Can Anyone Be a Regulatory Writer?

Knowing that regulatory writing is one of the best-paid venues in medical writing, some people have asked me how to break into this industry. But I always tell them that regulatory writing is not for everyone.

First, you must consider your background. Most regulatory writing positions at pharmaceutical and biotechnology companies require that you have an advanced degree (MD or PhD); some prefer or require experience in a particular therapeutic area. There are exceptions of course, and some CROs may give junior writers opportunities at regulatory writing.

“Our experience is that you need to be a good scientist first, preferably with a degree in the health sciences (pharmacist, pharmacologist, nurse) and then hopefully have a talent for writing,” says Larry Liberti, an experienced regulatory writer at Thomson Scientific. “The latter can be developed but it is rare to be able to train someone in the health sciences on the job.”

Second, you must be detail-oriented and be comfortable working with set guidelines and forms. If you are the creative type who likes to inject some art into your writing, well, you may want to try something else.

As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH.

If the above doesn't appeal to you, there are other venues you can try, such as consumer health writing or even developing Continuing Medical Education materials.

Thanks for reading!