Sr. Medical Writer and Associate Manager
Stephanie Knighten joined Whitsell Innovations (WI) in 2015 as a Medical Writer. Ms. Knighten currently leads WI’s team of writers that specialize in clinical evaluation reports and medical device submissions for the European Union and the US Food and Drug Administration, which includes clinical evaluations that conform to the European Union Medical Device Regulation (EU MDR) and the European Medical Device Vigilance System (MEDDEV) 2.7/1, Rev. 4. In addition, Ms. Knighten and her team author clinical evaluation plans, systematic literature review plans and reports, state of the art literature review plans and reports, and post-market clinical follow-up reports. Ms. Knighten also consults on nonclinical regulatory authoring and submissions.
Prior to joining WI, Ms. Knighten was a freelance medical writer. Ms. Knighten wrote, reviewed, and compiled high quality technical/study reports, clinical study reports, benefit-risk assessments, clinical and nonclinical regulatory reports, white papers, Investigator Brochures, and other governmental submission documents. She also gained experience as a toxicology medical writer and study director before becoming a freelance medical writer. Ms. Knighten’s therapeutic areas of experience include drug delivery systems, influenza, medical devices, nutritional supplements and vitamins, ophthalmology, pain relief, respiratory, rheumatology, toxicology, and urology.
Ms. Knighten has a Bachelor of Science in Chemistry from the College of William and Mary and a Master of Science in Forensic Science from the University of Illinois at Chicago. She is a member of the American Medical Writers Association (AMWA).
In her spare time, Stephanie enjoys managing a full house and spending time on the soccer fields and in the swimming pool.