Responsible for delivery of site activation readiness, preparation of Clinical Trial Application Forms, and interaction with CA/EC for study purposes. Providing updates about submissions, maintaining project plans, and customizing Patient Information Sheets. Act as SME for collection and maintenance of site level critical path to Site Activation data points. May support the clinical team performing Pre-Study Site Visits.
Job listings
$140,000–$150,000
USD/year
Supports North America Regulatory activities and ensures timely preparation and completion of technical file submissions for in vitro diagnostic devices to meet project and business needs. This role requires participating on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements, develop North America regulatory strategies plan for submission for IVD products, and assess changes to product and manufacturing processes.