Can I Succeed as a Freelance Regulatory Writer Without Industry Experience?

Because I keep getting asked this question, I’m going to address it very directly in this post. I know there are many folks who want to do regulatory writing, but they don’t want to have to get a job in the drug industry to accomplish this goal. For those of you who have medical backgrounds, in particular, I certainly understand your position.

However, becoming a successful freelance (contract) medical writer is extremely difficult, if not impossible, without industry experience.

It gets down to this: you can’t write well about something you don’t understand, and you must have a reasonably thorough understanding of the drug/biologic development process in order to write clinical and regulatory documents about it. (I’ve covered this issue in more detail in my article, “What It Takes to Be a Medical Writer”.)

In the future, there may be numerous books that can teach you the things you learn when you work in the drug industry, but as of now, I’m not aware of any that can deliver that kind of knowledge. It’s also unlikely that a prospective employer will hire you if they see you’ve never worked in the industry and never written the documents that they need help with (eg, investigator brochures, study protocols, clinical study reports, amendments, annual reports, INDs, NDAs, and BLAs). Those documents are almost always written by in-house writers or *experienced* contract writers. Why? It’s actually simple. Those documents are too important to the company’s success to trust them to a writer who can’t show that they already know how to write them.

Drug companies spend a great deal of money to do preclinical research and clinical testing of their candidate drug products. This is what the company is all about, and the ultimate goal is to get the drug approved for commercial sale. To get the drug approved, the company does its research and then prepares an NDA (New Drug Application) or BLA (Biologic License Application) that summarizes literally everything that is known about the drug (by the company or any other source). This NDA or BLA, a full regulatory submission, requires many months and many people to write, review, format, and prepare for delivery at the offices of the FDA or other regulatory agencies. Often, the future wellbeing of the company depends on whether or not the drug is approved on the basis of that submission.

The writing of the submission, therefore, is a big responsibility. The regulatory writer has a major role in developing the full regulatory submission when the drug is ready to be considered for approval.  This pivotal position requires a regulatory writer who has a good understanding of the drug development process, because that’s what the documents are all about. It also requires a writer who understands medical concepts and medical research terms, and who knows the requirements of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).  The principles of ICH must be applied when writing and formatting regulatory documents.

The job of a regulatory writer is very technical and requires the application of medical and legal knowledge. Working in a related position (eg, drug safety, medical writing, or clinical research) in the highly regulated biopharmaceutical industry is an education in itself, and it is excellent preparation for a career in regulatory medical writing.  For those who want to transition into regulatory writing, there are many routes from which it can be done, but experience in the drug industry is a firm foundation for which there is just no substitute.

Copyright 2016  Biotech Ink, LLC  All rights reserved.

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Terrific Blog Article on Working From Home

With Matt Gemmell’s permission, I highly recommend his blog article, Working From Home. He’s been working from home for over 7 years, and certainly knows wherewith he speaks. Although not a medical writer, he IS a writer, and his musings reflect, to a large extent, what happens when medical writers try to work from home.

Lots of questions surface when people think about working from home, especially if it’s to be a full-time arrangement. Matt answers many of those questions, among them the main problem–being disciplined:  “The main problem you’ll encounter when working from home is… well, you. We need constraints in order to reinforce productive behaviour. The idea of a work ethic goes out the window for most people when no-one is looking over your shoulder. Some people can just work diligently, regardless of whether anyone is checking up on them. That’s fantastic. Most of us, however, need some help.”

Matt goes on to discuss the ways  we can make our work at home productive and enjoyable–and I think he nails the issues thoughtfully and honestly. Hope you find his article helpful.

Copyright 2014-2016  Biotech Ink, LLC. All rights reserved.

What It Takes to Be a Medical Writer

Many folks ask me what you have to do to be a medical writer. I think a better question is this: What does it take to be a regulatory medical writer? 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 categorize my thoughts on what it takes to be a medical writer into two groups: what you can do, and who you should be.

First, the easier one–what you must do:

(1) Get some specific training, depending on where your gaps are. Look at the American Medical Writers Association (AMWA) and Drug Information Association (DIA) web sites, because there are numerous 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, 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.

Copyright 2012-2016  Biotech Ink, LLC. All rights reserved.

10 Reasons Why You Really Should Be on Twitter

Susan E CaldwellIt turns out that medical writers have been and are still underrepresented on Twitter, at least for now. In 2009, I started tweeting (username: susanecaldwell). I took the plunge–out of curiosity more than anything else–but  also thought I might be able to use Twitter to market my medical writing business. Admittedly, I went into the endeavor with a common misperception about Twitter. It’s NOT just a garbage can full of inane, boring comments from people who have nothing to do. Little did I know how cool and useful it would be….

twitter-logoHere’s my short list of good reasons why you (especially if you’re a writer) should be on Twitter.

1. Drive traffic to your web site (assuming you have a web site). You do this by talking about your interests and expertise in your tweets (140 characters or less). You provide your readers with valuable, useful content, and they will come and see. If you’re selling your products and/or services, the valuable content, in turn, confers credibility on you and your business.

2. Build an internet presence, a corollary to #1 above. Your internet presence should be a composite picture, with your Twitter page, your web site, blog, Facebook page, RSS feeds, and other such communication tools. After all, all of this is about communication in various formats.

3. Let the world get to know you. We all like to do business with people we know, or at least know something about. Twitter lets you converse with the online world, in little snippets. If you let people get to know you, they may find you and eventually trust you–with a project, a date, a job, or another open door (such as a referral).

4. If you’re a writer, lead the world to your writing. Send the world to your blog, web site, RSS feeds, newsletters you’ve contributed to, ezine articles, technical publications, and much more. Don’t just trust that they’ll find the writing samples that are buried in your web site. Use hyperlinks when needed–and don’t assume that the folks who are looking for you will be able to find you without them.

Networking with computers5. Network for all you’re worth. This, of course, feeds into letting the world get to know you, and helps spread the word about your writing. Twitter is a great, living repository of knowledge and resources, many of which are of interest to writers, including medical writers. You can follow authorities in your field, including medicine, health journalism, healthcare, medical writing, physical therapy, and more. Check out those Twitter sites, and they will send you to still more sites, many of which will be related to your interests. All of those sites are by people–tweeting their hearts out about what they know.

6. Increase your knowledge–learn! We can all learn from sharing knowledge that’s getting spread every day on Twitter. All those tweeters (people), searchable by name, expertise area, city, and other terms, have information that will supplement yours. Follow their tweets and you’ll find new resources and information for doing your job, expanding your hobby, or finding a mate–whatever it is that you’re interested in learning about. From a learning perspective, Twitter can be viewed as a way to cross-reference people and their knowledge and resources. And don’t forget to check out some Twibes (Twitter Tribes), like my Medical Writers Twibe (these are special-interest groups that will make it easier to learn and connect).

7. Expand your world and tweeting expertise. The Twitter world is growing faster than ever. Twitter is an enormous market to which you can speak, show your work, write for, and network in. In fact, current projections for Twitter’s growth in the next 5 years approach the astronomical. By becoming a tweeter now, you will reach many, many people in the coming months and years. In turn, reaching these people, you may greatly enrich your professional and personal lives.

8. Find a job. There are tons of recruiters, agencies, and human resources departments on Twitter. You can search by job title, agency name, names of people in a given field, and much more. What an amazing way to job hunt!

9. Find a gig. There are also many, many resources on Twitter for finding freelance writing projects. Same methods for searching apply as in #8 above.

10. Use those cool Twitter apps. There are many applications (apps) online that can be used in conjunction with Twitter. They make it easier to broadcast info about yourself and your work, easier to find others in whom you are interested, and allow you to tweet from nearly anywhere you may be on the planet. You may want to wade into Twitter with just a few tweets, and tackle the apps later, when you understand more about how Twitter works. No rush to use these–they just make your Twitter life a little easier and more efficient. You can find them by Googling Twitter apps.

Dive in, if any of these areas interest you! I found that the best way to learn to use this amazing network is to just jump in, create an account, and start trying. Put a tweet out there and see who responds. Similarly, search some terms of interest, and start following people who pop up in the search results. Start following the folks on Twitter who interest you. And follow the ones who start following you. You’ll be amazed at what happens.

Copyright 2012-2016  Biotech Ink, LLC. All rights reserved.