Director, Global Labeling Strategy Lead

10+ years

Not Disclosed

Cambridge

10 Dec. 31, 2024

Job Description

Job Type: Full Time Education: MSc./PhD/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description you provided is for a Director, Global Labeling Strategy Lead at Takeda, located in Cambridge, Massachusetts. This role is within the Plasma-Derived Therapies (PDT) R&D Organization, which focuses on developing plasma-derived therapies for immunologic, hematologic, and other complex diseases. Here's a breakdown of the key responsibilities and qualifications for the position:

Key Responsibilities:

Labeling Leadership & Management:
- Lead cross-functional teams to ensure alignment of labeling strategy and content.
- Coordinate the preparation of labeling approval processes with the senior management team, fostering collaboration.
- Provide strategic guidance to the labeling teams to align with Takeda's processes and goals.
- Mentor and manage other labeling leads, ensuring accurate and compliant labeling.
Labeling Documents & Submission:
- Independently author and revise essential documents (TLP, CCDS, USPI, EU SmPC) for assigned products.
- Manage label creation and Health Authority submission processes, ensuring timely delivery and compliance.
- Navigate and negotiate with Health Authorities to ensure appropriate labeling changes.
Stakeholder Management:
- Cultivate relationships with internal teams (clinical, safety, medical affairs) to ensure effective communication for labeling content.
- Provide risk mitigation strategies and escalate issues to senior leadership as needed.
Regulatory & Compliance Expertise:
- Assess and interpret laws, regulations, and guidance related to labeling and ensure adherence to global standards.
- Oversee the alignment of local labeling with global standards and assist with Health Authority inspections.
Vendor Management & Continuous Improvement:
- Manage external vendors handling labeling activities and ensure coordination.
- Contribute to process optimization and continuous improvement of labeling workflows.

Qualifications:

Education: BSc (preferred), MSc/PhD/PharmD (preferred).
Experience:
- 10+ years in the pharmaceutical industry, including at least 8 years in labeling or 6+ years in regulatory affairs or related experience.
- Expertise in US and EU labeling requirements, as well as knowledge of other regional regulatory nuances.
- Proven ability to create and revise product labeling for regulatory submissions.
- Strong project management skills and ability to lead cross-functional teams.

Additional Information:

Location: Cambridge, MA.
Work Type: Full-time, Hybrid (per Takeda’s Hybrid and Remote Work Policy).
Travel: Some travel may be required.
Compensation: Competitive salary with benefits including medical, dental, vision insurance, 401(k) plan, paid time off, and more.

Takeda values diversity and encourages applicants from all backgrounds. The company offers stimulating careers, fosters innovation, and emphasizes collaboration to improve patient health outcomes globally.

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Director, Global Labeling Strategy Lead

Job Description

Key Responsibilities:

Qualifications:

Additional Information:

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