Global Labeling Lead

Job Description

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. There are two main drivers of innovation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine.

ACCOUNTABILITIES

• Drives labeling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders.
• Strategically interprets scientific, medical, and regulatory data and information.
• Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.
• Provides guidance on combination product/drug-device labeling.
• Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
• Introduces creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities.
• Takes initiative in leading global labeling team and cross-functional projects.
• Leads CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.
• Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy.
• Effectively identifies and resolves conflicts/issues to reach labeling decisions with minimal escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.

DIMENSIONS AND ASPECTS

• Technical/Functional (Line): Expertise in overseeing the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and compliance with regulatory labeling guidance.
• Project Management: Manages and facilitates review of CCDSs and regional labeling, as appropriate, via the Labeling Team and executive governance committees for PDT BU products.
• Compliance: Ensures internal and external stakeholder awareness of proposed and newly approved labeling changes, as required. Ensures compliant version control of product labeling and other related documentation within the Takeda document management systems.
• Leadership: Ability to motivate, mentor and manage diverse cross functional teams, work across functions, regions, and cultures, identify potential challenges and opportunities, and make recommendations.
• Collaboration: Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company, values and promotes differences, recognizes the importance of connections, and brings in key stakeholders to work towards the best possible solutions.
• Communication: Strong communicator, able to persuasively convey ideas verbally and in writing.
• Innovation: Disruptive thinker with the ability to influence and change how R&D uses data to make decisions and set priorities, continuously challenges the status quo and brings forward innovative solutions, identifies areas for process and systems innovation and implements change that will enhance the overall effectiveness of the team.
• Complexity: Delivers solutions to abstract problems across functional areas of the business, identifies and solves fundamental issues for major functional areas through assessment of intangible variables, recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through influencing skills.

Education and Experience Requirements

• Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.). 5-7 years of direct experience in a global, US, or EU labeling role is desired.
• Experience in plasma-derived therapies and biologics preferred.
• Bachelor’s or Master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.
• Previous leadership experience and management of direct reports preferred.
• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance.
• Combination product/drug-device labeling knowledge is preferred.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.