Director, Regulatory Medical Writing Lead

4 weeks ago


Parsippany, New Jersey, United States Teva Pharmaceutical Industries Full time
About Us

Teva Pharmaceuticals is a global leader in the pharmaceutical industry, dedicated to delivering high-quality medicines to patients worldwide.

Our company is built on a culture of innovation, integrity, and a commitment to making a positive impact on people's lives.

Job Summary

We are seeking a highly experienced and skilled Director, Regulatory Medical Writing to join our Global Regulatory Medical Writing team.

This role will provide leadership and guidance to internal medical writing teams and cross-functional project teams in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug development and product registrations.

Key Responsibilities
  • Provide clear guidance and leadership to internal medical writing teams and cross-functional project teams
  • Oversee the preparation of quality, fit-for-use clinical regulatory documents for various regulatory and reporting purposes
  • Develop and maintain regulatory medical writing processes and standards
  • Collaborate with cross-functional teams to ensure timely and effective document development
  • Ensure compliance with applicable regulatory guidelines, ICH guidance, and Teva standards
Requirements
  • PhD or PharmD in life sciences (or other related field) is preferred or Master's degree in life sciences (or other related field)
  • Minimum 8 years of experience in regulatory medical writing, with a strong background in clinical and regulatory document development
  • Expertise in all document types, with a strong understanding of global regulations and guidelines for document submissions
  • Excellent written and oral communication skills, with the ability to persuade and inspire team members
  • Strong leadership and management skills, with the ability to develop and maintain regulatory medical writing processes and standards
What We Offer

We offer a competitive benefits package, including medical, dental, vision, and prescription coverage, as well as disability and life insurance, paid time off, and a 401(k) matching program.

We are committed to diversity and inclusion, and we welcome applications from qualified candidates from diverse backgrounds.

Apply now to join our team and contribute to the development of innovative medicines that improve patients' lives.



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