Medical Writing Paths: ‘Medical Communications’ & ‘Regulatory Writing’

Barbara Grossman has a passion for proofreading, quality control, and education. She started Hawkeye Medical Limited, a medical writing and consultancy business, after working for a medical publishing company and then a contract research organisation, where she built up and managed its medical writing group. Barbara runs professional development training for companies and educational institutions. She has had many roles in the European Medical Writers Association (EMWA): workshop leader since 2001, Treasurer 1998–2005, member of the Education Committee 2010–2018, Education Officer 2014–2016. She was awarded an EMWA fellowship in 2005 and was EMWA President for 1 year until May 2020. In addition, Barbara is an Associate Editor of Medical Writing, EMWA’s journal.

Andrea has more than 30 years of experience in clinical research and physician relations. Author of more than 400 publications and articles, including more than 70 in peer-reviewed journals. He is past president, workshop leader, chairman of the study group on scientific communication and artificial intelligence, chair of the Italian group, and ambassador for the European Medical Writers Association (EMWA), of which he was president. In addition to his professional activities and training in medical schools, research centers, and medical-scientific societies, he acts as a speaker and chairman at several conferences.

Phillip Leventhal, PhD is a Manager of Medical Writing and Healthcare Communications at Evidera-PPD, where he specialises in scientific writing. He has nearly 20 years’ experience as a medical writer, has written and edited hundreds of peer-reviewed articles, and has worked extensively with, and trained, non-native English speakers in scientific writing. From 2012–2020, Phil was the Editor-in-Chief of the journal Medical Writing, and since 2010, has led professional workshops and academic courses on scientific writing throughout Europe and North America.

Monica Milani has been a medical writer since 2011. She began her career in a medical writing company, and then moved to the pharmaceutical industry. She has experience in a wide range of regulatory and medical communication documents covering various therapeutic areas. Prior to medical writing, she worked in academia and authored numerous articles in the immunology and oncology fields. She was editor‑in‑chief of the open access journal Drug Target Insights from 2008 to 2011 and served as a reviewer for several peer-reviewed journals. She is also an active member of the European Medical Writers Association (EMWA). Monica holds degrees in biological sciences, biotechnology and scientific/technical communication.

Sam Hamilton is a postdoctoral virologist with 30 years in clinical and regulatory medical writing roles, including leadership positions, in the pharmaceutical industry. Sam is an expert in writing and managing clinical-regulatory documentation for medicines licensing, and am international speaker in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the May 2016 open-access www.core-reference.org. Sam is long-time supporter of her professional association, the European Medical Writers Association (EMWA) www.emwa.org serving in various roles over 18 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW) (journal); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of the Executive Committee (EC). Sam was elected an EMWA Fellow in 2018 for her services to EMWA and the global MW community. Currently, Sam is MEW Section Editor for the “Regulatory Public Disclosure” Section, a Workshop Leader, and serves on the EMWA Regulatory Special Interest Group.