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Kate Chiswell, MSc
Program Manager
Kate is a detail oriented medical communications professional with expertise in Early and Late Phase Clinical Development. She also leverages her analytical skills and problem solving skills in writing e-learning programs, developing medical curricula and presentations for key opinion leaders.
I didn’t want to just do one thing, it was important for me to try different types of writing and at the end of the day it’s made me a much better writer.
You won’t know what you enjoy if you don’t try different things.
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*The views and opinions expressed in this profile are those of the professional and do not necessarily reflect the official policies of their employer.
Tell us about your career path
It took me about a year to get my first job after completing MSc and it was really an exercise of persistence and taking advantage of your opportunities.
My first job was as a pharmacokinetic (PK) associate and the head of the PK department also happened to be in charge of medical writing.
Here, I started learning about pharmacokinetic analyses in clinical trials and I also began writing protocols and reports for clinical studies.
People were starting to understand the quality of the work I was doing and a headhunter reached out to me about a medical communications opportunity, which I was excited to try because it was different from what I had been doing. Now, I’m enjoying my currrent role, which has a more extensive focus on clinical research.
What sorts of experiences help aspiring medical writers stand out?
In my opinion, someone’s degree is not the be-all-end-all in terms of whether they can become a medical writer.
Unless you would like to be a medical director, I don’t believe that it’s mandatory to have a PhD. If you have an MSc as well as clinical experience, you’re not in an inferior position relative to another candidate that has a PhD but no clinical experience.
There are different focal points when it comes to medical writing. For example, if your primary focus is regulatory submissions, some experience in regulatory affairs will be important.
Conversely, if your focus is writing clinical trial protocols, knowledge about the clinical trial process is key.
What are the biggest challenges and rewards with medical writing?
The biggest reward is when a client is thrilled with your work and how the project went. On the other hand, a frequent challenge can arise when clients have difficulty communicating internally in order to make decisions.
I’ll often end up being the person that needs to take charge to ensure that decisions are made in a timely fashion to keep a project on track.
Another challenge is when a client has a study design in place but then wants to change it completely. As a result, it’s important to make these changes in a timely manner while still producing work that is of a professional standard.
How has COVID-19 impacted your work?
As you know, COVID-19 poses a big health risk and we now need to implement new safety measures for clinical trial protocols.
Studies have been on hold for months but sites are starting to reopen so that’s forced us to scramble to amend protocols. We'll have trials with healthy volunteers but we need to be very careful with volunteers coming in trial sites so they don’t infect everyone.
This has led to a set of unprecedented questions that we need to answer.
For example, what if a participant tests negative upon screening but positive after consuming the study drug? Do we record this as an adverse event to the drug or as a symptom of COVID-19 infection?
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