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.

Copyright 2013-2015  Biotech Ink, LLC. All rights reserved.

23 responses »

  1. I needed to compose you the very small observation to say thank you yet again for all the spectacular suggestions you have contributed in this case. It’s so unbelievably generous of people like you to offer unreservedly just what a few individuals could have made available as an e book to earn some profit for themselves, primarily given that you might have tried it if you ever wanted. The techniques as well served to be the good way to fully grasp other people online have a similar zeal like my own to see very much more related to this condition. I know there are some more fun situations ahead for folks who check out your blog.

  2. Sarah Murphy says:

    This blog is fascinating and really helpful. I am considering Medical Writing as a career and I would appreciate speaking to you for advice!

  3. Sarah Paik says:

    Thank you so much for this! I am planning to apply to pharmacy school within the next two years, and I know that I want to pursue a career in medical writing. I was just wondering if you had any suggestions about what I can do to prepare for pharmacy school and pharmaceutical writing during these next few years. Thank you again!

    • Sarah,

      Glad to hear you’re looking ahead! If you read my article on this topic, you know you need industry experience. Having the pharmacy school education will be helpful, but so would a few years in the biopharmaceutical industry. If you worked as a lab tech, regulatory affairs associate, quality associate, or other starting position, you might find your career going down a different path that doesn’t include pharmacy school after all.

      And, if you are intent on going to pharmacy school, but you want to be a regulatory writer, I suggest you get a PharmD. The reason is because competition can make getting hired as a regulatory writer difficult, especially since many MWs have a PhD, MD, PharmD, DVM, DDS, or other doctorate-level medical science degree. Competing against those guys with a bachelor’s degree will be hard, although not impossible.

      Let me know if you have other questions. Plotting one’s career course toward a medical writing career deserves thought and deliberate decisions, and I applaud your willingness to do this, even before pharmacy school.

      Best regards,

      Susan

  4. Victoria Ordronneau says:

    Hi Susan,
    Just stumbled upon your blog as I sat down to prepare for an interview tomorrow for a regulatory medical writing position. Thank you so much for your outstanding insights! I’ve worked as a medical writer in CROs for several years, but that’s been over a 20 year period, and my last gig was almost 5 years ago, so I feel rusty and a bit anxious.
    I plan to go through your other posts today, but I just wanted to let you know how grateful I am to have discovered this blog.
    Victoria

  5. Jean Williams says:

    I would like to know your thoughts on how to obtain information on medical writing on the patient education end of things. Is that side less lucrative, more competitive, easier to get into? I have a bachelor’s degree and have been writing about dentistry for three years–for a dental professional audience. I write for a newspaper so the articles are written in a manner that is comprehensible even to lay people. I enjoy writing about medicine and science, and I’ve considered obtaining certificates to avail myself to other opportunities in medical writing. Honestly, from what I’ve seen you spell out here about the regulatory side, that may be not my speed–though I’m not completely sure.

    • Jean,

      Suggest you find other blogs that more directly address medical writing from the patient education perspective. Because I’ve never done that type of medical writing, I’m not an expert and don’t feel comfortable trying to advise you on that type of career.

      Best,

      Susan

  6. Yogesh Gavali says:

    Mam, I have done MBBS, MD (Medical Physiology) and now working as an academic in medical college. I am interested to pursue career as Medical Writer along with my current job. Would you please guide me how to start for the same?
    Thanks.

    • Yogesh,

      Please read my blog article, What It Takes to Be a Medical Writer. It describes what you need to DO and who you need to BE in order to make a successful career out of medical writing. It has the best advice on the subject that I can give you.

      Best regards,

      Susan

  7. Barbara Hodgson says:

    Dr. Caldwell:

    I am a former attorney and environmental regulatory professional considering a change in career. I love the writing aspects of my job and have a B.S. in Entomology. I have a proficiency for medical terminology and concepts. I’ve checked out the Certificate programs available through DIA and AMWA. Is it possible to get a job as a medical writer after completing such certificate programs? I don’t want to waste my time and money if this is not a path that will lead me to some sort of compensation.

    Thank you,

    Barbara

    • Barbara,

      Certainly, it’s possible to do medical writing with such a background–you have a great education with some science-based work experience. However, you haven’t said what kind of writing you want to target. Regulatory writing has a particularly difficult path, because of the industry experience that’s pretty much a requirement for doing the job. Journalism, marketing, and manuscript writing are other areas that have their own requirements and hurdles. I think you first need to figure out what kind of medical writing you want to do, and then decide what the best path is to get the credentials needed for the job. Then you’ll have a basis for deciding whether the work to get started will be worth the compensation you would get down the road.

      Best wishes for success,

      Susan

  8. Anushi says:

    Hi Susan,

    This is extremely helpful. I have a PhD in Physiology and over 7 years experience as a Clinical Research Associate in the CRO and Pharmaceutical industry. Currently I work as a Senior Clinical Research Associate in Melboune, Australia. My career goal is to become a Medical Writer. I however can’t seem to find any opportunities for trainee medical writers. Please could you advice me on how to move in to this field with my experience?

    • Hi, Anushi,

      Many medical writers come from a CRA (and CRO!) background. I have not seen many trainee positions for MWs, although some of the mid-size to large companies offer internships, sometimes in the summers. To truly get on the right track, you need to get work as a medical writer, which means your resume must show what you’ve already done that qualifies you. Revise your resume as for medical writing, rather than for a CRA position. In each position you’ve been in, feature a description of your writing activities and what your contributions were (eg, clinical study protocols). Having a track record of already writing clinical documents will put you in the right path, and then apply to companies that are looking for Medical Writer I positions. With your PhD, I think you should be able to get a position in MW fairly easily.

      All the best,

      Susan

  9. Allison W. says:

    Dr. Caldwell:

    I have recently started a career as a certified medical coder. I love my job but I believe I would have enjoyed a career in medical writing as I find medicine interesting, particularly research. I believe I have a natural talent for writing that could be cultivated for this type of career. Sadly, I do not have a bachelor’s degree and do not have the resources or time to obtain one. I do have an Associate’s degree with focus on Microsoft Word and medical terminology/transcription. I believe my main lack of qualification would be my level of understanding of chemistry and my lack of experience with the required format/structure for these types of documents. Could I be qualified without a bachelor’s degree under these circumstances if I take classes to supplement these areas?

    • Hi, Allison,

      Thanks for getting in touch. The bad news is that almost all regulatory medical writer job descriptions that I’ve seen (online and in my job in various companies) require at least a bachelor’s degree, and often a doctorate degree in a life or medical science is strongly preferred. However, the good news is that you could possibly get into the field by targeting a medical writing assistant or associate position, because the academic requirements aren’t as stringent. Additionally, you might not necessarily need the industry experience up front that is pretty much necessary for regulatory and clinical medical writers. So I would consider seeking out such positions, and see if that path leads to something promising. Right now, the medical writing field is on fire, so it’s a good time to explore your options!

      I hope this helps. Email me at caldwell@biotechink.com if you have more questions.

      All the best,

      Susan

  10. atjuncture says:

    Hi Dr. Caldwell,

    Firstly, I would like to thank you for your pieces. They are so specific and your advices are extremely helpful!

    It isn’t easy to land a job in medical writing and would like to seek your advice if I am on the right track:
    I am currently a drug safety specialist in a CRO and hold a BSc. in the life sciences (with specialization in biomedical science). Should I be looking to further my studies (I’m looking at a full time MSc in pharmacology) or would waiting for internal transfer opportunities within the company into the medical writer role be a better bet? If it’s the latter, I’m not even sure if my current qualifications would make me an eligible candidate!
    Meanwhile, I will be going for certification courses to hone my medical writing skills and to get more exposure.

    I’m stuck as to what to do next. Please advice and thank you once again!

    Best regards,
    Nicole

    • Nicole,

      Glad you are finding my blog posts helpful.

      You’re right, medical writing jobs aren’t easy to come by. However, you have a great background in drug safety, which is in huge demand in the biopharmaceutical industry. Regarding your qualifications in general, I know many medical writers who are very successful with a bachelor’s degree and some industry experience. It is also true that an advanced degree in the life sciences is a definite advantage when competing in the job market.

      You could continue your current job for a while, but use your spare time to take courses in medical writing from DIA, AMWA, or some universities, so that you’re continually improving your resume. Over time, you should also develop a medical writing, rather than a drug safety, resume. Your MW resume will emphasize all of your writing experience, and will set you up to apply for a medical writing position in the future.

      Whether you go for an advanced degree will depend on circumstances–time, money, desire, and opportunity. But in general, these steps will migrate you into position for your first medical writing job. Whether it’s a freelance position or a permanent job, either will give you the experience you need writing IBs, protocols, CSRs, and full regulatory submissions. At that point, you’ll be on your way!

      Warmest wishes for success,

      Susan

  11. Erin C. says:

    Dr. Caldwell:

    Like many others here, I stumbled upon your blog while looking into medical writing as a new career direction for myself.

    I read your article on this page, and am still not certain if my experience might what it takes to get into the medical writing industry. Could use your insight.

    I have a BA in English/Creative Writing. Also have an associates degree and technical certification as a radiology technologist (i.e. x-ray technologist). I’ve been working for over three years as a tech, but am feeling like I need to move into something less direct patient-care oriented. I’d like to combine my writing skills with my medical knowledge (A&P; medical terminology; etc.)

    Creating a portfolio is my next step …

    Do I have the basics that might work in this career?

    Thank you,
    Erin

    • Erin,

      You definitely have a background that could lead to a medical writing career. Some of my colleagues in the field have college degrees in English, and they have done fine. However, they also have industry experience, which is where you need to beef up your resume. For the most part, if you haven’t worked in drug development (ie, the biotechnology or pharmaceutical industry), you will have a hard time writing about the drug development process. You can look to AMWA and DIA for online and in-person medical writing courses that will supplement your knowledge, too.

      Preparing for a career in regulatory medical writing requires investing many years and acquiring a lot of education and work experience. But it’s time well invested and that pays the writer back many times over in the career satisfaction and enjoyment later on. You just have to decide whether the effort is worth it for you and if that goal fits with your life plans.

      I wish you all the best,

      Susan

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