Associate Director, Global Labeling Lead - Remote

Takeda Pharmaceutical

5+ years

$149,100.00 - $234,300.00

Remote, USA

10 Sept. 17, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job ID: R0128575
Date Posted: 07/16/2024
Location: Remote
Position: Associate Director, Global Labeling Lead

About the Role:
Join Takeda as an Associate Director, Global Labeling Lead and play a crucial role in the development and implementation of labeling strategies for various stages of drug development. You will handle high-complexity products, author and manage labeling documents, and oversee cross-functional collaboration to ensure compliance and alignment with regulatory standards.

Key Responsibilities:

Management of Labeling Teams: Lead and coordinate Labeling cross-functional teams, ensuring alignment and collaboration on labeling strategies and content.
Labeling Documents: Author and manage TLP, CCDS, USPI, and EU SmPC documents, integrating new scientific, safety, and clinical data.
Health Authority Interactions: Drive the process for obtaining labeling approvals from the Global Labeling Oversight Committee (GLOC), and handle label negotiations with health authorities.
Local Exceptions: Manage local labeling alignment and exceptions, supporting Local Affiliates in responding to health authority requests.
Project Management: Employ strong project management skills to coordinate global labeling activities and ensure timely submissions.
Precedent Search and Trends: Analyze competitor and health authority labeling trends to develop competitive labeling strategies.
Vendor Management: Oversee labeling activities managed by external vendors to ensure quality and timely delivery.
Continuous Improvement: Contribute to process improvements and optimize labeling practices for efficiency and accuracy.

Qualifications:

Education: BSc degree required; advanced scientific degree (MSc, PhD, or PharmD) preferred.
Experience: 8+ years in the pharmaceutical industry, including 6 years of labeling experience or a combination of 5+ years in regulatory or related roles.
Knowledge: Strong understanding of US and EU labeling requirements and regulations, scientific principles, and regulatory/quality systems.
Skills: Ability to create and revise product labeling, develop target labeling profiles, and participate in health authority audits.

Compensation and Benefits:

Base Salary: $149,100.00 - $234,300.00, based on qualifications and location.
Incentives: Eligibility for short-term and/or long-term incentives.
Benefits: Includes medical, dental, vision insurance, 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.

Additional Information:
Takeda is committed to creating a diverse workforce and offers equal employment opportunities. For more details on our policies and benefits, please review our Privacy Notice and Terms of Use.

Application:
To apply, click the “Apply” button and ensure all information is accurate.

Locations:
Massachusetts - Virtual
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full-time

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Associate Director, Global Labeling Lead - Remote

Job Description

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