Associate Director, REMS Operations

We Are Teva

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You''ll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

The Associate Director, REMS Operations is responsible for the development and implementation of Risk Management Programs including RiskMAPs, REMS with Elements to Assure Safe Use.

This individual works in coordination 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.

How You'll Spend Your Day

Travel Requirements

About 15% of time to mostly 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 the management

• Serve as Teva Representative at the Industry Working Groups/Consortiums that collaborate towards shared REMS Programs (10%)

• Provides internal support for preparing Regulatory documents and acts as Regulatory expert for Teva on REMS related matters, attends REMS program meetings. Interfaces with Regulatory department for REMS document submissions (30%)

• Proactively search for industry best practices & methods for continuous improvement of and cost-efficient operations (5%)

• Accountable for the 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 of 7, preferably 10 years of direct working experience managing large projects/programs in a regulated (preferably in pharma) industry. And Minimum of 2 years working with FDA on regulatory submissions
• Experience Preferred:
• Pharmaceutical drug safety/regulatory experience
• Prior experience of program/project/vendor management
• General understanding of software systems, call center technologies
• Deeper understanding of FDA regulations on REMS
• Specialized or Technical Knowledge Licenses, Certifications needed: MS Word, Excel, PowerPoint, MS Project, database skills
• Functional Knowledge: FDA Regulatory knowledge required

Also 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 when dealing with internal stakeholders, team members/coworkers, management and other 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

This role could be based out of our Parsippany, NJ facility or West Chester, PA facility on a Hybrid basis

Salary Range

The annual starting salary for this position is between $159,000-$194,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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, 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.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style 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 and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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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 AskHR@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.