Teva Director REMS Operations 

United States, New Jersey 

720005289

Travel Requirements

• 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.

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:

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. Strategic Thinking & Business Acumen
⦁ Thinks critically & creatively to make decisions that align with organization’s goals/objectives
⦁ Identifies gaps and opportunities, and ask strategic questions to gather trends and insights
⦁ Prioritizes tasks/projects based on the departmental needs to allocate resources efficiently

5. Communication
⦁ Delivers professional presentations and speaks effectively to both external and internal groups, or one on one
⦁ Understands and follows corporate confidentiality

6. 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
⦁ Uses knowledge and understanding of company policies and guidelines to apply in non-routine situations

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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.