Director REMS Operations

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration.

About the role

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.

Responsibilities

• 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
• Act as internal expert for Teva on REMS related matters, attend REMS program meetings, interface 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

Requirements

• Bachelor’s degree or equivalent combination of education and related experience
• Minimum of 10, preferably 12 years of direct working experience managing large projects/programs in a regulated industry
• Minimum of 5 years working with FDA on regulatory submissions
• Pharmaceutical drug safety/regulatory experience
• Prior experience of vendor management/oversight
• Experience with software systems, call center technologies
• Understanding of FDA regulations on REMS

Qualifications

• Master’s Degree in healthcare discipline OR MBA (preferred)
• FDA Regulatory knowledge required
• Demonstrates ability to analyze and interpret information, reports and data
• 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
• Manages projects, sets priorities, meets deadlines, schedules and goals
• Manages a team of 3
• Delivers professional presentations and speaks effectively to both external and internal groups, or one on one
• Understands and follows corporate confidentiality
• 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

Pay

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.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan
• Paid Time Off including vacation, sick/safe time, caretaker time and holidays
• Company paid Life and Disability insurance
• 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

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered.

Schedule

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