Archives for May 2012

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.

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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.
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• 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.
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• 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.
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• 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.
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• 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.

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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.

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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.

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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.

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Image credit jannoon028@FreeDigitalPhotosl

In my last post, I mentioned that I had covered a medical conference in Boston last week. I received a few emails in response, from people who’d read the post and had some questions about what medical writers do when covering a conference.

Anne Marie from St. Paul, MN, was curious about how, if at all, I prepare for an upcoming conference, and I promised I’d respond in the form of a post.

So here it is!

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8 Things To Do Before The Conference
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1. Register:  As soon as you know you are going to be covering a certain conference, visit their online site & register. Be sure to look for a link for “Press Registration” – basically this allows you to register for free. You’ll likely be asked various questions like “Which organization will you be working for?”, and maybe details of their geographical location. Conferences differ in what they ask you as you register, so just play it by ear, and if they ask any questions that you can’t immediately answer, check in with your news organization’s editor for the answers.
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2. Check out the “Press Information”: This area of the website will provide you with all the information that you’ll need to do for that specific conference. The information may be updated as you get closer to the conference dates, so keep checking for updates that might be helpful for you.
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3. Request a letter of assignment: Ask the editor (of the medical news organization that has contracted you) for a “letter of assignment” for the meeting. This basically will be a note on company letterhead to state that you are working for them and need a pass to attend the conference, as well as access to the press room. This will be your entrance ticket for the meeting on the day!
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4. Select your presentations: Check out the abstracts – these don’t usually appear on the website until a month or so before the meeting, but it’s worth keeping an eye out for them every so often. Once they appear, spend some time pouring through them & select however many you need to report. Check your selection with the editor – just because you like how a topic sounds, doesn’t mean they will. Not everything is appropriate for their needs, so you can maximize the chances of your reports being published (and therefore you getting paid!) by sending the abstracts to the editor in advance so that he or she can give you the thumbs-up.
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5. Sign up for embargoed abstracts: Many abstracts will be embargoed until just a couple of days before the conference. When this is the case, the conference website may list an email address that you can contact to “subscribe” to embargoed abstract alerts. They may not end up being useful to you, but it doesn’t hurt to have them, just in case.
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6. Contact the authors: Most news companies like to have some kind of a direct quote from one of the researchers in your article. Naturally, you can save getting this until the day of their presentation, but be prepared to wait in line if you choose this option, and maybe even chase them around to finally get hold of them! And then multiply this wait by 10 articles, or however many you have to write. So emailing authors in advance can be very useful. Not only does it help you in your quest for a quote, but it also can be helpful for the author. Some people prefer to have some time to construct a well-thought-out response to questions, rather than just having to answer on the fly into your recording device. So you may have to dig out email addresses for the first authors by doing some online searching – not all abstracts include their email addresses – but it can be a worthwhile venture. Once you have their addresses, send out a polite email to introduce yourself and let them know you’re covering the conference and have selected their presentation to report. I usually attach my letter of assignment to the email, so that the author can see that I’m contacting them legitimately. And in the email, I’ll ask a few questions about the research study that will help get me enough information to use as a quote or two in the article.
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7. Start putting articles together: Conferences can be busy, and you might have limited time to complete your articles after attending the presentations. So to try to combat this somewhat, as a head start, I get my Word documents ready in advance for each article. Most news organizations will request that you forward a copy of the original abstract with your news article – so I prepare a 2-page document for each article. I tag the abstract onto page 2. And the first page I “prepare” as best I can for the actual article. I try to think of a title & get that situated. If I have a specific template to follow, I’ll get a skeleton of it in place so that I can just plug in my news information on the day – this might just mean adding in authors names, dates, the meeting information, my name, etc, etc. But it’s amazing how helpful it can be to get some kind of a skeleton in place.
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8. Check in with your editor: Often, you’ll be contracted to cover a conference many weeks or even months before it takes place. Other than checking in with the editor with your list of abstracts to cover, previous to that, there’s no real need to contact him or her. I’m someone who likes to be on the end of good communication, so I tend to treat my clients similarly and assume that they too are comforted by a well-timed email check-in, even there isn’t really anything to report. In the case of my last meeting, after my initial communication with the editor to accept the conference assignment, a few weeks of silence went by, and I then just sent a quick email to say hi, and let her know I was still on the radar, abstracts hadn’t yet appeared, but I’d be in touch as soon as they popped up on the site. I think it just breaks the silence a bit, and reassures the editor that you’re still in the game. And I think this tactic is especially useful if you’re reporting for an organization for the first time – it gives them some confidence that you’re responsible, professional, and reliable – and that you’re taking their work seriously. Then I tend to check in with the editor the day before the conference begins, just to let them know I’m ready and prepared. I usually let them know they can contact me by email at any time during the conference if they need me, and I’ll send my cellphone number too, in case they have any urgent last-minute requests.

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And that’s it, really.

It sounds long-winded, but most of it is just habit. And if you’re working in science, likely you’ll be accustomed to doing much of this kind of thing in advance anyway, but as a non-media participant! So I’m sure a lot of what I’ve said will be second nature to some of you, but just with a slightly different angled approach.

So hopefully this has been helpful insight into preparing for a conference. It’s by no means a must-do list – everyone has their own approach – I know writers who do much more than this in advance, and some who do minimal preparation, instead saving everything for the meeting itself. Much of it will boil down to individual preference – some folk prefer to feel prepared, and others work better on the fly. There’s no single correct approach here.

But I hope it’s been useful in particular for new medical writers, or anyone who is coming up on reporting their first conference.

Feel free to leave any of your tips as comments too – everything will be helpful to new medical writers!

 

Image Credit David Castillo Dominici @FreeDigitalPhotos