Gwynedd-Mercy College, Gwynedd Valley, PA
Sandy Lewis is a Senior Director of Patient-Centered Outcomes Assessment at RTI-HS. She has more than 20 years of experience in the pharmaceutical industry, the majority of which has been focused on the development and validation of patient-reported outcome (PRO) measures and implementation of PROs within clinical trial programs. Ms. Lewis has supported developmental efforts for PRO evidence dossiers for submission to the Food and Drug Administration to support label claims. Throughout the span of her career, Ms. Lewis has worked in numerous therapeutic areas, including gastroenterology, neuropsychology, infectious diseases, respiratory, endocrinology, rheumatology, ophthalmology, orthopedics, urology, cardiovascular, and vaccines. Ms. Lewis has a strong interest in pediatric patient populations and has conducted numerous interviews with children and adolescents between the ages of 6 and 17. Additionally, Ms. Lewis has extensive experience in the standardization and development of training materials and instruction for the administration of multiple instruments and has supported the development and implementation of rater certification programs. During her tenure at Merck, Ms. Lewis was part of the Business Process Implementation team for incorporation of ePRO technology, which developed the guidance documents, working instructions, joint validation plan, and business processes surrounding adoption of the technology at the company. Ms. Lewis has strong project management skills and has wide-ranging experience in all aspects of data collection, from protocol development to report writing. Prior to entering the pharmaceutical arena, Ms. Lewis, a licensed registered nurse, worked for 3 years in a step-down critical care unit as a primary care nurse.