Director REMS Operations 1

We Are TevaWe’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 ImpactThe 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 DayWork closely with Regulatory Affairs, Sales & Marketing, Medical Affairs, and Pharmacovigilance in the development and management of Risk Management Programs for a small portfolio of productsProvide vendor managementEvaluate and select vendors according to Teva’s procurement policies where applicableDevelop and manage vendor contractsReview and approve vendor invoicesReview and approve program deliverablesMonitor 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 ProgramsActs as internal expert for Teva on REMS related matters, attends REMS program meetings. Interfaces with Regulatory department for REMS document submissionsProactively search for industry best practices & methods for continuous improvement of and cost-efficient operationsAccountable for the departmental budget/financialsYour Skills and ExperienceEducation Required: Bachelor’s degree or equivalent combination of education and related experienceEducation Preferred: Master’s Degree in healthcare discipline OR MBAExperience Required: Minimum of 10, preferably 12 years of direct working experience managing large projects/programs in a regulated industry. And Minimum of 5 years working with FDA on regulatory submissionsExperience Preferred:Pharmaceutical drug safety/regulatory experiencePrior experience of vendor management/oversightExperience with software systems, call center technologiesUnderstanding of FDA regulations on REMSFunctional Knowledge: FDA Regulatory knowledge requiredAlso Good to HaveAnalysis / Problem SolvingDemonstrates ability to analyze and interpret information, reports and dataDemonstrates appropriate judgment and ability to make decisions regarding access to Teva resourcesInterpersonalExhibits excellent interpersonal skills and builds rapport when dealing with internal stakeholders, team members/coworkers, management and other external organizationsDemonstrates strong collaboration, negotiation, influencing and management skillsLeadership and TeamworkManages projects, sets priorities, meets deadlines, schedules and goalsManages a team of 3CommunicationDelivers professional presentations and speaks effectively to both external and internal groups, or one on oneUnderstands and follows corporate confidentialityTechnical SkillsDemonstrates project management skillsDemonstrates knowledge of FDA regulations, requirements and guidance documents relevant to pharmaceutical product post authorization patient safety / compliance programsExcellent understanding of issues related to software development and call center technologiesAbility to use knowledge and understanding of company policies and guidelines to apply in non-routine situationsThis role offers Hybrid flexibility to our Parsippany, NJ or West Chester, PA office.How We’ll Take Care of YouWe 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.  Already Working @Teva?Make sure to apply through our internal career site on Twist—your one-stop shop for career developmentTeva’s Equal Employment Opportunity CommitmentTeva 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 View email address on click.appcast.io 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.   Important notice to Employment Agencies - Please Read Carefully 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.   Department:Regulatory Affairs