Kristen Drake, Director, Medical Writing, is a writer, editor, and project manager with over 30 years’ experience in pharmaceutical writing, including US and international regulatory and educational documents. She provides strategic planning, coordination, knowledge, and expertise to produce high-quality documents regarding scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes within established timelines.

Ms. Drake has written documents and managed projects for drugs, biologics, and medical devices. She has held senior writing positions at pharmaceutical companies, as well as at contract research organizations. Her therapeutic areas of expertise include CNS, psychiatry, oncology, dermatology, cardiology, GI, diabetes, pain, women’s health, and rare diseases. Her management experience includes direct reports with varying levels of experience, and responsibility for development, oversight, costing, and resourcing.

Ms. Drake earned an MS in Regulatory Affairs for drugs, biologics, and devices from Northeastern University, as well as a BA in English from Florida State University. In addition, she holds certificates in medical writing through the American Medical Writers Association.