Thursday, July 31, 2008

Medical Writing: Reporting About Confounders

You have heard it in the radio or watched on TV. The news reporter is talking about the latest study that shows that video games are related to school violence. That's it, no more details about the study population, or the possible confounders. Just the conclusion of the study in sound-bite format.

Should you just accept the conclusion of that study at face value? If you're a savvy medical writer, you know that the conclusions in epidemiological studies may be affected by what is known as confounders. What are confounders?

Confounders (or “confounding variables”) are factors that are independently associated with a risk: they can make it appear as though two unrelated things are actually related. Epidemiology statistical tests can control for these factors, as long as the factors are measured during the study. Common confounders that are controlled for in epidemiology are age, gender, socioeconomic status, and lifestyle factors such a whether a participant is a smoker.

For example, suppose a researcher was interested in the relationship between gender and common heart attack symptoms. The researcher might see that women have a different symptom pattern than men and conclude that there are heart attack pathology differences between men and women. However, a closer look at the data might reveal that women were an average of 15 years older than men when they experienced their first heart attack. This finding would be important, because age has been associated with uncommon heart attack symptoms in past research studies. Therefore, it would be possible that the older age of the women, rather than a difference in disease pathology, was responsible for the differences in symptoms among men and women (i.e., age is a potential confounder).

When writing a paper or reporting about a study, make sure that the researcher has collected as much information on possible confounders as possible and has controlled for them. Otherwise, the conclusions of the study would not be valid.

Click here if you want to learn more about epidemiology and biostatistics.

Monday, July 28, 2008

Technical Writing - Tech Writer Salaries in the US

By Bryan S. Adar (Guest blogger)

Being a technical writer can be a lot of fun. You get to meet a lot of people, write about a variety of topics, and, if you're lucky, get to do some travel. But let's talk about the bottom line - how much money can you make as a technical writer?

It's hard to say how much money full time freelance technical writers make. But we do have some data on salaries made by full time technical writers working for a company.

Let's take a look at the percentile salary estimates for technical writers. (Note: The following data is based on research in the U.S. If you live outside of the U.S., you should research technical writing salary statistics in your region.)

Percentile 10% / 25% / 50%(median) / 75% / 90%

Hourly Wage $18 / $22 / $29 / $37 / $45
Annual Wage $36,490 / $46,680 / $60,390 / $76,650 / $94,550

Source: U.S. Department of Labor

Note that those in the top 10% average $94,550 a year. That's a pretty good salary for a technical writer. Can you make $90,000 plus per year as a technical writer? The answer to this question depends on two factors:

1. Your level of experience

Broadly speaking there are three levels of technical writers:

Entry level technical writers - 0 to 3 years of experience

Mid level technical writers - 3 to 7 years of experience

Senior level technical writers - 7 plus years of experience

Let's match these three levels to the annual wages in the chart. If you're an entry level technical writer, you fall into the 10 - 25 percentiles and make between $36,490 and $46,680 per year. A mid level technical writer falls into the 50% percentile and makes $60,390 a year. Senior level technical writers at level three make between $76,650 and $94,550 a year.

You have to be a senior level technical writer to make $90,000 plus per year. This doesn't mean it will take you seven years to become a senior level technical writer. For some of you it may take longer. For others the journey will be shorter.

It will also depend on which companies you worked for and the degree of complexity of your projects. If you have worked on complex projects at major companies you can apply for senior level technical writer jobs for sooner than seven years.

2. Your location

State and local taxes and standard-of-living play a part in determining your salary also. The pay level is higher in some states than in others. Technical writers get paid more in California and Massachusetts as opposed to Texas and Louisiana.

Top paying states for technical writers:

State Hourly Mean Wage Annual Mean Wage

California $36 $75,470
Massachusetts $35 $72,820
Washington $35 $72,490
New Hampshire $34 $69,680
Nevada $33 $69,530

Source: U.S. Department of Labor

Keep in mind that these are averages. You could make more or less depending on your skill and experience.

Whatever your location or skill level, these figures show that there's a lot of opportunity for technical writers, and there's potential for a good income.

Being a tech writer is a great job. Go interesting places, meet really smart people, learn new things and make really good money. Which is why it's such a rapidly growing profession. The down side, though, is that there are people who get into the business without knowing as much about it as they should.

If you want to become a technical writer try out these free weekly exercises. They are easy and fun to do. You'll also learn common tech writing terms and current industry trends. Article source here.

Friday, July 25, 2008

2008 AMWA Annual Conference Registration

AMWA's 68th Annual Conference
Louisville, KY
October 23-25, 2008

Just a reminder: Registration opened this week and workshops and roundtables fill up quickly. Click here to register.

This year I will be leading a breakfast round table on Thursday about Self-Publishing; a dessert klatch about blogging also on Thursday; and an open session on Friday about Communicating Health Risks.

Thursday, July 24, 2008

More Medical Writing Positions

Senior Science Writer - Children's Hospital Trust, Boston, MA

Chaloner Associates is recruiting a Senior Science Writer to join Children’s Hospital Trust, the philanthropic resource for Children’s Hospital Boston. The largest pediatric medical center in the U.S., Children’s Hospital has been rated one of the nation’s top hospitals by U.S. News & World Report for 14 consecutive years. Children’s is the primary pediatric teaching hospital of Harvard Medical School and also home to the world’s largest pediatric research facility.

The Senior Science Writer works with the Associate Director, Development Communication and major gifts officers to create high quality fundraising proposals, case statements, promotional literature, feature articles and other development communication materials as needed. The Senior Science Writer is a creative, articulate and adaptable professional who successfully executes multiple projects on budget and deadline. He or she is proactive, taking responsibility for helping senior development officers identify and define communications needs. This position reports to the Associate Director, Development Communications and also works closely with members of the major gifts and individual giving teams.

Key Responsibilities:
♣With senior development staff, and in collaboration with the medical and research staffs, determines the most effective vehicles for meeting specific fundraising communications needs and oversees their production.
♣ Writes and produces fundraising proposals and newsletters. Translates proposals into brochures and promotional literature as appropriate.
♣ Develops event collateral, including PowerPoint presentations, invitations, speaker bios, speaking points, and follow-up letters as needed.
♣ Oversees freelance writers, designers and photographers in the production of donor communications and newsletters.
♣ Assists with other projects as needed or assigned by manager.
♣ Provides positive and effective customer service that supports departmental and hospital operations.
♣ Contributes to teamwork within and between departments and organizations.

Requirements:
♣ Keen understanding of professional scientific literature and the ability to make difficult concepts accessible to a broad audience.
♣ Experience writing about clinical medicine as well as basic science.
♣ Highly developed presentation, interpersonal, organizational and written communication skills.
♣ Success at collaborating with other professionals - especially fundraising professionals - and producing content that meets their needs.
♣ Ability to manage several projects simultaneously.
♣ A minimum of a bachelor’s degree and five-to-seven years of relevant and progressive professional experience, including exposure to fundraising and working with nonprofit organizations.

The Science Writer will be evaluated on his or her success at:
♣ Producing scientifically accurate writing that makes a compelling case to potential donors.
♣ Producing work that meets the high quality standards of the Communications Department and Major Gifts Officers.
♣ Shepherding work through proper channels.
♣ Meeting deadlines.
♣ Collaborating with other Trust and hospital employees to support the mission of the Trust.

Interested and qualified candidates should send resumes to Scott White (scott@chaloner.com) or Tom Lutzy (tom@chaloner.com).

Sr. Publications Writer for i3 Statprobe - Office- or Home-based Opportunity

Click above for more information.


Medical Writing Specialist - Bayer Healthcare Pharmaceuticals, Montville, NJ


The Medical Writing Specialist is responsible for the tracking, quality control and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents.

Some responsibilities include: • Working together with key interface partners (e.g. Study Management, Statistics and Programming) to facilitate the completion of clinical study reports and their appendices. Using project management skills to track, review and ensure timely completion of high quality regulatory documents • Checking that study file components (e.g., Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements. • Acting as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guides to reflect new agreements and changes due to SOPs and regulatory guidelines. • Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent. • Performing real-time edits to clinical documents during comment review and resolution meetings. • Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation and electronic publishing. • Managing the review and approval of documents in the document management system using standard procedures.

Requirements:
Bachelor’s or Associates degree with strong electronic documentation and word processing skills. Excellence in written and oral communication skills in English. Excellent interpersonal skills. Familiarity with clinical research, statistics, and regulatory submission requirements preferred. www.bayerjobs.com.

Two openings. More information here.

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, G√łtzsche 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, G√łtzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134(8):663-694.
You can learn more about reporting research findings and presenting data by taking the online course Epidemiology and Biostatistics for Medical Writers.

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!

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.

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.

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.