Manage the Promotional Review Committee (PRC) process end-to-end and act as a project manager for the PRC, Marketing, and other cross-functional stakeholders in order to ensure accurate, timely, and compliant review of materials
Schedule PRC meetings serving as the point of contact for meeting coordination
Facilitate and document required changes and comments as part of PRC during meetings
Manage product label updates and collaborate with cross-functional stakeholders to ensure materials are revised, resubmitted for PRC Review, and submitted to FDA on form 2253
Ensure consistency and quality of PRC submissions
Maintain the promotional material library to ensure active/approved materials are re-reviewed per internal guidelines
Monitor daily operations and adherence to SOP(s)
Create and manage timely submissions of promotional materials to the FDA (i.e. FDA 2253, Request for Advisory Comments)
Ensure that projects are completed on schedule following established procedures and timelines as it relates to the PRC process and submissions to the FDA
Participate in ongoing PRC Operational projects to enhance efficiencies in Kite PRC processes
May represent group in cross-functional and Regulatory Affairs working groups and present project status updates to group
Maintain Kite US Reference Library standards and associated Claims
