Associate Director, REMS Operations

Our Team, Your Impact Associate Director, REMS Operations is responsible for the development and implementation of Risk Management Programs including RiskMAPs, REMS with Elements to Assure Safe Use. Works in coordination with Regulatory Affairs for timely approvals, Communications with regulatory agencies, Sales & Marketing for on‑time launches and stakeholder enrollment, Legal Affairs for vendor contract reviews, Pharmacovigilance for safety monitoring and reporting, Medical Affairs for educational materials, Quality Management & Compliance for audits, and Finance for program budgets. Travel Requirements Approximately 15% of the time spent traveling to domestic locations. Essential Duties & Responsibilities Work closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs (20%) Provide vendor management (20%) 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 management Serve as Teva Representative at the Industry Working Groups/Consortiums that collaborate toward shared REMS Programs (10%) Provide internal support for preparing regulatory documents, act as regulatory expert for Teva on REMS matters, attend REMS program meetings, interface with Regulatory department for REMS document submissions (30%) Proactively search for industry best practices & methods for continuous improvement and cost‑efficient operations (5%) Accountable for program budgets/financials (5%) Responsible for managing/coaching/mentoring one or more associates (10%) Your Skills And Experience Education Required: Bachelor’s degree or equivalent combination of education and related experience Education Preferred: Master’s Degree in healthcare discipline OR MBA Experience Required: Minimum 7, preferably 10, years of direct working experience managing large projects/programs in a regulated (preferably pharma) industry, and minimum 2 years working with FDA on regulatory submissions Experience Preferred: Pharmaceutical drug safety/regulatory experience Prior experience in program/project/vendor management General understanding of software systems, call center technologies Deeper understanding of FDA regulations on REMS Functional Knowledge: FDA Regulatory knowledge required Licenses, Certifications needed: MS Word, Excel, PowerPoint, MS Project, database skills Good to Have Analysis / Problem Solving Demonstrates ability to analyze and interpret information, reports and data Demonstrates appropriate judgment and ability to make decisions regarding access to Teva resources Interpersonal Exhibits excellent interpersonal skills and builds rapport with internal stakeholders, team members, management and external organizations Demonstrates strong collaboration, negotiation, influencing and management skills Leadership and Teamwork Manages projects, sets priorities, meets deadlines, schedules and goals Communication Delivers professional presentations and speaks effectively to both external and internal groups or one on one Understands and follows corporate confidentiality Technical Skills 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 Understands and uses MS365 tools effectively Salary Range The annual starting salary for this position is between $159,000 and $194,000, inclusive of potential factors such as geography, skills, education, experience and other qualifications. How We’ll Take Care Of You We offer a competitive benefits package, including: 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 401(k) plan Paid Time Off: vacation, sick/safe time, caretaker time and holidays Life and Disability Protection: Company‑paid life and disability insurance Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Lifestyle 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 Restricted stock units and discretionary awards may also be part of total compensation Location and Hybrid Basis This role could be based out of our Parsippany, NJ facility or West Chester, PA facility on a hybrid basis. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided 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 status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Accommodations All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. Request a reasonable accommodation by sending an email to View email address on click.appcast.io with the nature of your request and your contact information. Important Notice to Employment Agencies Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. No phone calls or emails. #J-18808-Ljbffr Teva Pharmaceuticals