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Sr Director, Global Regulatory Medical Writing & Data Transparency

10-15 years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Remote Education: PhD/Life Science 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

About Us

At Teva Pharmaceuticals, we are driven by a mission to make good health more affordable and accessible, helping millions of people worldwide lead healthier lives. Our global team spans nearly 60 countries and reflects a diverse range of nationalities and backgrounds.

As the world’s leading manufacturer of generic medicines, we proudly produce many products on the World Health Organization’s Essential Medicines List, supporting the health of over 200 million people daily. We are constantly innovating to expand our impact and invite talented individuals to join us in making a difference.


Job Opportunity: Senior Director, Global Regulatory Medical Writing & Data Transparency

We are seeking a Senior Director in Global Regulatory Medical Writing & Data Transparency to lead and manage a team of medical writers, managers, and electronic document specialists. The role ensures the production of high-quality clinical research documentation aligned with regulatory guidelines and departmental standards. This position supports global drug development, product registration, and marketing to meet Teva’s strategic, scientific, and commercial objectives.

  • Location: Hybrid opportunity based in Parsippany, NJ or West Chester, PA.

Key Responsibilities

Leadership & Oversight

  • Provide strategic vision, leadership, and accountability at the global level for clinical regulatory documents.
  • Mentor manager-level direct reports and promote professional development.
  • Serve as a liaison between internal/global functional groups to optimize resource allocation for medical writing support.

Medical Writing Standards

  • Set regulatory medical writing processes, policies, and technical/editorial standards.
  • Ensure clinical research documentation complies with global regulations and guidelines.
  • Act as a subject matter expert in regulatory medical writing, transparency, and disclosure (T&D), as well as clinical drug development.

Collaboration & Process Improvement

  • Oversee the creation of high-quality documentation to support product registrations and marketing initiatives.
  • Collaborate with global teams to address regulatory challenges and optimize documentation strategies.

Your Experience & Qualifications

Required Education & Experience

  • PhD in Life Sciences (or related field) with 10+ years of medical writing experience, OR
  • Master’s degree in Life Sciences (or related field) with 15+ years of medical writing experience.

Skills & Expertise

  • Proven mentor and expert at the global functional level, guiding management-level staff.
  • In-depth knowledge of global regulatory medical writing processes and standards.
  • Advanced understanding of global regulations and guidelines for transparency, disclosure, and document submissions.
  • Exceptional strategic planning and leadership skills.

Teva Benefits

We offer a competitive benefits package, including:

Health & Wellness

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

Financial Benefits

  • 401(k) Retirement Savings: Employer match up to 6%, with an additional 3.75% annual contribution.
  • Employee Stock Purchase Plan.

Time Off

  • Paid Time Off: Vacation, sick/safe time, caretaker leave.
  • 16+ paid holidays, including floating holidays.

Additional Benefits

  • Life and Disability Insurance (company-paid).
  • Family Benefits: Paid parental leave, family-building benefits.
  • Flexible Spending Accounts (FSA), Health Savings Accounts (HSA), Lifestyle Spending Account.
  • Volunteer Time Off and Tuition Assistance.

Already Working @Teva?

Current Teva employees should apply via the Internal Career Site available on "Employee Central" for priority consideration. If you experience access issues, contact your local HR/IT partner.


Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to providing equal employment opportunities without discrimination based on age, race, religion, gender, disability, sexual orientation, veteran status, or any other legally protected characteristic.

We strive for a diverse and inclusive workplace and encourage applicants to request accommodations if needed during the recruitment process. Accommodation requests will remain confidential and used solely to enhance the candidate experience.


Important Notice to Employment Agencies

Teva does not accept unsolicited assistance from agencies for employment opportunities. CVs/resumes submitted by search firms without a valid written agreement will be considered the sole property of Teva, with no fees paid for hires resulting from such submissions.


Join us at Teva to contribute your expertise and leadership to our mission of advancing global healthcare.