A couple of months ago I received an email from a gentleman called Paul, from Georgia. He asked if I had any tips on getting into regulatory writing. Unfortunately I wasn’t able to be of much help to him since this is not an area of writing in which I work.


Regulatory Writing

Regulatory writing is a specific branch of medical writing, and as is often the case with other aspects of medical writing, it can be a difficult one to break into. Companies don’t typically want to hire writers without regulatory experience, yet at the same time, it’s tough to get the experience when nobody will hire you!

Recently, however, I came across an interesting thread on LinkedIn that I forwarded to Paul. It was in the group Medical Writers’ Forum”, and was started by Ellen Barosse, CEO of Synchrogenix, a large international regulatory writing firm.

She specifically discussed the problem of how many people want to be regulatory writers but they don’t know where to start.

One problem that she highlighted, however, is that frequently when she interviews candidates, she is surprised at how few actually set themselves up to increase the chances of being hired in the first place. She says that in order to maximize your chances of being hired, be sure to follow these basic points:

  • Understand what’s involved: You must like science, have good mathematics skills, know how to write well, and be able to sit at a computer for at least 8 hours each day. But you also need to be social enough to interact with colleagues and clients.
  • Have good computer skills: You need to be an expert in Windows (make sure you can efficiently manage files and folders, and that you know how to control where your documents end up when you save them) Word (make sure you know how to apply styles to paragraphs, and can paste from different source without corrupting the styles; that you can switch between portrait and landscape pages, insert cross-references, and handle a table of contents; that you have the necessary skills to make complex tables) and Excel (know how to use built-in functions such as sum, average, standard deviation) – practice makes perfect, so make sure you can work swiftly and correctly. And use a PC – Macs are not often used in the regulatory field.
  • Develop an understanding of language fundamentals and style-guide conventions: Know when to use commas, hyphens, and other punctuation. Study the AMA Manual of Style (in particular Sections 2,3, and 4) – most pharmaceutical companies have adopted modifications of this as their writing style.
  • Develop excellent proofreading and editing skills: Find proofreading and quality-control tests online. Regulatory writers often have to do quality control as part of their work, so you should practice these online tests over and over until you can catch every error.
  • Learn how to write well: Many writers swear by Strunk & White’s “The Elements of Style”. Practice writing for at least one hour each day. Get other writers to critique your work. Take as many opportunities as possible to write – for your local church or community group, local newspaper – any chance you can take! Write simply and clearly.


Ellen Barosse concluded these suggestions by noting how these can all be followed without much expense – online resources can be utilized, and don’t forget your local library for books. Pursuing as many of these options as possible will only further increase your chances of being hired, and will leave you better prepared to learn regulatory writing – when you are hired, you’ll be able to concentrate on learning the content of the profession rather than beginning to learn to use Windows and Excel effectively, etc., or learn AMA writing style.

Barosse mentioned that her company, Synchrogenix, has a new program to train a small number of inexperienced regulatory writers – they offer this program their in Nashville & Austin offices here in the US, and in Manchester, England too. 

So the future for writers wanting break into the regulatory field may be opening up! Be sure to check out these options if you’re looking to get into the regulatory writing field.


And Finally……

Another writer also left a comment on the thread, adding that anyone who wants to get into regulatory writing needs to produce a CV that is well-structured and correctly formatted – otherwise it’s unlikely that anyone will trust you with regulatory documents.

He noted that it’s also important for writers to know what they are getting into in this particular field of writing. Regulatory writing is not just about medical writing – but also about looking for relevant patterns in data, and recognizing what is important. So if you don’t enjoy statistics and data evaluation, or complex tables, the regulatory writing field may not be the career for you.

He reminded everyone of how important it is to have some awareness of the regulatory aspects of the pharmaceutical industry – simply having qualifications such as a medical degree or a PhD are not necessarily going to immediately qualify you for this branch of writing. Guidelines differ across different areas, such as veterinary products, human pharmaceuticals, and the medical device industry. They also differ across different geographical locations. So another piece of advice that he offers when applying for a job, is to be aware of what the specific company does – check what products it has, and the regulatory environment in which it operates.

I thought this was all great advice for budding regulatory writers, so in addition to forwarding the link to Paul who had originally emailed me, I decided to share it here for anyone looking to break into this field.


Image credit jannoon028@FreeDigitalPhotosl