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

7+ years
Not Disclosed
10 Oct. 30, 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

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

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

About the Role:

As an Associate Director, Nonclinical Regulatory Writing and Submission Support focused on Oncology and Marketed Products, you will contribute to our world-class R&D organization that delivers transformative therapies to patients. Join our dynamic team as a vital contributor to our mission.

Key Responsibilities:

  • Provide nonclinical regulatory writing expertise and mentorship.
  • Manage and author nonclinical components of regulatory documents (INDs, NDAs, etc.) for Oncology and other therapeutic areas.
  • Analyze and interpret nonclinical data for submissions, ensuring compliance with ICH guidelines and regulatory requirements.
  • Lead cross-functional teams to define strategies, timelines, and document content for submissions.
  • Develop timelines and manage projects from pre-development through post-marketing stages.

Qualifications:

  • Education: Ph.D. in a scientific field (e.g., pharmacokinetics, toxicology).
  • Experience: 10+ years in nonclinical regulatory writing within a pharmaceutical company or CRO.
  • Significant experience authoring regulatory documents and knowledge of global submission requirements.
  • Strong verbal, written, and interpersonal communication skills.

Why Join Us?

At Takeda, we offer a competitive salary range of $149,100.00 - $234,300.00, along with comprehensive benefits including medical, dental, and vision insurance, a 401(k) plan, paid volunteer time off, and more. We are committed to equitable pay and a diverse workforce.

Apply Today!

If you’re looking for a patient-focused, innovation-driven company, we invite you to apply. Your journey starts here.

EEO Statement:
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants.

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