1+ months

Associate Director Risk Evaluation and Mitigation Strategies Operations

Parsippany, NJ 07054
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. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

 

Position Summary

Associate Director Risk Evaluation and Mitigation Strategies 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.

Essential Duties & Responsibilities

  • Work closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs (20%)
  • Provide vendor management (30%)
  • Evaluate and select vendors according to Tevas procurement policies where applicable
  • Develop and manage vendor contractsa and also review and approve vendor invoices
  • Review and approve program deliverables and manages projects, sets priorities, meets deadlines, schedules and goals
  • 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 (10%)
  • 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 (30%)
  • Proactively search for industry best practices & methods for continuous improvement of and cost-efficient operations (5%)
  • Accountable for the program budgets/financials (5%)

Travel Requirements
About 15% of time to mostly domestic locations.

Experience Preferred:


 Pharmaceutical drug safety/regulatory experience
 Prior experience of vendor management/oversight
 Experience with software systems, call center technologies
 Deeper understanding of FDA regulations on Risk Evaluation and Mitigation Strategies Operations

Specialized or Technical Knowledge Licenses, Certifications needed: MS Word, Excel, PowerPoint, MS Project, database skills

  • Functional Knowledge: FDA Regulatory knowledge required
  • Demonstrates ability to analyze and interpret information, reports and data
  • Demonstrates appropriate judgment and ability to make decisions regarding access to Teva resources

Interpersonal

  • Exhibits excellent interpersonal skills and builds rapport when dealing with internal stakeholders, team members/coworkers, management and other external organizations
  • Demonstrates strong collaboration, negotiation, influencing and management skills
  • Leadership and Teamwork
  • Delivers professional presentations and speaks effectively to both external and internal groups, or one on one

Technical Skills

  • Demonstrates project management skills
  • Demonstrates knowledge of FDA regulations, requirements and guidance documents relevant to pharmaceutical product post authorization patient safety / compliance programs
  • Excellent understanding of issues related to software development and call center technologies
  • Ability to use knowledge and understanding of company policies and guidelines to apply in non-routine situations

Education Required:  Bachelors Degree
Education Preferred: Masters Degree in healthcare discipline or MBA

Categories

Posted: 2020-05-02 Expires: 2020-07-29

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 Strategies Operations

Teva Pharmaceuticals
Parsippany, NJ 07054

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