Administrative Assistant

Location: Foster City, California
Posted On: 7/10/2017
Job Code: 2228_Administrative
Job Description
Title: Administrative Assistant
Duration: 12 months
Location: Foster City, California 94404

About the job:
This position needs to report to the Manager of PRC Operations, the Specialist, PRC has responsibility for managing the PRC process Reporting and serves as the primary point of contact for the PRC submissions. Excellent project management skills and communication skills are required.
Category:IT  code:new
Job Requirements
• Provides advanced operational support to PRC team(Promotion Review Committee), and mentors less experienced employees on job duties and general 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

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Contact Details
Varun Doshi
E-mail Address