Associate Director, REMS 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, and additional listed benefits. #J-18808-Ljbffr Scorpion Therapeutics