Mary Brainadette Grande

• Leading, supervising, and managing a team of regulatory data specialists who perform various tasks in a fast-paced regulatory records and Information operation

• Monitoring and overseeing the processing of regulatory data and ensuring the final data elements are ready for output to a variety of printed and electronic media

• Analyzing issues or problems and work quickly to identify solutions using independent judgment while ensuring data integrity, efficiency, and accuracy are maintained

• Creating business processes and workflows that map to regulatory standards

• Maintaining accurate and up-to-date project documentation, including statistics, SOPs, and reports

• Demonstrating knowledge and skills in areas of regulatory compliance and data management

• Developing and maintain positive relationships with FDA contacts through oral and written communications regarding the processing of regulatory data

• Ensuring team members are effectively trained and coached on duties/tasks and current policies and procedures

• Working closely with the Project Manager to monitor production, productivity, quality, and customer service standards adhere to expected levels and contract requirements

• Detail oriented with organizational skills, team building, and collaboration skills

• Responsible for daily preparation, checking, and printing mail outsof Compliance Check Inspection in accordance with the FDA Center for Tobacco Products guidelines• Reviewing and retrieving system data, based on pre-defined procedures and evaluating whether information entered into database is complete and accurate• Responsible for the distribution of work assignments within the team• Escalating identified problems or issues to the next level supervisor for resolution• Responsible for communicating all issues that impact the quality or timely completion of the recording process to the Team Lead and Supervisor• Maintains accurate up-to-date knowledge of specialized applications and upgrades to achieve maximum efficiency and productivity with the Document Services applications, such as Compliance Check Inspection, Non-Response and Warning Letter Response uploads• Proficient in utilizing databases of FDA (TIMS, ECMS & MARCs)• Demonstrated understanding and experience using Excel and other MS-Office products• Ability to organize and prioritize multiple assignments, use initiative and judgment to accomplish results, work under pressure and produce extremely accurate and detailed work within established timeframe and quality standards• Strong communication, interpersonal, teamwork and customer service skills and ability to interact effectively and professionally with all levels of management and staff• Providing feedback to my team members whenever there is a discrepancy or any inconsistency with their work• Perform quality assurance on spreadsheets to be submitted by our team regarding data entered into the FDA system• Ensuring new team member are effectively trained and coached on a given tasks• Detail oriented with organizational skills• Reporting to a Regulatory Data Specialist Lead and immediate Supervisor and collaborating on various activities with team members• Other tasks assigned- Training new hired employee

• Responsible for daily preparation, checking and printing mail outsof Compliance Check Inspection in accordance with the FDA Center for Tobacco Products guidelines• Responsible for communicating all issues that impact the quality or timely completion of the recording process to the Team Lead and Supervisor• Maintained up-to-date knowledge of specialized applications and upgrades to achieve maximum efficiency and productivity with the Document Services applications• Proficient in utilizing databases of FDA (TIMS, ECMS & MARCs)• Demonstrated understanding and experience using Excel and other MS-Office products• Ability to organize and prioritize multiple assignments, use initiative and judgment to accomplish results, work under pressure and produce extremely accurate and detailed work within established timeframe and quality standards• Strong communication, interpersonal, teamwork and customer service skills and ability to interact effectively and professionally with all levels of management and staff

• Working in a high-volume, fast-paced, deadline driven production environment processing cash and check deposits
• Performed entry level general operation tasks that are repetitive in nature within the CTS document custody vault
• Duties by means of the documents or collateral files may include: filling, sorting, photocopying, pull collaterals to be released to the customer and scan barcodes all according to departmental expectations, receiving requests for release
• Performed routine shifting of files to accommodate new inventory
• Assisted with special projects and duties as assigned
• Conducted deposit verification and or change order preparation using specialized counting equipment and procedures• Separated currency, coin and or check deposits received from bank, ATM and or commercial customers providing accurate count by denomination• Prepared currency and or change orders by denomination for each customer assigned• Consolidating