Associate Director, Global Labeling Lead
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Associate Director, Global Labeling Lead at Takeda. Responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development, including updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. Responsibilities
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): coordinates the process to obtain labeling approval by the Global Labeling Oversight Committee and drives cross-functional collaboration and alignment of labeling strategy and content at all levels; ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. 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 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, enabling up-to-date information for patients and Health Care Providers while complying with labeling requirements and minimizing write-offs; independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes with supervision. Employs strong project management to coordinate global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submission; plays a key role in label negotiations with Health Authorities (leading or with GRL). Interprets laws, regulations, and guidance documents relevant to labeling documentation and ensures Takeda labeling content and processes conform to regulatory requirements. Manages alignment of local labeling with CCDS for assigned products, including assessment of exceptions/deferrals; provides support to Local Affiliates for responses to health authorities and alignment deferrals. Escalates issues to Global Labeling management and GRL and proposes risk mitigation strategies; cultivates relationships across clinical, safety, medical affairs, and commercial functions to ensure effective labeling communication. Performs precedent searches and analyzes competitor labeling, health authority requests, labeling guidance and trends; develops strategies and labeling language for TLP, CCDS, USPI, EU SmPC to align with product strategy; represents Global Labeling at GRT; liaises with US/EU labeling operations and other labeling teams to meet objectives and timelines; supports Health Authority inspections with labeling information requests. Oversees labeling activities managed by external vendors for assigned products, ensuring coordination, timely delivery, and quality. Contributes to continuous improvement of labeling processes, identifying opportunities to enhance agility, efficiency, and accuracy. Qualifications
Required: BSc degree (BA accepted). Preferred: Advanced scientific degree (MSc, PhD, or PharmD). Required: 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience. Required: Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). Required: Knowledge of US and/or EU regulatory requirements and guidelines; knowledge of other relevant regional regulatory nuances. Required: Knowledge of scientific principles and regulatory/quality systems relevant to drug development. Required: Ability to create, revise and/or update product labeling (CCDS, USPI and EU SmPC) for regulatory submissions with minimal supervision; ability to develop target labeling profile (TLP) with minimal supervision. Required: Understanding of global labeling concepts and implications across the organization; knowledge of Health Authority audit processes and ability to participate in audits/inspections. Skills
Cross-functional collaboration and stakeholder management Regulatory labeling strategy and document authoring Project management and global coordination Regulatory compliance and audit readiness Health Authority negotiations and written communications Education
Bachelor’s degree required; advanced scientific degree preferred (MSc, PhD, or PharmD).
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Associate Director, Global Labeling Lead at Takeda. Responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development, including updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. Responsibilities
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): coordinates the process to obtain labeling approval by the Global Labeling Oversight Committee and drives cross-functional collaboration and alignment of labeling strategy and content at all levels; ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. 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 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, enabling up-to-date information for patients and Health Care Providers while complying with labeling requirements and minimizing write-offs; independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes with supervision. Employs strong project management to coordinate global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submission; plays a key role in label negotiations with Health Authorities (leading or with GRL). Interprets laws, regulations, and guidance documents relevant to labeling documentation and ensures Takeda labeling content and processes conform to regulatory requirements. Manages alignment of local labeling with CCDS for assigned products, including assessment of exceptions/deferrals; provides support to Local Affiliates for responses to health authorities and alignment deferrals. Escalates issues to Global Labeling management and GRL and proposes risk mitigation strategies; cultivates relationships across clinical, safety, medical affairs, and commercial functions to ensure effective labeling communication. Performs precedent searches and analyzes competitor labeling, health authority requests, labeling guidance and trends; develops strategies and labeling language for TLP, CCDS, USPI, EU SmPC to align with product strategy; represents Global Labeling at GRT; liaises with US/EU labeling operations and other labeling teams to meet objectives and timelines; supports Health Authority inspections with labeling information requests. Oversees labeling activities managed by external vendors for assigned products, ensuring coordination, timely delivery, and quality. Contributes to continuous improvement of labeling processes, identifying opportunities to enhance agility, efficiency, and accuracy. Qualifications
Required: BSc degree (BA accepted). Preferred: Advanced scientific degree (MSc, PhD, or PharmD). Required: 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience. Required: Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). Required: Knowledge of US and/or EU regulatory requirements and guidelines; knowledge of other relevant regional regulatory nuances. Required: Knowledge of scientific principles and regulatory/quality systems relevant to drug development. Required: Ability to create, revise and/or update product labeling (CCDS, USPI and EU SmPC) for regulatory submissions with minimal supervision; ability to develop target labeling profile (TLP) with minimal supervision. Required: Understanding of global labeling concepts and implications across the organization; knowledge of Health Authority audit processes and ability to participate in audits/inspections. Skills
Cross-functional collaboration and stakeholder management Regulatory labeling strategy and document authoring Project management and global coordination Regulatory compliance and audit readiness Health Authority negotiations and written communications Education
Bachelor’s degree required; advanced scientific degree preferred (MSc, PhD, or PharmD).
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