Continued in previous role as company has transitioned to Veeva and led quality metrics input in Vault RIM for North and South America.

Support US Regulatory activities from a defined operations capacity. Providing many of the previous stated activities as a Regulatory Project Coordinator and expanding on previous experience by: providing publishing support for adverse event reporting to the FDA, review and coordinating site initiation package approvals with clinical team members, adding to preparing and executing multiple IND Annual Reports by also providing Orphan Drug Annual Reports to the health agency, building submissions in EPIC based on etcd standards and providing tracking support in insight manager for regulatory teams of over 16 products majority of them marketed.

Onsite contractor through Spectrum Inc. Provided labeling team support in such activities as the following examples: maintaining incident and corrective action tracker database, updating and formatting team SOP, informing all-staff of current international labeling updates/approvals, tracked core data sheet activities per product, computed monthly metric reports to track progress of all marketed labels world wide, and coordinated international team meetings to collaborate on process changes.

Onsite contractor through AppleOne Staffing. Participated in Global Regulatory Team to support development and execution of regulatory strategy. Assist Regional Regulatory Representative in regional regulatory activities such as routine submissions to the FDA. Coordinate collection of functional documents from each discipline in support of regulatory applications. Create and maintain product regulatory history documents and appropriately archive all regulatory documents in electronic databases. Review Global Regulatory Plan and provide input to operational deliverables

Responsible for balancing and ordering cash and office supplies. Lead for management and retention of all documents. Trainer for new employees. Scheduled and helped to maintain working teller line. Processed transactions for customers and business accounts including, but not limited to international wires, large cash deposits, withdrawals, and ATM deposits. Facilitated Financial Center's involvement in Light the Night fundraiser.

Worked as part of a team to accomplish time-sensitive deadlines. Conducted observation for the purpose of improving medical devices developed by the company.