1+ months

Associate Director, Risk Evaluation and Mitigation Strategy, Operations

Parsippany, NJ 07054
Company Info
Teva is a global pharmaceutical leader and the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and weve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

The Associate Director REMS (Risk Evaluation and Mitigation Strategy) Operations will work closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs.

  • Vendor management.
  • Review and approve program deliverables
  • Monitor and report progress of the program launches and operations, identify risks, highlight issues, seek input/approval from the management
  • Serve as Teva Representative at the Industry Working Groups/Consortiums that collaborate towards shared REMS Programs.
  • Provides internal support for preparing Regulatory documents and acts as Regulatory expert for Teva on REMS related matters, attends REMS program meetings. Interfaces with Regulatory department for REMS document submissions.
  • Proactively search for industry best practices & methods for continuous improvement of and cost-efficient operations.
  • Accountable for the program budgets/financials.
Qualifications

Education Required:  Bachelors degree or equivalent combination of education and related experience. Preferred: Masters Degree in healthcare discipline or MBA

 

Experience Required:  7 + years of direct working experience managing large projects/programs in a regulated industry.  2 + years working with FDA on regulatory submissions.

Experience:

  • Pharmaceutical drug safety/regulatory experience
  • Prior experience of vendor management/oversight
  • Experience with software systems, call center technologies
  • Deeper understanding of FDA regulations on REMS
  • FDA Regulatory knowledge required
Function
Marketing
Sub Function
Market Access
Reports To

Director, REMS Operations

Tevas Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Categories

Posted: 2019-06-05 Expires: 2019-09-18

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director, Risk Evaluation and Mitigation Strategy, Operations

Teva Pharmaceuticals
Parsippany, NJ 07054

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