PROMOTION REVIEW COMMITTEE SPECIALIST

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