Associate Director, REMS Operations
Teva Pharmaceuticals
July 02, 2026
Remote friendly (Parsippany, NJ)
United States
Operations
Associate Director, REMS Operations
Travel Requirements
- About 15% domestic travel.
Essential Duties & Responsibilities
- Develop and manage Risk Management Programs (RiskMAPs, REMS with Elements to Assure Safe Use) with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance (20%).
- Vendor management (20%): evaluate/select vendors (per procurement policies), develop/manage vendor contracts, review/approve vendor invoices and program deliverables, monitor/report launch & operations progress, identify risks/issues, and seek management input/approval.
- Serve as Teva representative at industry working groups/consortiums collaborating on shared REMS programs (10%).
- Provide internal support for Regulatory documents; act as Regulatory expert on REMS matters; attend REMS program meetings; interface with Regulatory for REMS submissions (30%).
- Identify industry best practices for continuous improvement and cost-efficient operations (5%).
- Accountable for program budgets/financials (5%).
- Manage/coaching/mentoring one or more associates (10%).
Qualifications / Skills & Experience
- Education: Bachelor’s degree or equivalent combination of education and related experience; Preferred: Master’s degree in healthcare discipline or MBA.
- Experience: 7+ years (preferably 10) managing large projects/programs in a regulated (preferably pharma) industry; 2+ years working with FDA on regulatory submissions.
- Preferred/Required: pharmaceutical drug safety/regulatory experience; program/project/vendor management; FDA REMS regulations knowledge; understanding of software systems and call center technologies.
- Technical skills/certifications: MS Word, Excel, PowerPoint, MS Project, database skills; strong FDA Regulatory knowledge.
- Also good to have: analysis/problem solving; interpersonal collaboration/negotiation/influencing; project management leadership; professional communication; MS365 tools.
Benefits (included)
- Comprehensive health insurance; 401(k) match and defined contribution; paid time off; company-paid life/disability; additional listed benefits.
Application Instructions
- Apply via Teva’s internal career site on Twist.
Travel Requirements
- About 15% domestic travel.
Essential Duties & Responsibilities
- Develop and manage Risk Management Programs (RiskMAPs, REMS with Elements to Assure Safe Use) with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance (20%).
- Vendor management (20%): evaluate/select vendors (per procurement policies), develop/manage vendor contracts, review/approve vendor invoices and program deliverables, monitor/report launch & operations progress, identify risks/issues, and seek management input/approval.
- Serve as Teva representative at industry working groups/consortiums collaborating on shared REMS programs (10%).
- Provide internal support for Regulatory documents; act as Regulatory expert on REMS matters; attend REMS program meetings; interface with Regulatory for REMS submissions (30%).
- Identify industry best practices for continuous improvement and cost-efficient operations (5%).
- Accountable for program budgets/financials (5%).
- Manage/coaching/mentoring one or more associates (10%).
Qualifications / Skills & Experience
- Education: Bachelor’s degree or equivalent combination of education and related experience; Preferred: Master’s degree in healthcare discipline or MBA.
- Experience: 7+ years (preferably 10) managing large projects/programs in a regulated (preferably pharma) industry; 2+ years working with FDA on regulatory submissions.
- Preferred/Required: pharmaceutical drug safety/regulatory experience; program/project/vendor management; FDA REMS regulations knowledge; understanding of software systems and call center technologies.
- Technical skills/certifications: MS Word, Excel, PowerPoint, MS Project, database skills; strong FDA Regulatory knowledge.
- Also good to have: analysis/problem solving; interpersonal collaboration/negotiation/influencing; project management leadership; professional communication; MS365 tools.
Benefits (included)
- Comprehensive health insurance; 401(k) match and defined contribution; paid time off; company-paid life/disability; additional listed benefits.
Application Instructions
- Apply via Teva’s internal career site on Twist.