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    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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