Specialization in Regulatory Medical Writing

Translate Clinical Data Into Clear Language


Program Details

  • Location: Online
  • Duration: 11 - 12 weeks
  • Times: Flexible, Evenings
  • Cost: $1,545

Next start date:

September 18, 2024

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Talk to an Enrollment Coach

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

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.

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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


Projected growth in U.S. demand for technical writing skills (2024–26)


Projected growth in U.S. demand for scientific writing skills (2024–26)

Source: Lightcast


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.

Learning Formats

Online Asynchronous

Enjoy the flexibility of asynchronous learning with the structure of a regular course. With no real-time meetings, you’ll complete weekly assignments and interact with your class at times that work for you. Learn More »

Online With Real-Time Meetings

Online With Real-Time Meetings

Combine the convenience of online learning with the immediacy of real-time interaction. You’ll meet with your instructor and classmates at scheduled times over Zoom. Learn More »

Program Sessions

Online Asynchronous

    This course is offered 100% online and runs from September 18, 2024, to December 11, 2024.


    Noncredit Program

    You'll earn 3.6 continuing education units (CEUs) for successfully completing this program. Learn more about noncredit options.

Online With Real-Time Meetings

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