regulatory writer chenToxicologist and Regulatory Writer Dr. Chen

Dr. Chen is a board-certified toxicologist with over 15 years of regulatory writing experience. She has worked at the pharmaceutical companies Bristol-Myers Squibb, Amgen, and Allergan. In her role as a drug-development team leader/member, she composed the nonclinical sections of Investigational New Drug Applications, Biologics License Applications, briefing documents, Investigator’s Brochures, and clinical protocols. As a project toxicologist, she produced numerous data-driven slide presentations impacting safety and regulatory strategy. As a nonclinical study director or study monitor, she wrote or edited countless toxicology protocols and reports. She has worked with both chemical entities and biologics, including immunotherapies. She has expertise in endocrine, cardiac, renal, and hepatic toxicology, as well as in the therapeutic areas of oncology, cardiovascular and infectious diseases, dermatology, urology, ophthalmology, and immunology. Her industry positions enabled her to interact with the FDA and EMA.

In addition to producing the aforementioned deliverables, Dr. Chen has composed a broad range of documents as a freelance writer. The documents include white papers and blog posts on regulatory changes impacting medical devices, continuing education modules and abstracts for physicians and pharmaceutical sales people, and cardiology manuscripts. She is a member of the American Medial Writers Association, Society of Toxicology, and the American College of Toxicology. Prior to working in industry, she conducted postdoctoral research in molecular endocrinology at the University of Pennsylvania School of Medicine and Dentistry. Her research investigated repression of hormone receptors implicated in resistance to thyroid hormone syndrome and acute myeloid leukemia. She obtained a doctorate in Toxicology from the University of Rochester School of Medicine and Dentistry, where she researched environmental estrogens, and a bachelor’s degree in Biology and Environmental Studies, double major, from the University of Pennsylvania.

Dr. Chen realized how much she enjoyed scientific writing when she preferred completing her postdoctoral research grant to conducting the research. She has continued to love writing and the investigation and learning associated with each new project. Dr. Chen is looking forward to helping clients translate ideas and data into polished documents.


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