By Martin Wall, STC Carolina member
September Mihaly is a medical writer for IQVIA (formerly QuintilesIMS). She works primarily on documents, summarizing findings from animal and human studies, to be submitted to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world for applications to market drugs. These are delivered electronically to the FDA and, if printed, might be millions of pages long.
MW: Please describe what shapes your technical writing as you practice medical writing.
SM: A medical writer in the pharmaceutical setting needs to have some knowledge of drug development. Knowing what the FDA requires helps to shape the final documents. It helps that the FDA has developed hundreds of “guidances” to describe what types of studies to run, how the statistics should be described, what defines adverse effects, and many other important concepts. There are also international guidelines for writing applications for other countries.
Many people, including the regulatory group, statisticians, and medical doctors work together over a period of months or even years to report on a single study. It takes important soft skills and several years of experience with many document types to be able to become a senior medical writer.
Medical writing is a good place for a “jack-of-all-trades.” It gives you a chance to learn a bit from several different fields, and the more you learn about statistics, study design, and pharmacokinetics, the more of a contribution you can make.
MW: What are some unique challenges that are faced by technical writers that practice medical writing?
SM: Medical writing is a good place for a “jack-of-all-trades.” With so many people on the team contributing to study results or summaries of summaries, you have a large well of resources to draw upon. It gives you a chance to learn a bit from several different fields, and the more you learn about statistics, study design, and pharmacokinetics, the more of a contribution you can make.
Being extroverted has been a plus for me, but I have observed that most writers tend to be introverted. Writers write, but they might not enjoy chairing meetings or managing a lot of different personalities. It’s very important that every voice counts and every voice gets heard in a given meeting. Working with people in different time zones can also be a challenge. Sometimes calls are very early in the morning or late in the evening. I was once on a call with people in 5 different time zones speaking in 2 different languages. An hour into the call, the translator dropped off. That was challenging!
Another important challenge facing people new to the field is the difficulty of breaking in. Years ago, medical writers started out editing and doing quality control (QC) reviews of other writers’ work. Much of the QC work has moved overseas, so there are fewer entry-level positions. At the same time, medical writers are making more of a contribution to the content. Most positions require an advanced scientific or medical degree, and it is less common to see new positions requiring only a Bachelor’s degree.
MW: Who is your audience and how does that affect the way that your writing addresses sophisticated concepts?
SM: On the medical side of things, you have to look very closely at the benefit/risk analysis. Every trial will be asking if the possible side effects are worth the cost of what the treatment does. Ultimately, that decision will be made by the regulatory agency you are submitting to.
MW: What kinds of templates do you use for medical writing? Tell us how your appendices work as well.
SM: FDA “guidances” are very clear on the content for nonclinical (animal) and clinical (human) study reports, and templates are readily available. There are also conventions for datasets. Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) clearly describe the structure, variable names, and other naming conventions for pharmaceutical data. Some other document types, such as scientific papers and ad hoc reports will have more flexibility. Nonetheless, there is no need to reinvent any of these. If it was done before, even once, you can generally find a good starting point.
Appendices are generally compiled by the publishing group working together with Biostats. The process is more automated, but we will communicate about what will be included and if any of the tables are unclear.
MW: How do changes in FDA regulations over time affect your work?
SM: It is important to keep up with changes to FDA and international requirements. You can learn from going to FDA.gov and ICH.org searching. Other resources include American Medical Writers Association (AMWA), North Carolina Regulatory Affairs Forum (NC-RAF), Fiercebiotech.com, and Fiercepharma.com.
MW: Have you noticed any special relationship between regulatory medical writing and any other branches of technical writing (including other forms of medical writing)?
SM: As a regulatory writer, so much of what we do is focused specifically on clinical study reports. Other medical writers might work on scientific papers, continuing education for medical professionals, training for pharmaceutical sales reps and medical reporting (including blogs). One thing we all have in common is an enthusiasm for writing and learning something new.