Statement of Intent
As a talented scientist and analytical problem-solver, I desire to utilize my expertise in drug safety, regulatory affairs and pharmacovigilance to advance pharmaceutical/biotechnology products to market and beyond.
Biography
I like to descibe myself as a generalist - in the fact that I have a wide-ranging background in multiple areas, settings and disciplines allowing myself to effectively handle new challenges. Specifically, my experience covers various realms including pharmacovigilance, regulatory affairs, drug safety, pharmacology/toxicology as well as research & development. Furthermore I have experience in various categories, including biologics, drugs, devices and dietary supplements. I have worked in various settings which include an over-the-counter (OTC) healthcare products company, a teaching hospital, a research university and a biotechnology company. Although I have a broad scientific background, I hold specialized knowledge in the areas of immunology, oncology, and pathogenesis. I possess experience ranging from clinical trials to molecular assays as well as extensive experience in non-clinical in vitro and in vivo experiments. Proficient writing capabilities and computer skills as well as proper experimental design and the ability to implement new technologies are the keys to my success in academia and industry. Additionally, my problem-solving abilities, analytical acuity, efficient project management and the effective use of communication enable me to effectively tackle challenging independent and team-based projects.
My most recent employer, Chattem, Inc., is a marketer and manufacturer of branded OTC healthcare products in such categories as medicated skin care products, topical pain care, oral care, nighttime sleep-aids, sunscreens, medicated dandruff shampoos and dietary supplements. Despite Chattem’s relative small size (less than 500 employees), the company boasts a diverse portfolio of over 100 different products and annual revenue exceeding $450 million. Therefore, as a senior pharmacovigilance/regulatory affairs consultant, I had to be prepared for a diverse array of safety and regulatory issues ranging from development to post-marketing surveillance. Furthermore, I had to work quickly with multiple departments and areas within and outside the company. A few of my various pharmacovigilance and drug safety responsibilities include reviewing adverse event data, detection of safety signals, chairing the AE Committee Review meetings and providing non-clinical/clinical data analysis. Some of my responsibilities in the area of Regulatory Affairs include drug regulation and monograph interpretation, labeling/ingredient listing reviews, and claim support justification. These responsibilities required a significant amount time of writing technical documents such as New Drug Application (NDA) Periodic Safety Update Reports (PSURs), standard operating procedures (SOPs), promotional material for health professionals, FDA Medwatch 3500A forms and white papers. I was involved with multiple team based projects and the implementation of the customized versioning/coding of the InfoMed database was a notable project that I led.
As a postdoctoral fellow at the Johns Hopkins University School of Medicine, I undertook multiple research projects studying T cell activation and tolerance within the Division of Immunology & Hematopoiesis in the Department of Oncology. Prior to Hopkins, I was a graduate student in the Department of Veterinary & Biomedical Sciences at The Pennsylvania State University studying the roles of macrophages during inflammation and infection. By utilizing my expertise regarding in vitro assays (biochemical, immunological, cellular-based) and in vivo model systems, I have been able to discern the roles of various genes/pathways in T cell tolerance/activation as well as in disease models of cancer, autoimmunity and inflammation/infection. This background is tempered by work at Centocor within the Immunology and Pharmacology & Toxicology Departments in assisting the development of monoclonal antibody therapy to treat arthritis and other inflammatory diseases.