Primary Responsibilities
• Provides advanced operational support to PRC team, and mentors less experienced employees on job duties and general client operations
• Manages PRC submission process including answering questions related to the submission process
• Review all PRC submissions for completeness and accuracy
• Tracks electronic review cycle and adherence to PRC planning calendars and timelines
• Manages logistics of meetings with PRC members including creation of the meeting agenda and recording comments during discussions
• Drives adherence with SOPs to improve PRC coordination and streamline PRC work processes
• Provides input on workflow planning and prioritization
• Utilizing a document management system, maintains records for potential FDA audits, ensuring they are accurate and complete
• Proofreads final submission and print layouts
• Provides editorial review of marketing materials
• Provide PRC SOP and system training to key stakeholders and agencies
• Collaborates cross-functionally with Regulatory, Medical, Legal, Marketing and Agencies
• Assists with FDA audits or other legal issues as needed
• Works with PRC manager to develop processes and/or metrics and presenting to senior leadership
• Proactively provides logical recommendations and solutions
• Drives PRC consistencies across the organization