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    Associate Director, Nonclinical Regulatory Writing And Submission Support, Oncology And Marketed Products

    Takeda Pharmaceutical
    10+ years
    $149,100.00 - $234,300.00
    Remote
    10 Oct. 29, 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 Opportunity: Associate Director, Nonclinical Regulatory Writing and Submission Support, Oncology and Marketed Products at Takeda

    Job ID: R0134567
    Date Posted: 09/18/2024
    Location: Remote

    At Takeda, we strive to provide transformational opportunities for every member of our team, empowering our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive—at work and beyond.

    About the Role

    As an Associate Director in Nonclinical Regulatory Writing and Submission Support, you will play a vital role in our R&D organization, focusing on oncology and marketed products. Reporting to the Nonclinical Regulatory Writing and Submission Support team lead, you’ll contribute to a dynamic environment with projects that span Takeda’s diverse therapeutic areas, including Oncology, Gastrointestinal, Inflammation, and Neuroscience.

    Key Responsibilities

    • Provide expertise and mentorship in nonclinical regulatory writing to NRWS and R&D staff.
    • Manage diverse projects across all developmental stages, with a focus on oncology programs and marketed products.
    • Develop writing strategies and compose regulatory documents, ensuring compliance with ICH guidelines and regulatory requirements.
    • Lead nonclinical submission working groups, coordinating with cross-functional teams to align on strategy and timelines.
    • Author and edit nonclinical documents for submissions, including INDs, NDAs, BLAs, and more.
    • Serve as a representative on cross-functional initiatives, applying principles of regulatory writing and lean authoring.

    Minimum Requirements

    • Education: Ph.D. in a scientific field (e.g., pharmacokinetics, pharmacology, toxicology).
    • Experience: Minimum of 10 years of leadership experience in nonclinical regulatory writing within a pharmaceutical company or CRO.
    • Direct involvement in the drug development process, with significant experience authoring nonclinical summary sections for regulatory submissions.
    • Strong understanding of regulatory guidelines (FDA/EMA/ICH) and compliance requirements.
    • Excellent verbal, written, and interpersonal communication skills.

    Additional Information

    • This position is remote, with occasional face-to-face meetings, likely in Boston, MA.
    • Most project meetings are scheduled based on Eastern Time standard working hours (8 AM – 5 PM ET).

    Compensation and Benefits

    U.S. Base Salary Range: $149,100.00 - $234,300.00
    Compensation will depend on factors such as qualifications, experience, and location. U.S.-based employees may also be eligible for various benefits, including medical, dental, vision insurance, 401(k) matching, tuition reimbursement, paid vacation, and sick time.

    EEO Statement

    Takeda is committed to creating a diverse workforce and providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or other protected characteristics.

    If you are ready to engage in meaningful work with a patient-focused, innovation-driven company, apply today!

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