? The Specialist acts as primary point of contact responsible for execution of RPE responsible entries and/or updates within various GRACS Tools [ORION, RADR, USPT, etc.].
? The Specialist works closely with the RPE Tool Functional System Expert (FSE), Regulatory Submission Managers and stakeholders, such as Tool Owners within Innovation & Information Management (IIM), to support the quality review of RPE data within the various tools.
? In collaboration with the Regulatory Submission Manager (RSM), assesses and communicates any risks/ issues that could impact the successful entry of regulatory data.
? May assist the RSM in day to day project management activities associated with program development/maintenance.
? Helps identify and assist with solutioning of business process improvement opportunities, documentation updates and/or training to prevent practices which could lead to quality deviations or non-compliance events
? Liaises with all pillars of the RPE organization to ensure timely and quality data entry into the various GRACS tools, as the business requires This is a new role - They are building a center of excellence - There will be multiple emails a day from larger team to triage and prioritize. Candidate will have conversations with multiple stakeholders to confirm data and accuracy. This role is very much about providing a customer service experience.
Administrative Support, Regulatory Submission