Many folks ask me what you must do to be a medical writer. I think a better question is this: What does it take to be a regulatory medical writer–who should you be? Because it isn’t just about what you do, it’s about who you are. And frankly, that’s a big deal. If you think about it, it’s a lot easier to change what you do than it is to change who you are.
So, I would put my thoughts on what it takes to be a medical writer into two groups: what you must do, and who you should be.
If you want some specifics about this, read on. First, the easier one–what you must do:
(1) Get some specific training, depending on where your gaps are. Look at the AMWA and DIA web sites; they offer many excellent courses, some online, that can help beef up your medical writing skills. There are courses, and even a few degree programs, available through colleges and universities that also train students for medical writing careers. If you have years of industry experience and knowledge to use as a foundation for a medical writing career, you may not need these courses, or you may want to use them to supplement knowledge you’ve already acquired through industry.
(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, clinical research, or, if possible, medical writing. It’s impossible to competently write about drug development if you don’t know how the processes work and how drug or device products 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 yourself and see how the processes–and people–come together to create an approved product that sick people need. There is no substitute for this valuable experience.
(3) For some aspiring medical writers, English is their second language. Their first priority should be to learn to write well in native English–for English language submissions, as with submissions that will be sent to the US Food and Drug Administration (FDA), companies insist on documents written in native American English voice. This issue is the most significant barrier to success in regulatory medical writing for anyone who doesn’t already write in fluent, correct native English.
(4) Two other requirements for regulatory writers are an in-depth knowledge of medical terminology and regulatory requirements. Having a strong understanding of both is critical to being a successful regulatory writer.
(5) A less-talked-about, but important, requirement is an intermediate-to-advanced knowledge 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 tricks with it or you’ll never get anything done. If you don’t understand Word’s styles, captions, pagination, and headings, you’re at a severe disadvantage. Regulatory writing is about complex documents with large tables, figures, pagination across volumes, and many other idiosyncrasies that require deep expertise with Word for the writer to survive and thrive. As an aside, it is often useful to have basic or intermediate expertise with Microsoft PowerPoint and Excel, too.
And here’s the part about who you should be:
(6) Regulatory writers should be able to work well in a team environment, since they work with many other professionals, such as physicians, clinical research associates, and biostatisticians. If you can’t get along well with others and be diplomatic when you are in review cycles, you won’t succeed. Treat your team members with sensitivity and kindness; they’re under stress, just as you are. If you have to prod them to get their review comments back to you, do it with respect. Figure out how to get the information that you need without being abrasive or short tempered.
(7) Use clear, careful communication. Regulatory writers have to update their teams and sometimes upper management on how things are going. It’s important to not overstate or understate the status of your document, but at the same time to accurately and promptly inform your colleagues about problems or obstacles. This clear communication should also be expressed in your writing. Crisp sentences that don’t go on for 4 or more lines will contribute to a better reading experience.
(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. This job requires being organized, tracking and following up on unresolved issues, and ensuring that your document reflects accurate information. The devil is in the details, and not getting the details right can hang you and your job. If you are a big-picture person (eg, someone who glosses over the fine points of a project) you probably aren’t suited for regulatory writing.
(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. But the pressure can be fierce for companies to present data that will lead to product approval. It is always a mistake to put information in a regulatory document that you know is false. Always. 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 to do the writing and/or walk away from the project and the people behind it.
(10) Medical writing can be a solitary pursuit. It’s you and that computer screen for many hours each day. Often, 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, and this means you need to be content when working by yourself. If you are the restless type or you’re very extroverted, you may not be happy with a regulatory writing career.
(11) Be able to work with grace under pressure. Regulatory writing is controlled through deadlines, and sometimes the deadlines can’t be moved. If tight timelines make you sweat, you may not want to get into medical writing. And you should be able to accept selected imperfections in your work. Regulatory writing is about details, but the writing may not always turn out to be the most aesthetic prose. The writer (and team) must often accept a less-than-ideal final document, when the deadlines require it.
(12) You should 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 need a major face-lift. This writing isn’t like creative writing, in which your creative juices can be freely expressed. It’s formulaic writing that takes time and can sometimes cause migraines. Yet each document must be written in conformance with legal requirements and so that the audience, usually regulatory authorities, can clearly understand 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 very good at it, don’t even think about doing regulatory writing. A regulatory writing career is not for you.
This list of things needed to be a competent regulatory medical writer can be somewhat daunting. However, all these things are truly important for most regulatory writers to be successful.
Even if you already have some of these prerequisites under your belt, think carefully before jumping into medical writing. It is a great career, and if you’re experienced, you can sometimes work at home. But it requires a certain kind of person to do good medical writing–someone with the right temperament, detail orientation, and command of specific technical information. If you are that kind of person and you’re motivated to get the skills you still need, I urge you to pursue your dream. It’s a fabulous way to make a living and a great lifestyle, if you love writing and medicine.
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