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Sr Director, Global Regulatory Medical Writing & Data Transparency

10+ years
Not Disclosed
10 March 21, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Sr Director, Global Regulatory Medical Writing & Data Transparency - 59073

Company: Teva Pharmaceuticals
Location: Parsippany, NJ / West Chester, PA (Hybrid)
Date: February 24, 2025

Who We Are:
Teva Pharmaceuticals is dedicated to making healthcare affordable and accessible across 60 countries, helping millions lead healthier lives. As the world’s leading manufacturer of generic medicines, Teva produces many products listed on the World Health Organization's Essential Medicines List, impacting at least 200 million people daily.

The Opportunity:
The Senior Director, Global Regulatory Medical Writing & Data Transparency, leads a team of medical writers, managers, and electronic document specialists within Clinical Specialty Development. The role ensures the production of high-quality clinical research documentation aligned with regulatory guidelines, supporting drug development, product registrations, and marketing to meet Teva’s global scientific, regulatory, and commercial goals.

Responsibilities:

  • Provide leadership, direction, and accountability for clinical regulatory documents at a global function level.

  • Serve as a liaison between internal/global functional groups to optimize resource use and medical writing support across projects.

  • Mentor and guide manager-level direct reports.

  • Establish regulatory medical writing processes, policies, and editorial standards.

Your Experience and Qualifications:

  • Education:

    • PhD in Life Sciences (or related field) with at least 10 years of experience

    • OR Master’s in Life Sciences (or related field) with at least 15 years of experience

  • Expertise:

    • Extensive experience in regulatory medical writing and clinical drug development

    • Advanced knowledge of global regulations and guidelines for transparency and disclosure (T&D) and document submissions

    • Proficiency in setting processes, policies, and technical standards

    • Recognized as an internal expert and mentor at the global functional level

Compensation and Benefits:

  • Health Insurance: Comprehensive medical, dental, vision, and prescription coverage starting on the first day of employment.

  • Retirement Savings: 401(k) with employer match (up to 6%) and an annual 3.75% defined contribution.

  • Paid Time Off: Vacation, sick/safe time, caretaker time, 13 paid holidays, and 3 floating holidays.

  • Life and Disability Insurance: Company-paid life and disability coverage.

  • Additional Benefits:

    • Employee Assistance Program

    • Employee Stock Purchase Plan

    • Tuition Assistance

    • Flexible Spending Accounts

    • Health Savings Account

    • Lifestyle Spending Account

    • Paid Parental Leave (if eligible)

    • Family Building Benefits

    • Identity Theft Protection

    • Legal Plan, and more

Application Guidelines:
If you are a current Teva employee, please apply using the internal career site via "Employee Central" for priority consideration.

Equal Employment Opportunity:
Teva Pharmaceuticals provides equal employment opportunities without regard to age, race, creed, religion, sex, disability, medical condition, sexual orientation, gender identity, national origin, or any other legally protected status.

Important Notice to Employment Agencies:
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies. All CVs/resumes submitted by search firms without a valid written agreement in place will be considered the sole property of Teva.