Medical and Healthcare Writer
Nicola Donelan PhD

I received my PhD. from the Graduate School of Biomedical Sciences at the Icahn School of Medicine at Mt. Sinai in New York City.

After graduating from Mt. Sinai, I pursued a post-doctoral fellowship at the Tisch Multiple Sclerosis Research Center of New York.  Here, I investigated the suspected viral cause of multiple sclerosis and searched for biomarkers of disease activity. In this environment, I interacted directly with medical doctors daily who worked closely with the scientists at this center.

Then, I joined Vivaldi Biosciences Inc., a biotech company in New York, as one of five leading scientists developing live-attenuated influenza vaccines (LAIVs).  As a result, I gained experience in every step of the FDA IND process, from research and development to product development, manufacturing, quality assurance, and compliance.  Among other responsibilities, I authored and implemented standard operating procedures (SOPs), study reports, manufacturing deviation reports (MDRs), and laboratory investigational reports (LIRs).  I summarized protocols and results of released testing for FDA IND submission and initiation of human clinical studies for the LAIVs.

In the last ten years, I have focused on freelance medical science and healthcare writing, working with a wide range of pharmaceutical, biotech and healthcare companies, individual physicians, universities, and healthcare communication agencies.

Clients included AbbVie, AliveCor, Alphabio Group, American College of Healthcare Sciences, Bay Area Medical, the Drug Delivery Company, Harvard University Healthcare Science Center, Hematology Oncology of Indiana, Industry Drive, Innovation Communications, InteGen, Inventprise, Jack Morton Worldwide, J&J, the Kidney Cancer Association, the Lupus Research Alliance, Matrix Biomed, Memgem, N8 Medical, Ohio State University, Oncolys USA, Oxygen Rescue Care Centers of America, Peer Tech Bio, Precise Bioscience, Predictive Oncology, Protquoal, Sanofi, Symetria Recovery, TARIS Biomedical and the University of Tennessee.

I have assisted these clients in medical and healthcare writing projects – drafting and editing medical journal articles, finalizing regulatory submissions, developing product case studies, creating detailed conference reports, crafting engaging newsletters and website content, conducting industry trend studies, summarizing expert interviews, and producing persuasive investor presentations. Additionally, I have extensive experience in healthcare communication, creating clear and impactful content for patient education, medical marketing materials, and internal communications.

I am a member of the American Medical Writers Association (AMWA).

LinkedIn Profile:
https://www.linkedin.com/in/nicola-donelan-0a5499

My Blog:
Perspectives on Medical Writing

Reference and Work Samples:
References