Dr. Baldwin is a Primary Reviewer in the Office of Vaccines Research and Review (OVRR) at the FDA. In addition to her review activities, Dr. Baldwin has become the leading expert in OVRR on the use of clinical study standardized data. Dr. Baldwin’s involvement with CDISC began in 2009. In 2014, she helped in the development of a Vaccine Therapeutic Area User Guide (TAUG) and in 2018 contributed to the Clostridium difficile Associated Diarrhea TAUG. Dr. Baldwin has led and coordinated the development of and continued revision of an FDA technical specifications guidance, “Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review”, which was initially published in 2018.