• Teva Pharmaceutical
  • Parsippany , NJ
  • Non-Executive Management
  • Full-Time
  • 125 Janelle Blvd

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!

Job Description

Position Summary

The Senior 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.

Qualifications

  • Works closely with Regulatory Affairs, Medical Affairs, Pharmacovigilance and Commercial Operations in the development and management of Risk Management Programs
  • Provides vendor management Participate and/or lead the evaluation & selection of vendors according to Teva s procurement policies where applicable Develop and manage vendor contracts with the support of the supervisor Review and approve vendor invoices 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
  • Attends and serves as Teva Representative at the Industry Working Groups/Consortiums that collaborate towards development and management of shared REMS Programs
  • Provides internal support for preparing Regulatory documents, attends REMS program meetings. Interfaces with Regulatory department for REMS document submissions. Represents Teva for program-specific meetings with FDA
  • Proactively searches for industry best practices and methods for continuous improvement of and cost-efficient operations
  • Manages and tracks program-level budget/financials
  • Education Required: Bachelor s degree or equivalent combination of education and related experience

    Education Preferred: Masters degree in healthcare discipline with a business background OR MBA

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


    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

    Director 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


    Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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