quality systems relevant to drug development.Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance.Ability to develop target labeling profile (TLP) with minimal supervision and guidance.Understanding of the broad concepts within global labeling and implications across the organization and globally.Knowledge of Health Authority audit process and ability to participate in partner/health authority audits and inspections.
More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.#J-18808-Ljbffr
Job Description
About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance.
How you will contribute:
Management of Labeling Cross-Functional TeamsIndependently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content.
Interface with Senior Management Cross-Functional Team (GLOC)In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and 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.
Labeling Documents Authoring, Submission, and Labeling NegotiationsAuthors 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 with appropriate supervision and guidance.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.Independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance.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.Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation.
Management of Local Exceptions and LOC InteractionsManages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance.Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.
Escalation Process and Stakeholder ManagementAppropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products.Strategically develop and cultivate strong relationships among functions represented at the Labeling cross-functional teams.
Precedent Search and Labeling TrendsConducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels.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.Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
Vendor ManagementOversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
Continuous ImprovementActively 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 accepted.Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience, including 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).Knowledge of US and/or EU regulatory requirements and guidelines.Knowledge of other relevant regional regulatory nuances and requirements.Knowledge of scientific principles and regulatory/quality systems relevant to drug development.Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance.Ability to develop target labeling profile (TLP) with minimal supervision and guidance.Understanding of the broad concepts within global labeling and implications across the organization and globally.Knowledge of Health Authority audit process and ability to participate in partner/health authority audits and inspections.
More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.#J-18808-Ljbffr