The Manager, REMS Programs is responsible for managing risk mitigation activities for Indivior’s Risk Evaluation and Mitigation Strategy (REMS) programs related to product specific and/or class-wide REMS requirements.
The responsibilities of this job include, but are not limited to, the following:
Execute operational aspects of assigned REMS Program activities as well as special projects
Coordinate and facilitate all REMS program meetings with internal stakeholders as necessary
Responsible for leading projects with cross-functional involvement
Help lead process improvement activities
Establish, implement and track key metrics to report on progress of all initiatives
Responsible for proper documentation of all processes through the creation of Standard Operating Procedures (SOPs), Work Instructions, and/or Project Management Plans
Develop and maintain department SOPs and working practices to support compliant infrastructure
Establish and manage overall project timelines and budgets for assigned projects
Collaborate with Regulatory Affairs and other cross-functional teams on applicable REMS submissions and reports to the Food and Drug Administration (FDA)
Contribute to the development of REMS Assessment Reports on annual basis
Assist (SM-RM) to provide vendor management including managing of requests for proposals from initial request through coordinating and clarifying responses (as required), develop and manage contracts with the involvement of key stakeholders within Indivior, invoice reviews and approvals, evaluation and selection and deliverable reviews
Assist (SM-RM) in developing REMS strategy for new and modified REMS programs, as applicable
Assist (SM-RM) in tracking financials based on approved budgets/forecasts and invoices
Monitor external environment for regulatory changes impacting risk management
Education: Graduate or higher degree (PhD, Pharm D, or Master's degree) in a science or healthcare related discipline with specialty training in functional area preferred. Will consider Bachelor’s Degree with equivalent years of education and experience.
Minimum 5 years of working in a regulated environment.
Proficient in Microsoft Word, Excel, PowerPoint, MS Project, SharePoint, Adobe Acrobat and SharePoint
Demonstrated Project Management experience
Demonstrated vendor management and oversight
Demonstrated business and data analytics abilities
In addition to the minimum qualifications, the employee will demonstrate:
Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
Excellent interpersonal, communication, presentation and influencing skills
Critical thinker, intellectually creative with ability to synthesize, analyze and critique data
Strong leadership skills, as well as experience managing successful working relationships in a cross-functional, matrix environment
Ability to multi-task, think critically and creatively, excellent time-management skills, ability to deliver high-quality effective follow up communications
Drive for self-development, ability to collaborate, and an action-oriented work ethic
Experience within the life sciences/pharmaceutical industry with focus on risk mitigation, compliance, audit, and/or pharmacovigilance
Familiarity and exposure to REMS and risk management programs, submissions and implementation
Experience managing a REMS program with Elements to Assure Safe Use (ETASU)
Demonstrated competence in procedural medical/regulatory writing
Call Center activity oversight
Development of training materials for adult learners
Demonstrated project management experience and/or certifications
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes
3 weeks’ vacation plus floating holidays and sick leave
401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
U.S. Employee Stock Purchase Plan- 15% Discount
Comprehensive Medical, Dental, Vision, Life and Disability coverage
Health and Dependent Care Flex Spending options
Leverage Concierge/ personal assistance services
Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
Gyms, fitness facilities and cell phone discounts
Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.