I came to regulatory medical writing in 2018, after finishing my PhD at the University of Birmingham, where I worked on the molecular biology of the papillomavirus life cycle and virus-driven carcinogenesis. Although I had an extremely positive PhD, surrounded by a great team, and thoroughly enjoyed my time in the lab, I had no interest in pursuing an academic career. I loved what I consider the ‘communication’ parts of my PhD – talking with biotechnology and pharmaceutical company reps, discussing science at conferences and teaching undergraduate students. I also thoroughly enjoyed contributing to book chapters, publications and teaching material.

Outside of my PhD, I worked as a freelance writer focusing on the preparation of medicolegal reports for expert witnesses dealing with personal injury, clinical negligence and criminal cases. Knowing that I didn’t want to be an academic, I started to look at alternative career options and a former lab member and current colleague told me about medical writing. I thought it sounded like something I would be interested in and so I attended a networking event run by Peter Llewellyn of NetworkPharma.

I didn’t know much about medical writing, never mind regulatory medical writing, when I went to the networking event. I learnt that regulatory medical writers work for a variety of companies and produce the documentation required by regulatory authorities to assess the safety and efficacy of drugs and medical devices. These documents cover the entire development process, ranging from clinical trial documents to applications for new marketing authorisations and post-marketing safety documents, and must be prepared in line with applicable guidance from regulators. This rather structured approach to writing appealed to me due to my background in medicolegal writing, which must also align to applicable codes of practice and numerous legal obligations as well as the preference(s) of the instructing party.

After some thought, and discussing the job with both management and medical writers at Insight Medical Writing (now Certara Insight), I took the plunge and forwarded my CV. Following an interview and some skills-based tests, I was offered and accepted a position as a medical writer.

I have been working at Certara Insight for almost 4 years now and have prepared a wide variety of documents, ranging from those in medical information, drug safety and risk management to applications for new marketing authorisations. I have also worked in diverse therapeutic areas, including oncology, neuroscience, respiratory, virology and rare diseases.

The most enjoyable part of the job is the sheer variety of documents that I have had the chance to work on. The opportunity to constantly learn and contribute to either getting a product to market or ensuring the safety of marketed products means I can satisfy my scientific curiosity without despairing over the thought of running yet another western blot.


This personal profile first appeared in the FirstMedCommsJob careers guide, A writer’s role in drug development: a guide to getting started in regulatory medical writing, published August 2022

One thought on “Paul McCormack, Senior Regulatory Writer, Certara Insight

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