Monday, May 25, 2009

Clinical Trials Reports

I thought I was going to have this ready by now, but with my move out of Texas and all the work with a book we are working on, the Clinical Trials Reports course had to wait. 

We seem to be back on track with this and, if all goes well, we'll be releasing this course at next month. Just to give you a preview, these are some of the topics included in the online course:
  • Pre-submission Quality Control
  • Pre-IND, Pre-IDE
  • IND, IDE
  • Investigator Brochure
  • NDA, PMA
  • Panel Pack
  • Post-approval Reports
  • Recurring Regulatory Reports
  • Manuscripts & Abstracts
If you are not familiar with regulatory writing, you may want to look first at Introduction to Regulatory Writing in the US. The upcoming course is a great follow-up to that one, and it will show you how to write all these important reports. 

Sign up for email updates to this blog (see right-hand column) to be notified when the course is released.

Two Medical Writing Positions Available in the UK

Friday, May 22, 2009

More to Medical Writing Than Meets the Eye

By Cyndy Kryder (Guest blogger)

Think you only need to understand science to become a medical writer? Think again. Despite the term medical in the phrase medical writing, when you work in this field you won't be writing exclusively for medical professionals.

Depending on your niche and expertise, in addition to doctors, nurses, and other health care professionals, you might be writing for a lay audience (that's the common person), hospital purchasers, manufacturers and users of medical devices, pharmaceutical sales representatives, people in the insurance industry, or individuals who create and enforce public policy. That's a very broad range, and each of those groups will bring with them a different set of terms. To do your job well, you'll need to have a basic understanding of the language that's unique to each segment. Why? Because the more you know, the more marketable you'll be. And in today's economy, that's important.

So not only will you need to understand medical terminology, you'll also need a working knowledge of terms related to:

  • Health care
  • Insurance
  • Business and marketing
  • Education

You see, medical writing is not really one distinct genre, but one with a very broad scope and multiple components. In my opinion, medical writing falls into 3 categories: regulatory, promotional, and educational.

Regulatory writing, a very scientific type of writing, involves translating complex information from clinical trials into technical reports, some of which will be submitted to the federal government. Included here are study protocols, Investigator's Brochures (which are distributed to the scientists who head up clinical trials), patient narratives, and, in some instances, manuscripts detailing the outcomes of clinical trials that will be submitted to medical journals.

Promotional medical writing includes any materials created to promote, or sell, a prescription drug, intervention, or medical device. These could be any of the multitudes of sales-training materials (in print and other media) that are used to teach sales representatives about how a new drug or device works and to train them to sell it to prescribers. Target audiences for promotional materials are broad, and include the folks who sell the product, those who prescribe it, those who have influence on people who might prescribe it, and those who ultimately will cover the cost, either all or just a portion (third-party payers).

Into the educational category I lump anything a writer creates for continuing medical education (CME) programs, including writing needs assessments, as well as the content for the actual CME programs. I also consider patient education materials to be educational writing, since one of their purposes is to educate the consumer and family. I recognize that the ultimate goal of these materials may well be promotional, that is, to educate consumers to the point where they will ask their doctors to prescribe the product for them; however, I consider them educational, since they differ in style and tone from promotional pieces.

So you can see the target audiences for whom you could be writing can be quite diverse. And that's why you need to be knowledgeable about more than just medical terms.

Before you panic, throw your hands up in despair, and decide that medical writing is not for you, take a deep breath and calm down. You can do this. How do I know? Because I did.

Even though I had a bit of a science background when I entered the field, I still surrounded myself with great resources, like the ones that follow. If you're serious about becoming a medical writer, add some of these resources to your medical writing toolbox. You'll find them indispensible.

AMA Manual of Style: A Guide for Authors and Editors. This guide for authors and editors belongs on every medical writer's bookshelf.

Dorland's Illustrated Medical Dictionary, 31st edition. A must-have resource, this dictionary provides definitions for almost any medical term you'll come across.

Managed Care Digest Series®; Developed by the pharmaceutical giant, sanofi-aventis, this annual series of free hard-copy or electronic digests includes the Hospitals/Systems Digest, the Senior Care Digest, the eManaged Care Trends Digest, the Government Digest, and the HMO-PPO Digest. The individual digests contain information about all the major components of health care delivery and provide updated information and statistics incorporating data from Verispan.

mediLexicon; A searchable, online medical dictionary, mediLexicon provides definitions for terms, phrases, acronyms, and abbreviations. Powered by Stedman's Medical Dictionary and geared toward professionals, this site defines more than 100,000 medical terms.
Cyndy Kryder is an experienced freelance medical writer with more than 16 years of experience. As one-half of the Accidental Medical Writer writing team, Cyndy writes books for aspiring and experienced medical writers. You can find more medical writing tips at her website. Article source here.

Tuesday, May 19, 2009


The Texas Heart Institute in Houston, Texas, is seeking a senior scientific medical editor/writer for the section of Scientific Publications. The editor/writer in this position will be responsible for editing and writing all types of scientific publications and for managing publications projects. Applicants must have excellent written, editorial, and project management skills. Candidates should have at least a bachelor's degree in English, journalism, or science (with proficiency in English); a graduate degree is preferred. Applicants should also have 5 years' experience or commensurate academic or research experience. Advanced degree qualifies for experience. Completion of AMWA's certificate programs and BELS certification preferred. Candidates will be required to complete a short grammar and writing test and to provide writing samples.

Qualified applicants should send a résumé to Marianne Mallia, ELS, Texas Heart Institute, PO Box 20345, Houston, TX 77225-0345; FAX: 832.355.3714; e-mail: .

Monday, May 11, 2009

AMA Manual of Style Online

AMWA members get a discount on the AMA Manual of Style: A Guide for Authors and Editors by subscribing through

Medical News Writer Position

Medscape Medical News has an immediate need for a medical news writer to cover the American Association of Clinical Endocrinologists 18th Annual Meeting and Clinical Congress (AACE), 5/13 - 5/17, in Houston.

The oral abstract and poster sessions start on Thursday, May 14. We would like to get 5 articles from the meeting and can pay $300 per article.

Each article should be about 400-800 words. Each article should have interviews with at least two sources, (1) the presenter/lead investigator and (2) an independent commentator who can provide perspective on the study's findings. Preferred independent experts include (a) the session moderator and/or someone from the society board (president, vice president, etc), (b) someone recommended by the presenter as someone who can comment on the study, or (c) a random attendee of the session (last resort). Most important is that the independent commentator not be involved with the study (hence, the independent part).

The writer would need to register him- or herself as press directly with the society. A letter of assignment can be provided by Medscape if needed.

Once coverage is arranged, I can send style guidelines and sample articles. Please send resume and clips at first contact to .

Thursday, May 7, 2009

Social Media and Medical Writing

I thought that because I have a few blogs and a fairly active Facebook account, I had a pretty good grasp of social media. But I've discovered there is a lot to learn from some recent readings. 

Anyway, we have been exploring how to reach other audiences through social media, especially when you take into account that in February 2009, social network usage exceeded Web-based e-mail usage for the first time (click here for the Nielsen report, The Global Online Media Landscape). For instance, our approach on the NNii web site has been the traditional text article with scientific references. But should we be adding videos, tag clouds, Twitter and Facebook pages? Should we hire a teenager to do all this?

One great example of integrating social media into health communications is the Web site of the Centers for Disease Control and Prevention, They offer podcasts, mobile alerts, videos, widgets,  facebook group, and more.

If you want to learn more about using social media, there are a lot of books, blogs and twitter feeds out there. I'm reading an ebook called The Zen of Social Media Marketing, which seems pretty good so far.

Thanks for reading!

Freelance & Full-Time Medical Writing Jobs

Monday, May 4, 2009

Medical Writer Position in Houston

Experienced professional writers with bioscience background needed at the John M. Eisenberg Clinical Decisions and Communications Science Center at Baylor College of Medicine in Houston. Work as part of a dynamic team of professionals translating medical research reviews into information products for clinicians. MA or MS required, PhD preferred. Must be an excellent writer with bioscience knowledge and comfortable with medical research reports and methods. Send cover letter, resume, writing samples and three references to Tom Workman at Baylor College of Medicine is an equal opportunity employer.