Ann Winter-Vann joins Med Communications as head of our new Regulatory Writing department
Med Communications has added a new department: Regulatory Writing. This department will support clients’ regulatory needs by providing high-quality writing, project management, and consulting for projects like clinical study reports and full submissions. Leading this team is our newest director, Ann Winter-Vann.
Ann received her PhD in Molecular Cancer Biology from Duke University, where she was supported by a fellowship from the Howard Hughes Medical Institute. Following a postdoc with the Department of Pharmacology at the University of North Carolina at Chapel Hill, Ann transitioned into regulatory writing, where she supported a variety of clients that ranged from biotech start-ups to several of the largest pharmaceutical companies. Ann’s therapeutic areas of expertise include oncology (including CAR-T), gastroenterology, ophthalmology, respiratory, immunology, and rare disease.
With more than 17 years of experience in regulatory writing, Ann has authored clinical research and regulatory documents for the US Food and Drug Administration, the European Medicines Agency, and submissions to China. Her document experience includes protocols, clinical study reports, submission documents (clinical summaries, integrated summaries, clinical overviews, assessment aids, and responses to agency questions), Investigator’s Brochures, and briefing packages, and she is an advocate for lean writing principles. In her previous position as Director of Medical Writing Services at Whitsell Innovations, Inc., Ann led a department of 50 managers, medical writers, quality control reviewers, and publishers.
In 2021, Ann received the DIA Medical Affairs and Scientific Communications Excellence in Service Award. Ann is a Fellow and Past President of the American Medical Writers Association.
Med Communications is grateful to have someone with Ann’s background and expertise helping to establish this exciting new service area. We are confident that she will build a team that upholds Med Communications’ high standards for quality service and customer connection. Contact her today at 877-202-3759 or https://medcommunications.com/contact-us/.
