About this Program
Note: This program was previously titled Specialization in Medical Writing.
Regulatory writers play a key role in the drug approval process. They develop documents that are submitted to regulatory agencies to initiate clinical trials and gain marketing approval for drugs. These in-demand professionals use their data interpretation skills and technical communication expertise to translate clinical data into digestible content for their intended audience.
In this one-course specialization, we’ll focus primarily on the documents needed for regulatory approval of drugs by the U.S. Food and Drug Administration. You’ll study the format and content requirements of regulatory documents and write excerpts of documents for regulatory submission. You’ll learn how to read, interpret and summarize data from clinical trials in various therapeutic areas. Along the way, you’ll hone your writing skills for a variety of audiences, including regulatory agencies, medical professionals, patients and the public.
Designed For
Technical writers and medical or research professionals looking to break into the field of regulatory writing or broaden their knowledge of regulatory documents.
See Requirements
Admission Requirements
To apply, you must have ONE of the following:
- Two years of college, preferably in the sciences, plus two years of experience in the field of technical communication or completion of the UW Certificate in Professional Technical Writing
- Bachelor’s degree, preferably in the sciences, English or communications
Time Commitment
Including time in class, you should expect to spend about seven to nine hours each week on coursework.
English Proficiency
If English is not your native language, you should have advanced English skills to enroll. To see if you qualify, make sure you are at the C1 level on the CEFR self-assessment grid. To learn more, see English Language Proficiency Requirements – Noncredit Programs.
International Students
Because this offering is 100% online, no visa is required and international students are welcome to apply. For more information, see Admission Requirements for International Students.
Technology Requirements
You must have access to a computer, and we recommend a high-speed internet connection.
Earning the Certificate
You earn a certificate of completion by successfully completing all required courses. For more information, see Earning the Certificate.
▸ Explore More: Check out other programs for writers and editors.
Skills You’ll Gain
- Drug development and approval lifecycle
- Regulatory guidelines
- Regulatory documents
- Clinical data interpretation
- Scientific writing
- Technical writing
- Plain language writing
- Quality control review
- Project management
- Medical terminology
Get Real-World Experience
You’ll develop excerpts of the most common documents that regulatory writers work with to add to your professional portfolio.
EARN A DIGITAL BADGE
After successfully completing this program, you can claim a digital achievement badge that can be shared on LinkedIn and other social media sites. Learn more about digital badges.
Career Stats
13%
Projected growth in U.S. demand for technical writing skills (2025–27)
6%
Projected growth in U.S. demand for scientific writing skills (2025–27)
OUR ENROLLMENT COACHES ARE HERE TO HELP
Connect with an enrollment coach to learn more about this offering. Or if you need help finding the right certificate, specialization or course for you, reach out to explore your options.