Director REMS Operations
Teva Pharmaceuticals
July 02, 2026
Remote friendly (Parsippany, NJ)
United States
Operations
Director, REMS Operations
Responsibilities:
- Develop and implement Risk Management Programs, including RiskMAPs and REMS with Elements to Assure Safe Use.
- Coordinate with Regulatory Affairs, Sales & Marketing, Legal Affairs (vendor contracts/industry agreements), Pharmacovigilance (safety monitoring/reporting), Medical Affairs (educational materials), Quality Management & Compliance (audits), and Finance (budgets).
- Work closely with cross-functional teams to develop and manage Risk Management Programs for a small portfolio of products.
- Provide vendor management: evaluate/select vendors (per procurement policies), develop/manage vendor contracts, review/approve vendor invoices and program deliverables, and monitor/report launch/operations progress; identify risks/issues and seek management input/approval.
- Serve as Teva representative in industry working groups/consortiums for shared REMS programs.
- Serve as internal REMS expert; attend REMS program meetings; interface with Regulatory for REMS document submissions.
- Identify industry best practices for continuous improvement and cost-efficient operations.
- Accountable for departmental budget/financials.
Qualifications:
- 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): 10+ years (preferably 12) managing large projects/programs in a regulated industry; 5+ years working with FDA on regulatory submissions.
- Experience (Preferred): pharmaceutical drug safety/regulatory; vendor management/oversight; software systems/call center technologies; understanding of FDA REMS regulations.
- Functional Knowledge: FDA regulatory knowledge required.
Skills/Competencies:
- Analysis/problem solving; interpret data/reports; sound judgment.
- Interpersonal, collaboration, negotiation, influencing.
- Leadership/teamwork; project management; manage a team of 3.
- Communication; professional presentations; confidentiality.
- Technical skills in project management; knowledge of FDA regulations and post-authorization patient safety/compliance programs; software/call center technology.
Application instructions:
- Apply via Teva’s internal career site on Twist.
Responsibilities:
- Develop and implement Risk Management Programs, including RiskMAPs and REMS with Elements to Assure Safe Use.
- Coordinate with Regulatory Affairs, Sales & Marketing, Legal Affairs (vendor contracts/industry agreements), Pharmacovigilance (safety monitoring/reporting), Medical Affairs (educational materials), Quality Management & Compliance (audits), and Finance (budgets).
- Work closely with cross-functional teams to develop and manage Risk Management Programs for a small portfolio of products.
- Provide vendor management: evaluate/select vendors (per procurement policies), develop/manage vendor contracts, review/approve vendor invoices and program deliverables, and monitor/report launch/operations progress; identify risks/issues and seek management input/approval.
- Serve as Teva representative in industry working groups/consortiums for shared REMS programs.
- Serve as internal REMS expert; attend REMS program meetings; interface with Regulatory for REMS document submissions.
- Identify industry best practices for continuous improvement and cost-efficient operations.
- Accountable for departmental budget/financials.
Qualifications:
- 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): 10+ years (preferably 12) managing large projects/programs in a regulated industry; 5+ years working with FDA on regulatory submissions.
- Experience (Preferred): pharmaceutical drug safety/regulatory; vendor management/oversight; software systems/call center technologies; understanding of FDA REMS regulations.
- Functional Knowledge: FDA regulatory knowledge required.
Skills/Competencies:
- Analysis/problem solving; interpret data/reports; sound judgment.
- Interpersonal, collaboration, negotiation, influencing.
- Leadership/teamwork; project management; manage a team of 3.
- Communication; professional presentations; confidentiality.
- Technical skills in project management; knowledge of FDA regulations and post-authorization patient safety/compliance programs; software/call center technology.
Application instructions:
- Apply via Teva’s internal career site on Twist.