During my PhD, I believed that I would be a researcher forever. However, on completing my thesis I just couldn’t find the right job for me. Finally, after working at a small pharma company and then as a post-doc in stem cell biology, I decided enough was enough and accepted that bench research wasn’t going to give me the work–life balance, stability and opportunities for progression that I was looking for in a career.
I was aware of the medical writing industry, but I didn’t feel that MedComms was quite what I wanted to do. At this stage I didn’t realise that regulatory writing was an option, but as I explored further, it became apparent that it would suit me perfectly. Regulatory writing is much more structured than MedComms and involves working on both small and large documents to submit to regulatory authorities, rather than presentations or events. I also discovered that as a career it could provide me with the things that drew me to research in the first place: the opportunity to learn something new every day and to contribute in my own small way to the development of medicines that will improve patients’ lives.
Living in Kent, I was a little hesitant about applying to a regulatory writing company based 100 miles away in Oxford, but Certara Insight gave me the opportunity to work remotely. Regular virtual catch-ups with my colleagues, as well as a few visits to the office, quickly made me feel part of the team. When I started at Certara Insight, it was a steep learning curve, but working alongside more senior writers, as well as regular in-house and external training opportunities, meant that I gained experience in a wide variety of documents in a short period of time. I also began to appreciate that regulatory requirements don’t end when a drug is approved. Clients often want to develop their product for different indications or gain approval from different health authorities all around the world. In addition, the pharmacovigilance requirements continue throughout a product’s life cycle.
I have worked at Certara Insight for just over a year on a broad range of documents including investigator’s brochures, clinical study reports, protocols and risk management plans. What I particularly enjoy about the job is working for different clients who are developing products across a range of therapeutic areas. I get to interact with scientists and physicians who are global leaders in their field, and there is a real sense of achievement when a document is approved. While I am no expert yet, I feel that the skills I developed during my PhD have really helped me to thrive in this job and I’m excited to discover where a career in regulatory writing will take me.
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