Our Team, Your Impact

The Director, 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.

How You'll Spend Your Day

• Work closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs for a small portfolio of products
• Provide vendor management
• • Evaluate and select vendors according to Teva's procurement policies where applicable
  • Develop and manage vendor contracts
  • 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.
  • Serve as Teva Representative at the Industry Working Groups/Consortiums that collaborate towards shared REMS Programs
• Acts as internal 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 departmental budget/financials

Your Skills and Experience

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

Education Preferred: Master's Degree in healthcare discipline OR MBA

Experience Required: Minimum of 10, preferably 12 years of direct working experience managing large projects/programs in a regulated industry. And Minimum of 5 years working with FDA on regulatory submissions

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

Functional Knowledge: FDA Regulatory knowledge required

Also Good to Have

Job-specific Competencies

1. Analysis / Problem Solving

• Demonstrates ability to analyze and interpret information, reports and data

1. • Demonstrates appropriate judgment and ability to make decisions regarding access to Teva resources

1. 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

1. Leadership and Teamwork
   • Manages projects, sets priorities, meets deadlines, schedules and goals
   • Manages a team of 3

1. Communication
   • Delivers professional presentations and speaks effectively to both external and internal groups, or one on one
   • Understands and follows corporate confidentiality

1. 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

This role offers Hybrid flexibility to our Parsippany, NJ office.

Salary Range

The annual starting salary for this position is between $170,000-$213,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

How We'll Take Care of You

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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