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Senior Manager, REMS OperationsDate: Jul 15, 2020Location: Parsippany, New Jersey, US, 07054Company: Teva PharmaceuticalsCompany 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.comJob Description 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.Essential Duties & Responsibilities
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
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 and will manage and track program-level budget/financials
Proactively searches for industry best practices and methods for continuous improvement of and cost-efficient operation
Travel RequirementsAbout 15% of time to mostly domestic locationsQualifications Experience Preferred:
Minimum of 5 years of direct working experience in managing or supporting projects/programs in a regulated industry
Pharmaceutical drug safety/regulatory experience and prior experience of vendor management/oversight
Experience with software systems, call center technologies
Understanding of FDA regulations on REMS and FDA Regulatory knowledge
Ability to analyze and interpret information, reports and data
Leadership and Teamwork and and will manages projects, sets priorities, meets deadlines, schedules and goals
Delivers professional presentations and speaks effectively to both external and internal group
Technical Skills
Project Management skills
FDA regulations, requirements and guidance documents relevant to pharmaceutical product post authorization patient safety / compliance programs
Function MarketingSub Function Market AccessReports To In process of validationAlready Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career SiteThe internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.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.EOE including disability/veteran
