Janeen Skutnik-Wilkinson Moderna

Janeen Skutnik-Wilkinson is the Director of Regulatory Surveillance and External Engagement at Moderna. She has spent the last 29 years in the pharmaceutical industry in a variety of roles in Document Management, Pharmacopoeial Affairs, Quality Systems, RegCMC and Regulatory Intelligence spanning several companies: Merck, Pfizer, NSF, Biogen and now Moderna. She has been involved in ICH since the late 1990s, sitting on 2 EWGs and currently sits on the ICH assembly, ICH QDG and the ICH M1 Ptc. She has held leadership roles in several trade associations including serving twice as the chair of IPEC americas and a past president of the IPEC Federation. She is actively involved in PDA, ISPE, IPEC, BIO, EUCOPE, EFPIA, Vaccines Europe and Biophorum. She holds a degree in Chemistry from the University of Connecticut.