Medical, scientific & technical writing experience
Having been in the pharmaceutical and biotechnology industry for more than a decade as a Principal and Senior Medical, Scientific & Technical Writer, EU MDR 2017/745 Consultant, Subject Matter Expert (SME), team leader, manager, core team member representative of R&D and scientific researcher, Dr. Dennis Van Hoof, PhD, has a solid understanding of what it takes to bring medical drugs and diagnostic devices to the regulated market.
After 12 years of PhD and postdoctoral academic research in Molecular & Cellular Biology and Biochemical Physiology, during which he published more than 30 peer-reviewed articles in scientific journals (including Nature and Cell), and book chapters, he switched to the industry by joining a small startup company (ARMO Biosciences) that develops cancer drug treatments.
He continued his career as a manager at BD Biosciences, generating the documentation and supervising the R&D activities to commercialize platforms for the diagnosis of leukemia & lymphoma, and contributed to the market launch of numerous in vitro diagnostic (IVD) solutions.
He worked as a freelance Writer, during which he offered his black belt-level Microsoft Word user skills and writing expertise to medical & scientific consulting companies, such as Xelay Acumen and Stryker.
He then worked for Thermo Fisher as a Medical, Scientific & Technical Writer for their COVID-19 test kits and IVD devices.
From there on, he continued his Medical Writing skills at Contract Research Organizations (CROs), including Network Partners and ProPharma Group, to generate the documentation for bringing Medical Devices and In Vitro Diagnostic Devices as well as pharmaceutical drugs to both the USA and EU markets under FDA (510k) and Notified Body (EU MDR 2017-745 and IVDR 2017-746) regulations. Some of the companies he has written documents for include Johnson & Johnson, Boston Scientific, HutchMed, Integra, Merz, Imvax, Jazz Pharmaceuticals, Medicago, RegenX Bio, Microport Ortho, PGDx, Sentynl, and Tissium
He also offers consulting and training on clinical study design and guidance on clinical evaluations and interpretation of the EU MDR 2017/745 and MDCG documents.
