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Sr Director, Global Regulatory Medical Writing & Data Transparency

15+ years
Not Disclosed
10 March 26, 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
Location: Parsippany, NJ, United States
Company: Teva Pharmaceuticals

About the Company:

Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines and a key producer of essential medications on the WHO’s Essential Medicines List. With operations in nearly 60 countries, Teva impacts 200 million people worldwide daily.

Role Overview:

The Senior Director, Global Regulatory Medical Writing & Data Transparency provides leadership and direction to a team of medical writers and document specialists, ensuring high-quality clinical documentation that supports global regulatory submissions.

Key Responsibilities:

  • Strategic Leadership: Provide strategic vision and accountability for clinical regulatory documentation and ensure global standards are met.

  • Team Management: Mentor and guide manager-level direct reports and ensure optimal resource utilization.

  • Process Development: Establish processes and policies for regulatory medical writing and data transparency.

  • Collaboration: Act as a liaison across global functional groups to align goals and objectives.

  • Expert Consultation: Serve as a subject matter expert on all aspects of regulatory medical writing and clinical drug development.

Qualifications:

  • Education:

    • PhD in Life Sciences (or related field) with 10+ years of relevant experience

    • OR Master's in Life Sciences (or related field) with 15+ years of experience

  • Experience:

    • Proven expertise in regulatory medical writing and clinical drug development

    • Strong knowledge of global regulations and document submission standards

    • Experienced mentor and leader at a global function level

Skills:

  • Strong analytical and decision-making skills

  • Excellent communication and interpersonal skills

  • Proficient in regulatory documentation processes and technical standards

Location & Work Arrangement:

  • Location: Parsippany, NJ or West Chester, PA

  • Work Model: Hybrid

Benefits Package:

  • Health Insurance: Medical, Dental, Vision, and Prescription coverage from day one.

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

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

  • Life & Disability: Company-paid Life and Disability insurance.

  • Additional Benefits: Tuition assistance, Flexible Spending Accounts, Employee Stock Purchase Plan, Paid Parental Leave, and more.

Equal Employment Opportunity:

Teva Pharmaceuticals is committed to a diverse and inclusive workplace, providing equal employment opportunities regardless of age, race, religion, sex, disability, sexual orientation, or other legally protected status.

Application Process:

Current Teva employees should apply via the internal career site on "Employee Central."
Note: Teva does not accept unsolicited CVs from agencies without a valid written agreement.