In many parts of the world, today is Labour Day, so I took this opportunity to step back from the day-to-day of writing clinical documents and reading regulatory guidelines and consider how I came to do this kind of work, what kept me engaged for close to a decade and what I came to think about it along the way. I would love to know your story too!
To be completely honest, I became a medical writer by accident, because I enjoyed scientific writing, I had some years of solid experience with literature reviews and hands-on research in toxicology and nanomaterials for biomedical applications and was lucky enough to keep in contact with a former colleague from Academia, turner medical writer and soon thereafter turned (my) mentor. This happened on the cusp of the MDD to MDR transition and I got to learn both the old way and the new, stepping into this role at a time when people had more questions than answers and those in the industry were either very confused (”What do we have to do and where do we start?”) or naively relaxed (the ”We have plenty of time” mantra… and we all saw how that played out).
What turned a happy accident into an almost decade-long profession is three-pronged.
On the one hand, it is what makes people’s skin crawl when they hear the words ”regulatory requirements”, namely the complex nature of the work and what may seem like nitpicking, going through pages and pages with a powerful magnifying glass looking for those details that do not fit (or writing those pages expecting that someone on the other side will do the nitpicking). The intellectual pleasure I take from well-constructed arguments is rivalled by very few other things. Of course, the greater goal and the greater good of being a small cog in the machine that delivers safe devices to better the lives of patients and clinicians helps when I get to take stock of my work, but let’s be honest, how often do we actually think of that greater good when going through UFMEA documents or PSUR reports or answering queries from Notified Bodies? I’d bet less often than we like to admit. I confess, I take pleasure in going through UFMEA and PSUR docs and answering questions from Notified Bodies, though I have never said it out loud before. Is it just me?
On the other hand, the nature of the job requires that, beyond detailed knowledge of the regulatory documents, we do deep-dives into a broad range of clinical topics, which, especially when dealing with new clinical areas, is similar to going back to school. Oh, the pleasure of understanding a topic, of seeing the puzzle pieces slowly fall into place and then being able to incorporate all that knowledge in a structured way to construct the clinical story of a device, with the added benefit the I call this work and I get paid to do it!
Last but not least, the people I met along the way, as a constant reminder of the fact that, at the end of the day, we are all individuals (not just job titles), with interesting stories, diverse and sometimes surprising backgrounds, valuable insights and intriguing points of view about the industry and the work we do. I would be curious to know your story. What path brought you to this line of work? What made you stay? What is the one thing you have often thought about our profession, but never said out loud? What would you like to change about it?