Medical Writing for Every Audience

In her role as a regulatory affairs manager at the University of Chicago, Anu Bangaley is constantly jumping back and forth between dramatically different writing styles. One moment she’s drafting highly technical FDA applications. The next, she’s taking complex clinical information and translating it into consent forms clear enough for any patient to understand. “I switch my writing constantly,” she says. “Getting the language right is a key part to improving patient understanding, smoothing regulatory reviews, and keeping studies on track.”

Bangaley’s first steps in this direction happened during her master’s program in global health, where her thesis took her to Uganda to research cervical cancer prevention. Traveling village to village and visiting schools across the country, she collected data on HPV vaccination programs and discovered an interest in research that would go on to shape her career. “The whole experience in Uganda, from doing research to collecting all the data, was amazing,” she recalls.

After returning to the US, Bangaley took a position as a clinical research coordinator at Advocate Health. Though she was learning quickly on the job—handling recruitment, patient schedules, and serving as a liaison between sponsors and investigators—she felt she needed more formal training. “I wanted to hold my own with the researchers,” she says. “I looked everywhere for a program and when I discovered UChicago’s Clinical Trials Management certificate, which was offered at the time, I enrolled immediately.”

She found her calling in regulatory writing. The course she took addressed questions she’d been wrestling with as a coordinator during COVID staff shortages, such as audit preparation and regulatory submission protocols. One hands-on exercise involved filling out a sample single-patient IND application for the FDA. “We literally filled it out in class,” she says, “so when it came up when I was working, I knew exactly what to do.”

But beyond form proficiency, she discovered something about herself. She was drawn to work that required translating between technical and accessible language. She liked being the person who could make FDA requirements clear using regulatory writing’s direct style and then pivot to drafting consent forms in language patients could understand. Both the precision and the code-switching seemed like skills she wanted to build a career around.

Fortuitously, around that time, she spotted a regulatory affairs manager position at UChicago and applied. Her combination of coordinator experience and certificate training landed her the job.

Eager to deepen her expertise, Bangaley went on to complete the Regulatory Writing certificate (now part of the Medical Writing and Editing Training Certificate program) by adding the Regulatory Intelligence course, which covered advanced FDA applications for drugs, devices, and combination products. “The instructors are amazing,” she says. “They’re all industry experts with years of field experience giving live examples. It’s not like they’re teaching from historical data.”

Now in her fourth year on the Professional Development Certificate Programs Student Advisory Board, Bangaley helps prospective students with the same decisions she once faced. She takes part in webinars and networking events and draws on her firsthand experience to address their concerns about balancing coursework with professional responsibilities. “When you are committed to something, just finish it. That’s what I tell them. Make sure to apply the skills at your current work and be bold about noting the certificates on your resume and LinkedIn.”

She says many students she meets are working professionals—from research coordinators to technical writers—looking to sharpen their skills or pivot into regulatory and medical writing roles. “They often tell me they want to be more confident in writing and compliance. These programs really give them the structure to achieve that.”

Bangaley’s path through multiple certificates—as well as courses in Medical Writing and Editing—perfectly illustrates part of the reason UChicago consolidated its medical communications programs. The redesigned Medical Writing and Editing Training Certificate program now brings together what were previously separate credentials into a single framework with specialized concentrations in Patient Education, Healthcare Advertising, and Regulatory Writing and a microcertificate in Regulatory Writing. There are also standalone courses that can be taken outside the certificate program that focus skills in areas that are relevant to the field.

For Bangaley, all of these experiences point to the importance of skilled writing in regulatory work. The way an FDA application is framed shapes how reviewers understand a study, and the way a consent form is worded affects whether patients truly grasp what they are agreeing to. Despite new AI tools emerging in the field, she’s seen that regulatory work still demands human judgment. “Writing, editing, and reviewing are a big part of my day-to-day work,” she says. “Ultimately, this work is about patient safety, and that’s something that applies whether you’re drafting FDA applications, consent forms, or clinical protocols.”

* The Clinical Trials certificate is no longer offered and Regulatory Writing is now a microcertificate under the larger umbrella of the more comprehensive redesigned Medical Writing and Editing Training Certificate program.