Corproate Experience by Deborah Shatin

CORPORATE EXPERIENCE

Medtronic, Inc., Neurological Division (12 years)

Conducted global, multi-center, longitudinal medical device clinical trials, including research design, case report forms, data retrieval, site monitoring, and regulatory compliance, as well as technology transfer to U.S. clinical sites
Submitted and obtained FDA approvals for study protocols and pre-market applications (510 (k), IDE’s, PMA’s)
Investigated safety and efficacy of new neurological, orthopedic, and vascular disease products
Designed and conducted post market surveillance and indication extension studies of medical devices
Implemented outcome studies of medical technologies for the treatment of chronic pain and movement disorders; conducted the first outcomes study at the company
Instructed colleagues on quality training and served on Medical Device Reporting Board
Managed neurological clinical studies department of eight, including CRMs, CRA’s, programmers
Directed and coordinated simultaneous clinical studies on budget and on schedule

Center for Health Care Policy and Evaluation, UnitedHealth Group (11 years)

Obtained annual research funding levels of $1.3 M, $5 M overall, with more than 25 studies funded
Directed large-scale national managed care pharmacoepidemiology and health care studies using national claims databases, medical record abstractions, and surveys
Conducted FDA post marketing drug safety surveillance with FDA/CDER as Principal Investigator (PI) for ten years; one of only three sites nationally
Conducted post-licensing biologic safety surveillance for FDA/CBER (biologics and vaccines) as PI; received the only national award for four task orders
Successfully collaborated on research with five of the seven original Centers for Education and Research on Therapeutics (CERTs), showing national recognition of ability to complete health research studies and translate research into practice
Researched risk management and risk communication for drugs and biologics, studying both adverse events and labeling compliance
Obtained agency funding and conducted population- based health research including surveillance of infectious diseases (TB, Hepatitis C) and chronic diseases (cardiovascular, diabetes, MS)
Developed HIPAA implementation, IRB approval process, and research compliance training
Directed and coordinated simultaneous research projects on varied topics within budget and on schedule