Guest Article: Educational Options for Breaking into Regulatory Medical Writing

by Mitch Gordon*

I’ve seen this question asked fairly often on the medical writing forums: What kind of certificate or degree can I earn that will make me more employable? Writers, both new and experienced in another niche, are particularly interested now in regulatory writing. This is the kind of writing that US drug or medical device companies use to apply for FDA approval of their products. It is the most lucrative and sought-after branch of medical writing, but it is also difficult to break into.

Employers expect their regulatory writers to know clinical trial processes thoroughly. They also expect their writers to have detailed experience creating the documents that go into regulatory submissions. Typically, deadlines are tight and mistakes are costly in the drug and device industries, so there’s little tolerance or support for inexperienced writers. It’s not a setting where there are many opportunities to learn on the job.

Writers who want to work in the regulatory arena need to acquire the necessary knowledge somehow, of course. It’s natural that they would consider educational programs that will help qualify them for regulatory writing. And, in recent years, the number of educational programs related to regulatory and clinical affairs has been steadily growing. These programs educate not only writers, but many other professionals as well. After all, chemists, engineers, managers, biologists, and physicians need strong regulatory knowledge and credentials to establish themselves or advance in their industry.

What kinds of programs are available? What do they cost, and how long does it take to complete them? Are some credentials stronger than others in the eyes of employers, and are the stronger ones worth the extra cost? I can’t answer all of these questions definitively for you-you will have to do your own research.

However, I can give you a general idea of what’s out there. Most clinical and regulatory credential programs fall into three categories: (1) certificates offered by professional associations, (2) certificates through university extension, and (3) advanced degrees. Here are my thoughts on each of these categories.

Professional organization certificates: You can earn certificates related to regulatory and clinical affairs through the American Medical Writers Association (AMWA), Regulatory Affairs Professionals Society (RAPS), or the Drug Information Association (DIA). AMWA offers a Core Certificate in medical communications. It consists of 12 hours of general courses and 12 hours of specialty area classes, the latter of which can be on subjects related to pharmaceuticals. Additional course work can be applied to an Advanced Certificate. The benefits of AMWA certificates are that they are specific to medical writing, cover useful topics, and can be combined with networking at AMWA conferences. Those who want to transition into regulatory writing can use these courses to strengthen their other credentials. The down side is that they provide fairly limited knowledge of regulatory and clinical affairs, and may be perceived as weak credentials, compared with the more targeted certificates and degrees.

The DIA offers a Clinical Research Certificate that requires 41 hours of course work, primarily at 1- to 2-day training sessions, but also online for some courses. Their classes can be costly, especially when you factor in travel. However, taking them is a fairly quick way to acquire a certificate that indicates an understanding of clinical trials.

RAPS offers the Regulatory Affairs Certificate (RAC), which is considered a strong credential in the biopharmaceutical and medical device industries. It is awarded based on your taking an examination, so you do not necessarily need to take RAPS courses. One approach is to complete a Masters degree or university extension certificate in regulatory affairs, and then sit for the RAC exam. Note that there are other requirements for the RAC, such as working time in industry, so contact RAPS for specifics.

University extension program certificates: Several universities offer certificates in regulatory affairs or clinical research through their extension departments. These accredited programs are exclusively online, exclusively onsite, or, in some cases, you can choose between those options. If you are in a metropolitan area with an established biomedical industry, one of your local universities may offer this kind of program. Otherwise, an online program is a good option. There may be some entrance requirements, but these are less extensive than for degree programs, and the program can be completed in considerably less time than a masters degree. I’ve seen some programs requiring as few as 12 units of coursework, and others requiring twice that, so do the research to find out what’s best for you. Some institutions worth checking are the University of Georgia, University of Washington, and the University of California at Santa Cruz (regulatory and clinical) and at Berkeley (clinical only).

Masters degree programs: A handful of universities offer a Masters of Science in Regulatory Affairs, including San Diego State, Johns Hopkins, University of Washington, and University of Southern California. One school, University of the Sciences in Philadelphia, even has a masters program in Biomedical Writing. Several of these universities offer certificates as well as degrees, and the certificate classes will typically contribute towards the masters if you choose to continue in the program. Some of these programs are either exclusively online (San Diego State and USC), or they’re offered both online and onsite (Johns Hopkins).

You may have taken online courses in the past that failed to impress you. You may also wonder how good an education you’ll get if you pursue a masters degree online. I can speak from my own experience in the masters program at San Diego State (where I’m about a year away from completing my regulatory degree), but my answer is “pretty darned good.” While there is no face-to-face interaction, and the lectures are broadcast or downloaded, there is a great deal of communication with instructors and other students using email and the required discussion board participation. Most classes in my program require team projects where you collaborate with two or three students to develop a complex document like a regulatory strategic plan, a consent form, or a project schedule. It also helps that the instructors are mostly consultants from industry, and the students all have undergraduate degrees in the life sciences and, in many cases, plenty of industry experience.

So, is a certificate or a degree in regulatory affairs, clinical research, or biomedical writing right for you? It depends on your needs and circumstances. It takes a long time and considerable expense to complete one of these programs. Moreover, it can be hard to succeed with the training if you also have full-time job and/or family responsibilities. But, at the end of the process, you have a strong credential that shows you understand this complex field. While this qualification alone may not pave the way to career success as a regulatory writer, it should help open the doors to the hands-on work experience you will also need.
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*Republished with permission from the author. Originally published in Vol 2, No 20, of the The Biotech Ink Insider, a free medical writing career newsletter. Subscribe to the Insider!

 

About the Author

Mitch Gordon has been a professional writer for 16 years. He is completing his Masters degree in Regulatory Affairs, to be finished in early 2010. His specialties are regulatory and clinical documentation, and he writes a wide range of other documents that support life-sciences companies.

Mitch Gordon
Medical and Regulatory Writing
Website: http://www.mitchgordonwriter.com
Email: mitchgord@aol.com
Tel: 707-869-4561