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(2) To write about drug, biologic, or medical device product development as a regulatory medical writer, you need at least a few years of first-hand experience working in biotech, pharmaceutical, or medical device companies. Get a job in laboratory research, in clinical research, or, if possible, in medical writing. It’s impossible to competently write about drug development if you don’t know how the processes work and how drugs or devices are developed. In other words, you can’t write about it if you don’t understand it. And no, you can’t really understand drug/device development by reading about it in a book or on the internet. You need to experience it and see how the processes–and people–come together to create an FDA-approved product that sick people need.

(3) For some aspiring medical writers, English is their second or third language; their first priority should be to write in native English–for FDA submissions, companies have to have native English documents. I would say this is the most significant barrier to success in regulatory medical writing for anyone who doesn’t write in native English.

(4) Two other clear requirements are in-depth knowledge of (1) medical terminology and meanings, and (2) the regulatory requirements–first and foremost, the ICH guidelines. Having a strong understanding of both of these is critical to being a successful regulatory writer.

(5) A lesser requirement, but one that is nevertheless important, is an intermediate to advanced knowledge and understanding of Microsoft Word. You live with it, eat with it, even sleep with it as a medical writer, and you have to know how to do the “tricks” with it or you’ll never get anything done. Regulatory writing is about complex documents with tables, figures, pagination across volumes, and many other idiosyncrasies that require deep expertise with Word to survive and thrive.

And here’s the part about who you should be:

(6) Regulatory writers have to be able to work well in a team environment, since they work with physicians, CRAs, data management, and biostatistics folks. If you can’t get along well with others and be diplomatic when you are in review cycles, you won’t succeed as a regulatory writer. Treat your team members with respect, consideration, and kindness.

(7) Use clear, careful communication. Regulatory writers have to update their teams and management on how things are going. It’s important to not overstate or understate the status of the document you’re working on, but at the same time informing your colleagues about problems or obstacles that prevent the work from getting done well. And this clear communication should also be expressed in your writing. Clear, crisp sentences that don’t go on for 4 or more lines will contribute to a better experience for the reader.

(8) Regulatory writing requires focus and attention to detail. I don’t mean just a little attention, either–I mean insane attention to detail. In regulatory documents, consistency in language is hugely important; small inconsistencies can have big, negative consequences if they aren’t caught. If you are a big-picture type of person, someone who glosses over the fine points of a how-to project, you probably won’t be a good regulatory writer. The devil is in the details, and not getting the details right can hang you and your job.

(9) You must write with integrity. Drug development is a difficult business at best, and laboratory data coming from research projects are rarely clean and unambiguous. The same is true for clinical research data. It is always a mistake to write in a regulatory document what you know to not be true. If you are asked to write about data that you know was fudged, doctored, or misrepresented in the text, tables, or figures, my advice is to refuse and/or walk away from the project.

(10) Medical writing can be a solitary pursuit much of the time. It’s you and that computer screen for many hours each day, and you have limited contact with others while you’re cranking away. Most medical writers are introverts, and there’s a reason for this. You need quiet time and space to do your work, but this means you need to be able to be content working by yourself. If you are the restless type or overly extroverted, you may not be happy with a writing career.

(11) Be sure you work well under intense pressure. Many deadlines feed into the development of regulatory documents, and sometimes the deadlines can’t be moved. The regulatory writer must be able to handle time pressures with grace and confidence. If deadlines make you sweat big-time, regulatory medical writing may not be for you.

(12) You need to enjoy writing, and you should be a good writer. This sounds obvious, but it’s a serious consideration. As a regulatory writer, you will deal with drafts that are well written or, more often, drafts that require a major facelift. The writing isn’t like creative writing, where your expressive juices can run free. It’s formulaic writing that takes time and can sometimes cause headaches. Yet each document must be written in conformance with legal requirements and in such a way that the audience, usually regulatory authorities, can clearly understand the research and results–the story of the drug–that the document tells. This kind of writing requires patience, knowledge, and perseverance. If you don’t really enjoy writing or aren’t good at it, don’t even think about doing regulatory writing as a career.

This list of things needed to be a competent regulatory medical writer is likely to be daunting, depending on where you are in your career. However, I do believe that all these things are needed before most regulatory writers will succeed in their careers.

Think carefully before jumping into medical writing, even if you already have some of the prerequisites under your belt. It is true that it’s a good career, you can work at home in some cases, and if you enjoy writing (as I do), I highly recommend it. But it takes a certain kind of person to do good medical writing. You need a certain bank of specific information to work with, including regulations and medical knowledge, as well as an understanding of biotech or pharmaceutical products and how they are created and brought to market. And more than that, it takes a certain kind of person to put it all together with that knowledge, as outlined above.

If you are that kind of person, and have the motivation to get the knowledge for a medical writing career, I encourage you to pursue your dream. It’s a fabulous way to make a living and a great way to live.

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