Takeda Pharmaceuticals
Associate Director, Global Labeling Lead - Remote
Takeda Pharmaceuticals, Bismarck, North Dakota, us, 58502
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout 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 Teams:
Independently 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.Labeling Documents Authoring, Submission, and Labeling Negotiations:
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 with appropriate supervision and guidance.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 with appropriate supervision and guidance.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.Precedent Search and Labeling Trends:
Conducts 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 (TLP, CCDS, USPI, EU SmPC, others as appropriate).Working within Labeling Team and GRA:
Represents Global Labeling at Global Regulatory Team (GRT) and liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.Minimum Requirements/Qualifications:Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience. This is inclusive of 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.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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Independently 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.Labeling Documents Authoring, Submission, and Labeling Negotiations:
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 with appropriate supervision and guidance.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 with appropriate supervision and guidance.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.Precedent Search and Labeling Trends:
Conducts 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 (TLP, CCDS, USPI, EU SmPC, others as appropriate).Working within Labeling Team and GRA:
Represents Global Labeling at Global Regulatory Team (GRT) and liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.Minimum Requirements/Qualifications:Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience. This is inclusive of 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.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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