Admin Assistant

Location: Foster City, California
Posted On: 7/6/2017
Job Code: 2457_Admi_PRC
Job Description
• Reporting to the Manager of PRC Operations (Promotion Review Committee), the Specialist, PRC has responsibility for managing the PRC process and serves as the primary point of contact for the PRC submissions.
• Excellent project management skills and communication skills are required.

Primary Responsibilities
• 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

Knowledge and Skills
• Excellent project and task management skills including proactivity, planning, prioritization, objective setting, meeting management and plan execution.
• Execution and problem solving skills under pressure is core to this role.
• Applies an understanding of departmental goals to interpret information, draw conclusions, and make recommendations.
• Must be able to consistently perform work requiring a high level of attention to detail.
• Must have a good understanding of the pharmaceutical environment, relevant PRC process knowledge, and the ability to work proactively through the product review process.
• 3 years of relevant industry experience and a BA/BS degree; or zero years’ relevant experience with Master, MBA degree.
Category:IT  code:new
Job Requirements
Marketing, task management , PRC (Promotion Review Committee), SOP , document management system, Proofreads

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Contact Details
Neeraj Rathod
E-mail Address