[Remote] Director REMS Operations
Note: The job is a remote job and is open to candidates in USA. Teva Pharmaceuticals is a leading innovative biopharmaceutical company focused on addressing patients' needs. The Director, REMS Operations is responsible for the development and implementation of Risk Management Programs, coordinating with various departments to ensure compliance and effectiveness.
Responsibilities
- Work 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
- Provide 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
- Serve 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
- Proactively search for industry best practices & methods for continuous improvement of and cost-efficient operations
- Accountable for the departmental budget/financials
Skills
- Bachelor's degree or equivalent combination of education and related experience
- Minimum of 10, preferably 12 years of direct working experience managing large projects/programs in a regulated industry
- Minimum of 5 years working with FDA on regulatory submissions
- FDA Regulatory knowledge required
- Master's Degree in healthcare discipline OR MBA
- Pharmaceutical drug safety/regulatory experience
- Prior experience of vendor management/oversight
- Experience with software systems, call center technologies
- Understanding of FDA regulations on REMS
Benefits
- 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.
- Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
- Company paid Life and Disability insurance.
- 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.
Company Overview
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