The Manager, Risk Evaluation and Mitigation Strategy (REMS) manages the activities for all Alexion REMS Program across the product portfolio to ensure compliance with Food and Drug Administration (FDA) requirements, including implementing product safety activities and additional risk management activities. The jobholder provides internal direction and accountability for the company’s REMS programs and day-to-day management of key risk management vendors as needed. The Manager plays a pivotal role in managing timelines and deliverables for key risk management milestones for the company. The Manager, REMS reports to the Regional Director Safety Excelellece, US & Canada.
Job Duties & Responsibilities
Manages the planning, implementation and execution of activities related to the development and ongoing administration of REMS programs for all Alexion products ensuring compliance with FDA requirements. Accountable for the following:
- Under the direction of the Regional Director Safety Excelellece, US & Canada develops REMS strategy for joining new programs and is responsible for proper documentation of the process through the creation of Standard Operating Procedures (SOPs) and Work Instructions.
- Collaborates with Regulatory Affairs (e.g. Risk Management Physicians) and other functional teams to compile REMS submissions and reports to the Food and Drug Administration (FDA) for approval; leads the response to FDA questions and requests for additional information during REMS negotiations.
- Develops and maintains department Standard Operating Procedures (SOPs) and working practices to support compliant infrastructure.
- Collaborates with Risk Management Physicians on the creation of communications, materials, and documentation for mitigation activities.
- Manages the day-to-day oversight of the vendor which performs activities involved in the physician enrollment process and ensures 100% of the prescribers are enrolled in the REMS.
- Monitors external environment for regulatory changes impacting risk management.
- Establishes, implements and tracks key metrics to report on progress of all initiatives; ensures integrity of data provided in REMS Assessment reports.
- Serves as a technical consultant to business development & licensing, marketing, and research & development to conduct product risk assessment.
- Sets and manages overall project timelines and budgets/ financials for assigned projects.
- Acts as the primary Subject Matter expert for REMS inspections and internal audits.
- Develops and ensures implementation of Corrective and Preventative actions (CAPAs) raised as a result of inspections or audits in relation to REMS.
Supports the evaluation, selection and ongoing activities of vendors involved in REMS programs. Accountable for the following:
- Drafts requests for proposals andcontracts with the involvement of key stakeholders within Alexion
- Reviews of deliverables, performs invoice review.
- Attends all REMS program meetings with vendors as necessary to ensure vendor compliance with established programs.
- Knowledge of Good Pharmacovigilance Practices (GVP), FDA REMS regulations and guidelines, and applicable international RM regulatory requirements.
- Experience working on global and complex risk management programs 21 CFR, Part 211 and 312, GXP's.
- Effective problem-solving and the ability to work independently under tight deadlines.
- Very strong written and verbal communication skills.
- Working knowledge of Microsoft Word, Excel and PowerPoint.
- Critical thinker, intellectually creative and with ability to synthesize, analyze and critique data.
- Strong leadership skills, as well as experience working in a matrix environment and managing important vendor relationships
- Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
- Advanced scientific degree (e.g. Pharm.D or PhD) with a minimum of 5 years of REMS or Risk Management experience.
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.