Takeda Pharmaceuticals
Associate Director, Global Labeling Lead - Remote
Takeda Pharmaceuticals, Juneau, Alaska, us, 99812
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:With guidance from leadership:Management of Labeling Cross-Functional Teams:
Independently leads Labeling cross-functional teams driving collaboration and alignment of the labeling strategy and content.Interface with Senior Management Cross-Functional Team (GLOC):
Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC).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.Management of Local Exceptions and LOC Interactions:
Manages process for alignment of local labeling with CCDS for assigned products.Escalation Process and Stakeholder Management:
Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL).Precedent Search and Labeling Trends:
Conducts precedent, analyzes relevant competitor labeling, and develops strategies for assigned product labels.Working within Labeling Team and GRA:
Represents Global Labeling at Global Regulatory Team (GRT) and liaises with various operations to ensure objectives and timelines are met.Minimum Requirements/Qualifications:Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience, including 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience.Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.Ability to create, revise and/or update product labeling for regulatory submissions with minimal supervision.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.
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Independently leads Labeling cross-functional teams driving collaboration and alignment of the labeling strategy and content.Interface with Senior Management Cross-Functional Team (GLOC):
Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC).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.Management of Local Exceptions and LOC Interactions:
Manages process for alignment of local labeling with CCDS for assigned products.Escalation Process and Stakeholder Management:
Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL).Precedent Search and Labeling Trends:
Conducts precedent, analyzes relevant competitor labeling, and develops strategies for assigned product labels.Working within Labeling Team and GRA:
Represents Global Labeling at Global Regulatory Team (GRT) and liaises with various operations to ensure objectives and timelines are met.Minimum Requirements/Qualifications:Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience, including 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience.Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.Ability to create, revise and/or update product labeling for regulatory submissions with minimal supervision.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.
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