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Manager, REMS Operations - Parippany NJ

Date: May 8, 2019

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s 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 world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve 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!

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

Job Description

Position Summary

The Manager, REMS Operations is responsible for the development and implementation of Risk Management Programs including RiskMAPs, REMS with Elements to Assure Safe Use. This individual works in coordination with Regulatory Affairs for timely approvals and communications with regulatory agencies, Sales & Marketing for on-time launches and ensuring stakeholder enrollment in the programs, Legal Affairs for reviewing the vendor contracts and industry agreements, Pharmacovigilance for safety monitoring & reporting, Medical Affairs for the development and review of educational materials, Quality Management & Compliance for audits, and Finance for program budgets.

 

Travel Requirements

About 15% of time to mostly domestic locations.

 

Essential Duties & Responsibilities

 

  1. Works closely with Regulatory Affairs, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs (20%)
  2. Provides vendor management (40%)
    1. Participate and/or lead the evaluation & selection of vendors according to Teva’s procurement policies where applicable
    2. Develop and manage vendor contracts with the support of the supervisor
    3. Review and approve vendor invoices
    4. Review and approve program deliverables
    5. Monitor and report progress of the program launches and operations, identify risks, highlight issues, seek input/approval from the management
  3. Attends and may serve as Teva Representative at the Industry Working Groups/Consortiums that collaborate towards shared REMS Programs (15%)
  4. Provides internal support for preparing Regulatory documents, attends REMS program meetings. Interfaces with Regulatory department for REMS document submissions (20%)
  5. Supports the director in preparing program budgets/financials (5%)

Qualifications

Education Required:  Bachelor’s degree or equivalent combination of education and related experience

Experience Required:  Minimum of 3, preferably 5 years of direct working experience in managing or supporting projects/programs in a regulated industry

Experience Preferred:

  • Pharmaceutical drug safety/regulatory experience
  • Prior experience of vendor management/oversight
  • Experience with software systems, call center technologies
  • Understanding of FDA regulations on REMS
     
    Specialized or Technical Knowledge Licenses, Certifications needed:
  • MS Word, Excel, PowerPoint, MS Project, database skills
     
    Functional Knowledge: FDA Regulatory knowledge preferred

Function

Marketing

Sub Function

Market Access

Reports To

Dir REMS Operations

Teva’s 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.


Nearest Major Market: New York City
Nearest Secondary Market: Newark

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