About this opportunity
Teva Pharmaceuticals lists this Director REMS Operations opportunity in parsippany troy hills, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Our Team, Your Impact
Director, REMS Operations responsible for the development and implementation of Risk Management Programs including RiskMAPs and REMS with Elements to Assure Safe Use. The role coordinates with Regulatory Affairs, Sales & Marketing, Medical Affairs, Pharmacovigilance, Legal Affairs, Quality Management & Compliance, and Finance.
How You’ll Spend Your Day
Work closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance to develop and manage Risk Management Programs for a small portfolio of products.
Provide vendor management: evaluate and select vendors, develop and manage vendor contracts, review vendor invoices and program deliverables, monitor progress, identify risks, highlight issues, and seek approval from management.
Serve as Teva Representative at Industry Working Groups/Consortiums collaborating on shared REMS Programs.
Act as internal expert for REMS matters, attend program meetings, and interface with Regulatory department for document submissions.
Proactively search for industry best practices and methods for continuous improvement and cost‑efficient operations.
Accountable for the departmental budget and financials.
Your Skills And Experience
Education Required: Bachelor’s degree or equivalent combination of education and related experience.
Education Preferred: Master’s Degree in a healthcare discipline or MBA.
Experience Required: Minimum of 10 years (preferably 12) of direct working experience managing large projects/programs in a regulated industry and a minimum of 5 years working with FDA on regulatory submissions.
Experience Preferred
Pharmaceutical drug safety and regulatory experience.
Prior experience of vendor management/oversight.
Experience with software systems and call‑center technologies.
Understanding of FDA regulations on REMS.
Functional Knowledge: FDA regulatory knowledge required.
Job‑Specific Competencies
Analysis / Problem Solving – analyze and interpret information, reports and data; make decisions regarding access to resources.
Interpersonal skills – build rapport with stakeholders, collaborate, negotiate, and influence.
Leadership and Teamwork – manage projects, set priorities, meet deadlines, schedule, and lead a team of 3.
Communication – deliver professional presentations and speak effectively to internal and external groups; maintain confidentiality.
Technical Skills – project management, knowledge of FDA regulations and guidance documents, understanding of software development and call‑center technologies, and ability to apply company policies in non‑routine situations.
Location & Flexibility
This role offers hybrid flexibility to our Parsippany, NJ office.
Salary Range
The annual starting salary for this position is $170,000 – $213,000, depending on geography, skills, education, experience, and other qualifications.
How We’ll Take Care Of You
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment when the employee enrolls.
Retirement Savings: 401(k) with employer match up to 6% and an annual 3.75% defined contribution.
Time Off: Paid vacation, sick/safe time, caretaker time, and holidays.
Life and Disability Protection: Company‑paid Life and Disability insurance.
Additional benefits include Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Accounts, Lifestyle Spending Accounts, Volunteer Time Off, Paid Parental Leave (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.
Total compensation may also include restricted stock units and discretionary awards, depending on the position offered.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. Teva’s policy provides equal employment opportunity without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status, or protected veteran status, or any legally recognized status protected under applicable federal, state, or local laws. Requests for accommodations during the recruitment process are treated as confidential; a reasonable accommodation can be requested by email to with the nature of the request and contact information.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.