Associate Director, Global Labeling Lead
Job Level: Senior
Travel: Minimal (if any)
Location: Remote
About Takeda:
Takeda has been advancing science into breakthrough medicines for 240 years. Our R&D environment values diversity of thought and encourages collaboration, enabling the delivery of transformative therapies that make a lasting difference for millions of patients worldwide.
About the Role:
As an Associate Director, Global Labeling Lead, you will be responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development. This includes updates or creation of Target Labeling Profiles (TLP), Company Core Data Sheets (CCDS), United States Prescribing Information (USPI), and European Union Summary of Product Characteristics (EU SmPC), with limited supervision and guidance.
Key Responsibilities:
Management of Labeling Cross-Functional Teams:
Independently lead Labeling Cross-Functional Teams, ensuring collaboration and alignment of labeling strategy and content.
Interface with Senior Management (GLOC):
Coordinate labeling approvals through the Global Labeling Oversight Committee (GLOC).
Prepare and align GLOC Chairs and members through respective functions.
Labeling Document Authoring, Submission, and Negotiations:
Author and revise TLPs, CCDSs, USPIs, and EU SmPCs.
Develop and execute labeling implementation plans.
Manage outgoing communications regarding labeling changes.
Employ project management skills to coordinate end-to-end labeling activities and support label negotiations with Health Authorities.
Management of Local Exceptions and LOC Interactions:
Manage local labeling alignment with CCDS, including assessment of exceptions and deferrals.
Support local affiliates in addressing health authority requests.
Escalation Process and Stakeholder Management:
Escalate issues to Global Labeling Management and Global Regulatory Lead with risk mitigation strategies.
Cultivate strong relationships with cross-functional stakeholders to ensure effective communication.
Precedent Search and Labeling Trends:
Conduct precedent searches and analyze competitor labeling and regulatory trends.
Develop strategic and competitive labeling language.
Representation and Cross-functional Collaboration:
Represent Global Labeling at the Global Regulatory Team (GRT).
Liaise with US and EU Labeling Operations, Device Labeling Lead, and Compliance teams.
Vendor Management:
Oversee labeling activities managed by external vendors ensuring quality and timeliness.
Continuous Improvement:
Actively contribute to the continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.
Minimum Requirements/Qualifications:
Bachelor’s degree (BSc preferred; BA accepted); Advanced degree (MSc, PhD, PharmD) preferred.
8+ years of pharmaceutical industry experience, with 6+ years in labeling or a combination of 5+ years regulatory and/or related experience.
Strong knowledge of US and EU product labeling requirements (USPI and EU SmPC experience required).
Experience in developing and updating product labeling documents (TLP, CCDS, USPI, EU SmPC).
Understanding of global regulatory requirements and Health Authority audit processes.
Strong project management, communication, and stakeholder engagement skills.
Compensation and Benefits:
Base Salary Range: $153,600.00 - $241,340.00 (Massachusetts - Virtual)
Eligible for short-term and long-term incentives.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, tuition reimbursement, paid volunteer time off, company holidays, sick time, and vacation.
EEO Statement:
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or any other characteristic protected by law.
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