Did you know that there are at least 6 types of medical writing?
One of the most technical of these writing roles, is regulatory medical writing.
Regulatory Medical Writers (MWs) work in regulatory affairs and prepare documents needed for the development of drugs or medical devices. These include clinical study reports, safety updates, application submission dossiers, and post-marketing documentation.
Regulatory MWs are experts in regulatory submissions and therefore play an essential part in achieving drug licencing and maintaining that licence, so pharma companies can continue to sell their products. They provide an essential service to the biopharma industry.
To learn more about what regulatory writers do, Judith Simon a regulatory MW at RQM+, a consulting firm that is focused on medical devices and diagnostics, provides insights into her role.
Specifically, Judith writes regulatory documents for medical devices. Here, she speaks about her day-to-day work life and provides some fantastic tips of how she broke into regulatory medical writing:
How did you break into regulatory medical writing?
Before medical writing I used to work in academia.
Thinking back to the years in academia brings happy memories and I am thankful for all the opportunities. I got to work on exciting projects with great mentors.
I guess I was lucky in that every lab I worked in, I was surrounded by lovely people. I even found my partner in my PhD research group.
I enjoyed academia and leaving it was not something I considered initially. But later there was a shift in my thinking during the third year of my postdoctoral research.
The lockdown happened and this gave time to reflect.
Academia is great, but also has its downsides (specifically the constant cycle of the pressure to publish and to find funding).
Earlier in my career I was not so bothered by the competition and work pressure, because I had so much enthusiasm to do the experiments. I was not feeling the same enthusiasm anymore, so what remained was just hard work. Therefore, growing further in academia didn’t feel right for me.
I also realized during the lockdown that I was tired of reading for years about the same topic. I thought it would be refreshing to have the opportunity to work on different topics in parallel, instead of specializing on one specific topic.
During the lockdown I got to experience what it is like to work from home. I imagined that remote would be something I would like to continue to do, as it would allow me to be at home for our dog and to have flexibility to work in the Netherlands every now and then to see my family.
Once I decided to leave academia, I felt a bit lost, because I knew I wanted something else, but did not know exactly what the next step would be.
For a long time, I was focused on the narrow but clear career path within academia, so I needed to be informed what options there were outside academia. I planned sessions with a career coach (Dr. Hannah Roberts) to define a role that would suit my natural talents.
From the sessions it became clear it had to be a role connected to science, with impact through application, with lots of variety, more team-based and a good work-life balance.
Also, I found it very helpful to reach out to others who transitioned from academia to industry. Their stories were inspiring and broadened my perspective. They mentioned roles to me that I was not so familiar with yet, including medical writer, which sounded interesting to me.
From there, I connected with and spoke to several medical writers via LinkedIn.
Everyone has been so kind and open to share about their roles. I also felt informed via the BB blog and to read about medical writing on LinkedIn
I became especially interested in regulatory medical writing after speaking with a regulatory MW through an informational interview, where I learned about writing reports for clinical studies. She kindly advised me on how to update my CV and LinkedIn profile to highlight skills that are important for medical writing.
Not much later I was approached by a recruiter from RQM+, a consulting firm that is focused on medical devices and diagnostics. And from there I got my first medical writing role!
What do you do in your current role as a regulatory medical writer?
Since April 2021 I have worked as a regulatory medical writer at RQM+. I am so glad I made the transition from academia to regulatory medical writing.
At RQM+, I support medical device companies in writing reports that are fit for regulatory authorities.
I’m part of the post market team. We support with writing reports for devices that are already on the market. This means that we design surveys for healthcare professionals and patients to collect data on medical devices. The survey results are then presented in a report and the medical device company uses the report for submission to regulatory authorities.
These report submissions are required on a regular basis, depending on the risk class of a device, to ensure that medical devices are safe, effective, user-friendly, evidence-based and relevant.
As mentioned, I was searching for a job with variety and RQM+ offers this, as it is possible to work on different devices and companies in parallel.
Variety is also created by the clear deadlines. This is something I appreciate after being in academia for some time. In research, there are always new questions coming up and therefore new experiments that could be added to a project. The projects could feel never ending. Now I’m happy that I can now close off projects, once the deadline is reached. This frees me to the next project.
I currently work remotely and although this environment seems isolating, the day-to-day work itself is more team-based compared with my previous academic work.
Although most of the report writing is done by me, reports cannot be completed without interactions with the biostatistician, internal reviewer and other team members.
We also need to interact with the client, which gives me experience in the consulting side of medical writing.
What advice would you have for anyone looking to break into regulatory medical writing?
If you are interested in medical writing, but not sure yet which type of medical writing interests you the most, I advise you to:
- Speak to writers from different fields. As mentioned, this really helped me to get an idea of the different types of medical writing work.
- Apply for the different types of roles that interest you. I applied for both medical communications and regulatory medical writing roles.
For both roles, you usually must do an assessment – a writing test. I noticed that I enjoyed the assessment for the regulatory medical writing role the most, so that helped me to focus on regulatory medical writing.
- Follow online seminars e.g., via AMWA, EMWA, and the BB blog. There are a lot of materials online where writers share about different writing activities and their experiences. I found this insightful.
- Update your CV and LinkedIn profile. I was surprised to discover how much LinkedIn is used in the private sector for job searching.
It is worthwhile to have a close look at your CV/resume and LinkedIn profile, e.g., is it clear that you are open for a new job? Are the relevant skills (writing, data analysis, team-based working, management, quick to learn etc) for medical writer roles highlighted?
If you are interested to learn more about transitioning to regulatory medical writing after reading this interview, please contact Judith on LinkedIn. She’ll be happy to answer any questions you may have.
Best of luck with your medical writing job search!