Dini User

Led cross-functional coordination for 7T spectrometer & 3T MRI patient table development projects, overseeing design verification testing and managing resource allocation. Managed engineering change orders, facilitated biweekly meetings, and tracked action items. Reviewed and formulated key documentations, including System Requirement Specification, Functional Specification and Design Specificatio

Executed qualification testing to ensure compliance with URAC standards for the shipment of refrigerated and non-refrigerated medications, supporting regulatory and supply chain operations. Led proactive risk assessments for the Truqap program, developing a monitoring platform to identify and address potential supply chain issues. Managed an average of 30 oncology patient assistance program applic

Gained experience in FDA regulatory processes and policy for clinical development, post-marketing pharmacovigilance, and medical devices. Conducted analysis of clinical designs for 18 inflammatory bowel disease (IBD) drugs and summarized experimental data for 20 FDA-approved IBD medications, focusing on regulatory compliance and dosage selection strategies. Created detailed reports on pediatric an

Conducted cost-effectiveness analyses on chronic heart failure medications as part of the Creating Customer Value project. Reviewed policies and performed market level insurance plan analyses, ensuring alignment with industry and regulatory standards. Supported the development of a Provider Facing Analysis Tool, integrating regulatory insights to optimize medication utilization and enhance cost-sa

Pursued advanced studies in pharmacy practice, clinical sciences, and pharmaceutical care. Focused on patient-centered care, medication therapy management, and regulatory compliance.

Completed foundational coursework in pharmaceutical sciences, including chemistry, biology, and pharmacology. Developed a strong understanding of drug discovery, development, and analysis.