Friday, July 18, 2008
Thursday, July 17, 2008
Guidelines for Reporting Research Data
There are two primary guidelines that you can follow when writing about randomized and observational trials: the CONSORT and the STROBE statements. The CONSORT (Consolidated Standards of Reporting Trials) statement was issued in 2001 and The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) was issued in the fall of 2007. Both statements have been included in the publishing guidelines of several national and international journals. Each of these statements details a check-list of items to include when writing about randomized or observational studies that you should be familiar with as a medical writer. You can learn more about the statements in the articles below.
- von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007 Oct 16;147(8):573-7.
- Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001; 134(8):657-662.
- Altman DG, Schulz KF, Moher D, Egger M. Davidoff F, Elbourne D, Gøtzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134(8):663-694.
Tuesday, July 15, 2008
Medical Writing Jobs
Because I get a lot of emails asking about job opportunities, I will start posting links to ads I became aware of. Here are a couple.
Monday, July 14, 2008
Is Medical Writing Really a Six-Figure Occupation?
A few days ago, someone challenged me saying that medical writers can't earn six figures. Well, did I make that up?
Of course, not all medical writers will make such money. Salaries are always tied to experience, education, type of employer, etc. But at the high-end, many medical writers are earning six figures. In fact, according to the 2007 AMWA Salary Survey, the mean gross income for the freelancers interviewed was $119,295. Click here to read more about the results of the survey.
You may also look at the ranges posted in ads for medical writing job: you'll see that the high-end of the ranges are above 100K. See this post about Medical Writer Salaries in USA.
The potential is there. You just have to work hard to get to that level.
Thanks for reading!
Of course, not all medical writers will make such money. Salaries are always tied to experience, education, type of employer, etc. But at the high-end, many medical writers are earning six figures. In fact, according to the 2007 AMWA Salary Survey, the mean gross income for the freelancers interviewed was $119,295. Click here to read more about the results of the survey.
You may also look at the ranges posted in ads for medical writing job: you'll see that the high-end of the ranges are above 100K. See this post about Medical Writer Salaries in USA.
The potential is there. You just have to work hard to get to that level.
Thanks for reading!
Wednesday, July 9, 2008
Regulatory Writing
One could say that regulatory writers (either freelancers or employees) may be the best paid in the medical writing industry. That is because their clients/employers are usually pharmaceutical companies with lots of cash.
What do regulatory writers do? They prepare documents that need to be submitted to regulatory agencies such as the Food and Drug Administration (as well as clinical trial reports and investigator brochures). Here's a description of some of these regulatory documents.
Investigational New Drug Application (IND)—the company requests permission to test a drug in humans. The IND includes scientific information about the chemical composition of the drug, an overview of previous animal studies, and whether the drug has been used in humans overseas. If the drug has been tested overseas, a complete summary of all efficacy and safety information to date also needs to be submitted.
New Drug Application (NDA)—the company has completed its research in humans and now submits the results in the NDA. This comprehensive document contains data on the effectiveness and safety of the drug obtained during preclinical and clinical trials.
Common Technical Document (CTD)— in the early 1990s, regulatory authorities and experts from the pharmaceutical industry from Europe, Japan, and the United States created the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH seeks to harmonize the interpretation and application of technical guidelines and requirements for product registration to avoid the duplication during the development of drugs in every region. As a result of this harmonization came the CTD, which includes information on how the product is administered and prescribed and other documentation on the drug’s quality, safety and efficacy. The CTD was designed for use in Europe, Japan, and the United States.
Marketing Authorization Application (MAA)—the company submits an application requesting marketing authorization of the drug in the European Community, which includes chemical and clinical data on the drug.
Regulatory writing is not for everyone. Usually you need an advanced degree to break in. But if you like it and are good at it, you're in for a rewarding job.
What do regulatory writers do? They prepare documents that need to be submitted to regulatory agencies such as the Food and Drug Administration (as well as clinical trial reports and investigator brochures). Here's a description of some of these regulatory documents.
Investigational New Drug Application (IND)—the company requests permission to test a drug in humans. The IND includes scientific information about the chemical composition of the drug, an overview of previous animal studies, and whether the drug has been used in humans overseas. If the drug has been tested overseas, a complete summary of all efficacy and safety information to date also needs to be submitted.
New Drug Application (NDA)—the company has completed its research in humans and now submits the results in the NDA. This comprehensive document contains data on the effectiveness and safety of the drug obtained during preclinical and clinical trials.
Common Technical Document (CTD)— in the early 1990s, regulatory authorities and experts from the pharmaceutical industry from Europe, Japan, and the United States created the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH seeks to harmonize the interpretation and application of technical guidelines and requirements for product registration to avoid the duplication during the development of drugs in every region. As a result of this harmonization came the CTD, which includes information on how the product is administered and prescribed and other documentation on the drug’s quality, safety and efficacy. The CTD was designed for use in Europe, Japan, and the United States.
Marketing Authorization Application (MAA)—the company submits an application requesting marketing authorization of the drug in the European Community, which includes chemical and clinical data on the drug.
Regulatory writing is not for everyone. Usually you need an advanced degree to break in. But if you like it and are good at it, you're in for a rewarding job.
Monday, July 7, 2008
AMWA Annual Conference Brochure
AMWA has posted the program for this year's conference. As usual, there are open sessions and workshops on every type of medical writing and more.
Registration opens on July 21. Check the brochure here.
Registration opens on July 21. Check the brochure here.
Wednesday, July 2, 2008
Magazine Writing Tips For Freelancers
By Victor Epand (Guest blogger)
Writing for magazines is a good career, just keep in mind that it requires patience and ingenuity. To take advantage of this freelance opportunity, all those who are interested can find these tips useful:
Query magazines: First you need to find out publications that would want the type of articles that you are writing. Once this is done find out what these magazines want in particular. Find what type of articles they expect - short articles, personal stories, academic and researched articles, or if they need it for a specific target audience like for parents or kids. You could enquire about their guidelines, their do's and dont's for freelancers. Sometimes they may in turn request you to mention specifics, like your expertise, your targeted word count, and so on.
Write to your strengths: Often writers will already be into certain areas of expertise. It is advisable and easier to write on what you enjoy writing about, according to your skills, background and knowledge base. Identify your forte and then start writing articles for the appropriate magazines. Many magazines publish articles on specific areas like science and engineering, photography, history related, home decor and so on.
Professionalism: Often many aspiring writers are willing to write at lower prices. Others do it as a hobby along with some other sources of income. You should present yourself as organized and efficient, but charge appropriately.
Communicate with the editors: Good writers make it a habit to communicate with the editors. In case you have a question about the article, you should have it clarified with the editor. Also, if the editor has anything to communicate to you, make sure that you contact him in a professional manner. Even if there is some issue relating to the deadline, it is better to tell the editor about it. The professionalism in your communication can be helpful for future assignments.
Research, follow guidelines, outline, write, revise and submit: Once you get an approval from the publisher, follow your normal writing procedure. Carry out necessary research on the subject, find out the factual details and countercheck them. Make an outline of the content on the subject. Based on the outline, write the article keeping in mind the guidelines and read it thoroughly before you submit.
While writing, make sure the guidelines about the word count and the usage of keywords are strictly followed. Be prepared to rewrite if necessary. Whatever guidelines that were given by the publisher need to be followed.
Victor Epand is an expert consultant about magazines and comics. Article source here.
Writing for magazines is a good career, just keep in mind that it requires patience and ingenuity. To take advantage of this freelance opportunity, all those who are interested can find these tips useful:
Query magazines: First you need to find out publications that would want the type of articles that you are writing. Once this is done find out what these magazines want in particular. Find what type of articles they expect - short articles, personal stories, academic and researched articles, or if they need it for a specific target audience like for parents or kids. You could enquire about their guidelines, their do's and dont's for freelancers. Sometimes they may in turn request you to mention specifics, like your expertise, your targeted word count, and so on.
Write to your strengths: Often writers will already be into certain areas of expertise. It is advisable and easier to write on what you enjoy writing about, according to your skills, background and knowledge base. Identify your forte and then start writing articles for the appropriate magazines. Many magazines publish articles on specific areas like science and engineering, photography, history related, home decor and so on.
Professionalism: Often many aspiring writers are willing to write at lower prices. Others do it as a hobby along with some other sources of income. You should present yourself as organized and efficient, but charge appropriately.
Communicate with the editors: Good writers make it a habit to communicate with the editors. In case you have a question about the article, you should have it clarified with the editor. Also, if the editor has anything to communicate to you, make sure that you contact him in a professional manner. Even if there is some issue relating to the deadline, it is better to tell the editor about it. The professionalism in your communication can be helpful for future assignments.
Research, follow guidelines, outline, write, revise and submit: Once you get an approval from the publisher, follow your normal writing procedure. Carry out necessary research on the subject, find out the factual details and countercheck them. Make an outline of the content on the subject. Based on the outline, write the article keeping in mind the guidelines and read it thoroughly before you submit.
While writing, make sure the guidelines about the word count and the usage of keywords are strictly followed. Be prepared to rewrite if necessary. Whatever guidelines that were given by the publisher need to be followed.
Victor Epand is an expert consultant about magazines and comics. Article source here.
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