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Director, REMS Operations
Date: Feb 7, 2025
Location:
Parsippany, United States, New Jersey, 07005
Company: Teva Pharmaceuticals
Job Id: 60677
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Director, REMS Operations is responsible for the development and implementation of Risk Management Programs/Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use. This individual plays a key role in the department by taking on responsibility to oversee/manage many complex REMS programs. This individual’s responsibilities include coordinating with Regulatory Affairs for timely approvals and communications with regulatory agencies, Sales & Marketing for on-time launches and ensuring stakeholder enrollment in the programs, Legal Affairs for reviewing the vendor contracts and industry agreements, Pharmacovigilance for safety monitoring & reporting, Medical Affairs for the development and review of educational materials, Quality Management & Compliance for audits, and Finance for program budgets. Additionally, the individual to have people management responsibility, with at least two managers reporting into.
Travel Requirements
About 25% of time to mostly domestic locations.
About 25% of time to mostly domestic locations.
The ideal candidate will be based in Parsippany, NJ, and able to work onsite. We are also open to candidates who can work out of our West Chester, MA office. For highly qualified candidates, remote work may be considered.
How you’ll spend your day
- Works closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs for a small portfolio of products
- Manages vendor relationships and engages with internal stakeholders. Provides vendor management
- 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 the management
- Serves as Teva Representative at the Industry Working Groups/Consortiums that collaborate towards shared REMS Programs
- Acts as internal expert for Teva on REMS related matters, attends REMS program meetings. Interfaces with Regulatory department for REMS document submissions.
- Identify opportunities to enhance REMS processes and implement best practices to improve efficiency and cost effectiveness
- Accountable for the departmental budget/financials
- People Leadership: Lead, mentor, and develop a team of professionals, fostering a collaborative and high-performance culture.
Your experience and qualifications
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:
- 10 or more years of direct working experience managing large projects/programs in a regulated industry. And Minimum of 5 years working with FDA on regulatory submissions. Must have people management experience
Experience Preferred:
- Prior experience in building and managing multiple complex REMS programs
- Prior experience of vendor management/oversight
- Experience with software systems, call center technologies
- Deep knowledge on REMS / Considered as REMS expert
- Proven ability to lead and develop teams, with strong people management and mentoring skills.
Functional Knowledge:
- FDA Regulatory knowledge required
Job-specific Competencies
1. 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
2. Interpersonal
- Exhibits excellent interpersonal skills and builds rapport when dealing with internal stakeholders, team members/coworkers, management and other external organizations
- Demonstrates strong collaboration, negotiation, influencing and management skills
3. Leadership and Teamwork
- Manages projects, sets priorities, meets deadlines, schedules and goals
- Manages a team of 2
4. Communication
- Delivers professional presentations and speaks effectively to both external and internal groups, or one on one
- Understands and follows corporate confidentiality
5. 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
Enjoy a more rewarding choice
We offer a competitive benefits package, including:
- Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
- Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
- Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
- Life and Disability Protection: Company paid Life and Disability insurance.
- The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
Already Working @TEVA?
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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.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
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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. Please, no phone calls or emails.
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