Tri Le Email & Phone Number

Silver Spring, Maryland, United States

CDER Office of Compliance, Office of Manufacturing QualityActing Operations Team Leader (October 2020 to June 2021)Permanent Operations Team Leader (July 2021 to September 2024)Regulatory Compliance & Analysis Staff Team Leader (October 2024 to Present)• Lead motivated and talented staff with areas of responsibility including data analytics, operations, and program management• Develop, implement, and manage multiple internal tracking systems covering important Office programs• Deliver presentations and trainings to stakeholder groups within and outside the Office• Lead operational effort to implement the execution of the Mutual Recognition Agreement (MRA) between the FDA and European Union regulatory authorities• Oversee pharmacy student participants in the Pharmacy Student Experiential Program and the OMQ Internship Program

Silver Spring, Maryland

CDER Office of Compliance, Office of Manufacturing Quality, Program Operations• Provide metrics and data analytics support to the Office, including creation and presentation of detailed trend analysis, data visualizations, and management dashboards using Tableau and other software• Develop, implement, and maintain business process improvements including creation of standard operation procedures, work aids, and templates• Formulate and manage methods to improve tracking of pending actions against non-compliant firms• Lead Office effort to implement the execution of the Mutual Recognition Agreement (MRA) between the FDA and European Union regulatory authorities• Oversee pharmacy student participants in the Pharmacy Student Experiential Program

Silver Spring, Maryland

CDER Office of Compliance, Office of Program and Regulatory Operations, Program Management and Coordination Staff I• Supported the execution of the Drug Supply Chain Security Act (DSCSA) through strategic planning, project management, process management, and coordination of projects• Worked with the Office of Drug Security, Integrity, and Response (ODSIR) on guidance and regulation development• Assessed and strategically planned the wholesale drug distributor and third-party logistics provider licensure compliance program, considering statutory and resource requirements and limitations• Coordinated and facilitated meetings• Served as liaison between various stakeholders within and outside the Agency• Developed, generated, and analyzed reports to highlight the progress and opportunities of public health initiatives required by DSCSA

• Serve as APPE preceptor for Rutgers Ernest Mario School of Pharmacy for twenty students

• Provided pharmaceutical care in an efficient and professional manner• Counseled patients on prescription and over-the-counter medications• Educated patients and healthcare professionals about corporate initiatives and company services

Stirling, Nj

• Owned the management of the workflow and business operations of the pharmacy• Successfully used analytics to anticipate drug supply demands and prevent inventory issues• Supervised, trained, and mentored staff pharmacists, pharmacy interns, and technicians• Resolved customer service issues are escalated through technicians and pharmacists• Cross-trained in specialty retail and fertility sites• Selected by pharmacy supervisor to travel to new store locations across the country to properly prepare the store for opening and train new staff

• Compounded and dispensed medication under registered pharmacist’s supervision• Resolved third party issues regarding patient prescriptions• Organized medications and assisted in rearranging pharmacy layout

• Developed content and progress check questions for sales representatives training modules• Evaluated and updated medical literature references for training modules• Quality tested scientific sales aid tools