Wound Care Utilization Management RN Elevance Health IncWound Care Utilization Management RNWilmington, DE$39.34–$56.20 / hourThe Wound Care Utilization Management RN will be responsible for performing pre-certification and/or authorization activities for Home Health Services for members with wound care needs included as contracted services that meet eligibility and benefits coverage. For the Wound Care Connect program, in addition to Wound Care Certification requirements above, Ostomy training through accredited programs such as WOCN or ABWM and Ostomy experience is also required.
Director / Associate Director Companion Diagnostics Lead, Translational Sciences Incyte CorpDirector / Associate Director Companion Diagnostics Lead, Translational SciencesWilmington, DEKey duties include Serve as subject matter expert in CDx development process from concept to commercialization Lead selection and management of diagnostic partners Monitor assay analytical and clinical performance evaluation activities Author CDx related parts across documents Ensure CDx representation in cross-functional teams Serve as alliance and project manager between Incyte and key diagnostic partners Generate and review new project agreements as needed Manage and maintain CDx budget for projects Track and approve milestones for each project Lead Joint project team JPT meetings with alliance partner Supervise validation and implementation of clinical trial assay CTA at testing laboratory Maintain alignment between diagnostics partner and testing laboratory Ensure timelines are met Oversee operational aspects of clinical implementation Ensure compliance with regulatory and ethical guidelines Develop and apply expertise in regulatory requirements for CDx across regions US FDA EU IVDR etc Supervise Incyte review of CDx documentation such as clinical study performance plans CPSP Instructions for Use etc Ensure creation and review of informed consent CPSP and country submissionsresponses are timely and compliant Develop and Maintain Expertise in Delivery of Companion Diagnostics Maintain relationships with key stakeholders Qualifications Minimal acceptable level of education work experience and competency Minimum BS Degree in a scientific discipline with 7 years of experience in the diagnostic andor pharmaceutical industry clinical studies. Job Summary Primary function Associate Director Companion Diagnostics Lead is a leadership role responsible for the development and implementation of clinical diagnostic plans including companion diagnostics CDx requirements within drug development programs.