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Regulatory Medical Writing

After completing the American Medical Writers Association (AMWA) Essential Skills Certificate program in August 2021, I decided to specialize in health/patient communication and regulatory affairs as a medical writer.


That's when I joined Regulatory Affairs Professional Society (RAPS), which allowed me to take the Regulatory Medical Writing bundle at a lower price. This program comprises the following courses:


  • Introductory Medical Writing

  • Intermediate Medical Writing — Investigational Applications

  • Intermediate Medical Writing — Pharmaceuticals and Biologics

  • Intermediate Medical Writing — Medical Devices


Last week, I completed this program six months after enrolling:



The truth is that I had already finished the first two courses in September. However, in that month, I fell when I was hiking and fractured my left arm.


Aside from taking time off to make a full recovery, I had to prioritize other learning opportunities, such as my Master's in Medical Translation, which I completed in November.



My goal as a medical writer specializing in regulatory affairs is to help prepare top-quality documents to request approval and marketing of health care products.


That is why I will continue investing in continuing professional development to hone and refine my skills.


I have some questions for you:


  • What learning opportunities have you already completed since 2022 began?

  • Is there anything you expect to finish before this month is over?

  • What other goals do you have for the remainder of the year?


Let me know in the comments below!

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2016–2023: Antoni Maroto

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