Regulatory Writing Certificate

Gain in-demand medical writing skills that will help elevate your career in medical communications with our certificate in regulatory writing.

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The Medical Writing Market is Strong. Make Sure Your Skills Are, Too.

Broaden your medical writing and editing expertise with UChicago’s Regulatory Writing certificate. This online program with synchronous sessions offers a comprehensive curriculum covering everything from writing documents such as informed consent forms, to collaborating on creating biomedical regulatory packets, to navigating the submission and audit processes for the FDA. The program consists of two courses and can be completed in as little as seven weeks, part-time.

Designed For

Designed for those with backgrounds in the healthcare industry or technical writing who are interested in regulatory writing training.

What Do Regulatory Writing Students Learn?

Participants learn how to:

  • Identify, edit, and contribute components of a biomedical regulatory packet 
  • Navigate the FDA submission and auditing process 
  • Prepare investigational new drug applications
  • Create submissions for different categories of biomedical research including vaccines, devices, and other categories

Valuable Teaching for Evolving Writing Professionals

Dive into the future of healthcare communication with our Regulatory Writing certificate program at UChicago. Led by industry pioneers actively shaping regulations and ethics, this course isn't just about learning—it's a doorway to the heart of healthcare communication evolution. Discover insights from leaders crafting today's regulations and paving the way for the writers of tomorrow. Join us in rewriting the narrative of healthcare communication.


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Career Potential

The regulatory landscape changes everyday, meaning agencies like the NIH and FDA have an ever increasing need for writers who can clearly and ethically communicate complex medical topics and navigate multi-phase submission processes. The Regulatory Writing certificate deploys inside knowledge and experience of the process, increasing your chances to build your writing career quickly.

50 %

The rapidly changing regulatory landscape demands highly skilled medical writers. Data published by Kolabtree in March 2021 stated a 50% rise in demand for freelance medical writers during the coronavirus pandemic and is only expected to grow.

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Write Your Future Today

With an instructional team of medical writing experts, our program teaches you what you need for career advancement—today.

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A Built-in Extensive Network

Accelerate your career with an extensive alumni community.

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Flexible Formats, Competitive Costs

Affordable part-time courses that work around your schedule.

University of Chicago Approach to Online Learning

Our online learning programs are crafted with your specific needs in mind. Live, interactive sessions strengthen your skill set, coupling rigorous theory and the latest research with real-world applications. You will have the opportunity to grow your professional network among University of Chicago instructors and classmates.

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