Primary ResponsibilitiesĀ
⢠Provides advanced operational support to PRC team, and mentors less experienced employees on job duties and general clientĀ operationsĀ
⢠Manages PRC submission process including answering questions related to the submission processĀ
⢠Review all PRC submissions for completeness and accuracyĀ
⢠Tracks electronic review cycle and adherence to PRC planning calendars and timelinesĀ
⢠Manages logistics of meetings with PRC members including creation of the meeting agenda and recording comments during discussionsĀ
⢠Drives adherence with SOPs to improve PRC coordination and streamline PRC work processesĀ
⢠Provides input on workflow planning and prioritizationĀ
⢠Utilizing a document management system, maintains records for potential FDA audits, ensuring they are accurate and completeĀ
⢠Proofreads final submission and print layoutsĀ
⢠Provides editorial review of marketing materialsĀ
⢠Provide PRC SOP and system training to key stakeholders and agenciesĀ
⢠Collaborates cross-functionally with Regulatory, Medical, Legal, Marketing and AgenciesĀ
⢠Assists with FDA audits or other legal issues as neededĀ
⢠Works with PRC manager to develop processes and/or metrics and presenting to senior leadershipĀ
⢠Proactively provides logical recommendations and solutionsĀ
⢠Drives PRC consistencies across the organizationĀ
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC