biographies

Kristin has 25 years of experience in the pharmaceutical and biotech industry. As the former head and Vice President of Medical Writing; Clinical Data and Document Services at Genzyme Corporation, Kristin developed and managed a team of up to 30 internal and 35 external staff for several years. 

Kristin has directly authored or

supervised the writing of countless regulatory documents in a wide range of therapeutic areas including orphan

diseases, enzyme replacement therapies, oncology, cardiovascular, Alzheimer’s disease, muscular dystrophy, HIV,

transplant, osteoporosis, and imaging agents. Kristin has written for and/or led the medical writing of more than a

dozen successful marketing applications. In addition to medical writing, she has expertise in training, best

practices, project management, structured content authoring, CDISC standards, electronic submissions, and QC.

Kristin is located in Kill Devil Hills, NC.

Kate is a dedicated and enthusiastic professional with over 25 years of experience in the biomedical sciences and pharmaceutical industry. 

As the former Director of Medical Writing at Genzyme Corporation and Sarepta Therapeutics, Kate is skilled at authoring/supervising the writing of protocols, IBs, CSRs, briefing documents, presentations, journal articles, white papers, and CTD modules (clinical efficacy, safety, and clinical overviews) for BLAs and NDAs in various therapeutic areas including depression, bipolar disorder, Parkinson's disease, Pompe's disease, muscular dystrophy, multiple sclerosis, oncology, cystic fibrosis, and hypercholesterolemia. 

Kate also has considerable expertise in project management and enjoys training medical writers and project teams in best practices for the development and review of effective regulatory documents.

Kate is located in Richmond, VA.