Mesa, Arizona, United States
Key Responsibilities Include: • Develop and lead REMS strategy, operations, activities, and team management for U.S. • Provides internal direction, leadership, and accountability for the Empaveli REMS and day to day management of the vendor as applicable • Escalate issues related to vendor performance, compliance, and/budget to manager • Review all REMS related documents and approve as required • Collaborate and lead cross-functional teams to develop and implement REMS operational processes • Collaborate with Regulatory to interpret U.S. guidelines and implement regulatory activities related to the REMS program • Serve as subject matter expert for internal teams through all stages of the REMS U.S. program development and ongoing management • Ensure consistent REMS inspection readiness of cross functional team including maintaining proper documentation of program • Oversee vendor partnerships, vendor activities and REMS Coordinating Center • Oversee and Coordinate development of quality REMS Assessment Reports and other REMS submission(s) to agreed timelines • Collaborate with Quality to ensure that REMS Audit Plan is executed • Conduct regular assessments of operations and implement changes that drive program effectiveness, customer satisfaction, and appropriate product access • Ensure communication to appropriate team members and management as needed
Acquired by Biogen Key Responsibilities Include: • Develop and lead REMS strategy, operations, activities, and team management for U.S. • Provides internal direction, leadership, and accountability for the Empaveli REMS and day to day management of the vendor as applicable • Escalate issues related to vendor performance, compliance, and/budget to manager • Review all REMS related documents and approve as required • Collaborate and lead cross-functional teams to develop and implement REMS operational processes • Collaborate with Regulatory to interpret U.S. guidelines and implement regulatory activities related to the REMS program • Serve as subject matter expert for internal teams through all stages of the REMS U.S. program development and ongoing management • Ensure consistent REMS inspection readiness of cross functional team including maintaining proper documentation of program • Oversee vendor partnerships, vendor activities and REMS Coordinating Center • Oversee and Coordinate development of quality REMS Assessment Reports and other REMS submission(s) to agreed timelines • Collaborate with Quality to ensure that REMS Audit Plan is executed • Conduct regular assessments of operations and implement changes that drive program effectiveness, customer satisfaction, and appropriate product access • Ensure communication to appropriate team members and management as needed
- Managed two large multi-sponsor Risk Evaluation Mitigation Strategy (REMS) programs, including development and ongoing maintenance of all aspects of the programs. - Provided constructive verbal and written feedback to consulting staff team members on project deliverables and client/team interactions. - Acted as the primary point of contact for all sponsor interactions. - Developed, implemented, and continued to manage complex budgets, including budgets with over $1,000,000 in direct revenue. - Managed vendor-sponsor interactions, including assisting with vendor identification and contracting. Tracked vendor deliverables and ensures accuracy prior to client review. - Assisted in development and launch of a multi-sponsor, multi-vendor REMS program with Elements to Assure Safe Use (ETASU). About Syneos Health Consulting: Built on the combination of Campbell Alliance and Kinapse, Syneos Health Consulting is a leading management consulting firm specializing in the life sciences industry and is a part of Syneos Health, only fully integrated end-to-end clinical and commercial solution organization. We provide deep subject matter expertise over the entire lifecycle of an organization, portfolio or asset and our unique ability to leverage end-to-end capabilities and global functional and therapeutic experts results in highly customized solutions. Deep pre- and post-launch expertise generates strategic insights that yield implementation-focused recommendations designed to reduce risk, speed time to market and increase overall asset and portfolio value.
Responsible for handling the development, implementation, and assessment of a REMS and general US risk management strategy. - Coordinated the risk management strategy in collaboration with cross-functional team. - Developed and drove strategy and operations. - Ensured communication to appropriate team members, global teams, and management, as needed. - Primary representative for RRM CoE on cross-functional REMS team. - Represented RRM CoE to assigned external teams. - Lead vendor activities, operational development, and management of assigned REMS. - REMS Industry Consortium (RIC) Education & Certification Co-Lead