Colette O'Sullivan BSc, PhD

Medical Writer/Consultant

Background
I have more than 20 years' experience as a medical writer, in both the academic and healthcare sectors. My extensive academic background includes doctoral and post-doctoral clinical research experience in oncology (CRC Laboratories, Nottingham University; Dept of Pathology, John Radcliffe Hospital, University of Oxford). I have written several primary and review articles and my research has been published in leading journals such as the Lancet (see bibliography).

I have also worked as an academic peer reviewer for the Journal of Pathology, and as a medical editor for Oxford University Press. In 1994, I joined (Astra)Zeneca as a regulatory medical writer. While acquiring experience in many therapy areas, I progressed to Global Lead Regulatory Writer in oncology. This period in my career equipped me with a comprehensive understanding of drug development and a familiarisation with European, US and Japanese regulatory environments. I gained experience in many aspects of dossier preparation, including clinical study reports, high level clinical summaries, investigator brochures, and regulatory briefing and response documents. With the emergence of ICH guidelines, I spearheaded the development of the company’s guide to clinical trial reporting and was also responsible for training new writers.

Since founding Scriva Medical Communications, I have been able to draw on my wide range of writing experiences to offer a portfolio of services in both the regulatory and publishing arenas. My skills ensure a critical interpretation of scientific data and translation into meaningful messages.

A Medical Writing & Consultancy Service for the Healthcare Industry