I took the long route into regulatory writing. After an undergraduate degree specialising in pharmacology, I did a PhD in cell biology, and then fell into that trap laid by universities: the idea that continuing in academia is the only possible career choice. That is definitely not true, but I think that the experience of project management and awareness of scientific data and literature that I gained during my two subsequent post-docs were valuable when starting out in regulatory writing.
My first post-doc was my most productive time in the lab, but we couldn’t get funding for me to continue. Not long into my second post-doc at a different university, I could see no real change in my experience and I didn’t like the way that my career path was evolving. I felt that I had strengths that were ignored by colleagues, such as taking a systematic and meticulous approach to lab work and making suggestions to improve readability of manuscripts. I enjoyed teaching, and feedback from students of all levels told me I was good at explaining scientific and technical concepts. Perhaps I could better use these strengths in another career?
I had already heard of medical writing and had been to a MedComms careers event during my PhD. Since then, medical writing had stuck in my mind as a possible alternative career to research. As a post-doc, I started entering science writing competitions to try out different writing styles. At a careers fair, I took the opportunity to find every medical writing company exhibiting. Talking directly to the employers was valuable in discovering the characteristics and scope of each company. This way, I came across regulatory writing for the first time. I signed up for an open day held by Insight Medical Writing (now Certara Insight) to find out more. It seemed perfect for me, and I successfully applied for a medical writer position there.
That was over 5 years ago, and I haven’t looked back. I found a supportive and collaborative environment where I could apply skills I already had and learn new ones. My work has included all kinds of clinical, regulatory and pharmacovigilance documents, and even some website content. As part of my role as a medical writer, I am in contact with client project teams on a daily basis. As I have gained more experience, I have also had the opportunity to lead more complicated projects and to mentor new colleagues. A major positive of the job is that I am constantly learning about new and diverse fields of medicine. Quite the change from the narrow focus of academia!
I believe that anyone with a scientific background can become a regulatory writer. The big challenge is presenting large amounts of complex data in a clear and understandable way that is relevant to the purpose of each document. Experience of the pharmaceutical industry or specific documents isn’t necessary, and there is plenty of internal and external training on the job.
There’s a growing body of online resources to help you move into regulatory writing. I’d advise using them as a starting point to discover the best fit for you. I’m glad I found my way into regulatory writing, and I hope you will be too!
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