Thursday, March 26, 2009

Monday, March 23, 2009

Telecommuting as a Medical Writer

In the past, many new and aspiring medical writers have asked me about telecommuting: do pharmaceutical companies let you work from home? can you be employed as a medical writer without working on site? 

The answer is always yes, you can, and I have directed them to some other people's experience. Well, now I can talk about my own experience. I left Texas a couple of weeks ago and moved to the Pacific Northwest, but still work for I4PH in Galveston. 

Telecommuting rocks. Oh yes, I love working from home, but it requires certain conditions to be successful:
  • Good time management: With no real office hours and no clock in/clock out requirements, you must be disciplined in setting up your schedule. I start working at 6 am, for example, to make up for the time difference with Texas and to get the most important things done before the kids wake up and start making noise.
  • Family Support: Okay, you are at home and your children want to see you, and your spouse needs some help in the kitchen. Not good. You need your family members who are at home to understand that you are working. If you have a separate room for your office, great--close the door and come back out for lunch time. Until then, you are "away at work." You can be flexible, of course, and take some breaks. But these must be your initiative. In other words, if you just finished one project and want a short break until you begin the next, then go out and share some family time--but don't let interruptions cut your productivity.
  • Focus: It is easy to get distracted when you are at home--and your bed is at hand to take a nap; your favorite snack sitting in the fridge; the TV is on in the next room. You must focus on finishing your projects and not quitting until they're done. In fact, you can set up some rules, like only eating that snack until you finish the first draft of that manuscript. Then, the distractions at home become incentives.
The most important thing, however, is to enjoy your work. If you are miserable doing what you're doing, even if it is from home, you'll be better off going to an office and doing the type of medical writing you are passionate about. 

Thanks for reading and happy telecommuting!

P.S. Not being at the office anymore, it's harder to keep track of the days (at least for me). That's why posts to this blog have been so spaced lately--I just forget because now week days feel like the week end. 

Monday, March 16, 2009

Medical Writing Jobs

These openings are advertised through the Medical Wrting Yahoo group:

From: Stephanie Oscar
The Cambridge Group Ltd.
800-525-3396 ext. 258


I: Medical Writer - 6071
Company: Pharmaceutical Company
Location: Northern NJ, primarily on-site
Status: Long-term consulting engagement
Length: Long-term assignment: initial term 6 months

This NJ-based global pharmaceutical company believes that having the
right people in the right jobs is critical to advancing their action
agenda and becoming a high-performance competitor for the long term. The
company seeks to identify and attract people with superior talent, skills
and winning attitudes. They are creating an environment of continuous
learning and strive to engage colleagues through a unique and inclusive
culture where people are energized, excited and committed to
shared goals and values.

Seeking a contract medical writer to write and QC regulatory submissions,
clinical study reports, investigator brochures and integrated summaries.
Work must be performed primarily on-site.

Requirements: At least 2 years experience in clinical writing for
regulatory submissions including clinical study reports, investigator
brochures and integrated summaries. Advanced degree in Life Sciences,
preferably PhD or PharmD

II: Medical Writer - 6255
Company: Pharmaceutical Company
Location: Northern NJ - on-site
Status: Full-time Consulting Engagement, 40 hours/week
Length: Long-term assignment in 6 month increments

Our client is a company that wants to be recognized for having a positive
impact on people's lives with their products by meeting needs and
surpassing expectations. The company strives to build a reputation for an
exciting workplace in which all employees and contractors can realize
their professional ambitions.

The main objective of this role is project management of clinical report
completion. Responsibilities include: Tracking of reporting status for
Translation Medicine group (Early development- Phase 1 and 2a). Tracking
of key deliverables by cross functional team members. Integration of
clinical information (protocol, amendments, monitoring trip reports and
clinical data) to produce a high quality clinical study report.
Functional liaison between clinical trial team and DOC publishing and/or
DRA operations group. Scope of documents may include IB updates, IND
updates and other key documents as required.

Requirements: Minimum life science degree or equivalent. Higher degree
desirable. Excellent written and oral command of English language. At
least 6 years medical writing experience or other relevant pharma
industry experience combined with scientific and regulatory knowledge,
plus knowledge of the medical writing processes. Expert data
interpretation and presentation skills. Extensive experience with
clinical documentation, formats and publication writing.

* *

The Cambridge Group, Ltd. offers a cafeteria-style, flexible benefits
plan where consultants can choose from:

-Two different Blue Cross Health Plans
-Dental Insurance
-Life Insurance & AD&D
-Long-term Disability
-Paid Holidays
-Up to 4 weeks of Vacation
-Continuing Education Reimbursement up to $5,250 /yr
-Section 529 Tax-Deferred College Savings Plan

We also offer relocation benefits, H-1 visa, and sponsorship for
permanent residency (green card) immediately upon hire as appropriate.

Wednesday, March 11, 2009

He's Not a Medical Writer, She Is...

Usually posts on medical writing blogs don't cause a lot of reaction--but this one apparently has, judging from the number of cross links on different blogs. The issue is the casual observation that there are more female medical writers than male medical writers.

A good point is that the ratio of AMWA members is greater on the female side (see the article here). This is a similar trend I've seen in some other writers associations I'm part of. So, are there really more women medical writers or are women simply more likely to join a professional association?

I don't know and I think it doesn't really matter. If they can write, have the passion and time to do it, then they should just do it. Men too. What do you think?

Monday, March 9, 2009

Free Course at

We are running a huge promotion this week at Sign up for the Two-Course Package "Regulatory Writing + Consumer Health Writing" (already discounted 20%) and get the Epidemiology & Biostatistics course for free. That's a $127 value.

This free course is only offered for 3 days, until midnight (PT) March 11.

Click here now to enroll in this package and claim your free course.

Friday, March 6, 2009

Protecting Your Writing as Valuable Intellectual Property

By Janet Switzer (Guest blogger)

The information products that you develop and sell are valuable properties that should be protected -- in the same way major corporations, big-name publishing brands and celebrity authors protect their intellectual property rights.

Intellectual properties are things like published works, recordings, website content, your brand and your trademark. And part of building an information empire is securing the legal control, ownership and defense of these properties -- from registering your trademark, to recording your copyrights to obtaining releases from other people whose expertise or comments you might include in your products. You may want someday to sell your business, assign the published assets, license your marketing system or simply prevent someone else from using your product name and creating confusion in the marketplace.

A few hours spent protecting these assets is critical.


For info-marketers, authors, entrepreneurs and others who benefit from being published or publicized, the name of any product lines or publication series you might create should be officially registered as your trademark, assuming that the name is eligible to be trademarked. At the very least, you should add the trademark (TM) symbol to the name of your products, then put in fine print on your copyright page the words “[Title of Product] is a trademark of [your name or other owner of the trademark].”

Of course, you should always consult your own attorney before undertaking any legal matter. I can’t ethically or legally advise you on legal matters. But I do want to save you some time and money by directing you to information and resources you can use.

The first place to visit for information on trademarking your brand is the website of the United States Patent and Trademark Office ( where you can perform searches of pending and registered trademarks.

Anytime you register a trademark you have in mind, you and your attorney should conduct an extensive search of the mark in use before filing your trademark application and paying a lot of money. Those searches can run several hundreds dollars per name. But one of the easiest ways to save money in this process is to look up your proposed trademark first at the USPTO website, so you know whether you have a fighting chance of getting it.

When you log on to, look for the word “Trademarks” at the left-hand side of the home page, then click on the “Search” button just below it. You’ll jump over to the next page which is the main search page for the Trademark Electronic Search System (or TESS for short). There you can start your search.

Click on the very first search form option, which is New User Form Search (Basic). If you have an actual tradename in mind, you can simply type that word or phrase into the search window and see if any pre-existing marks exist in the TESS system. If you put your phrase in quotation marks, the system will search for that exact combination of words. If you think there may be trademarks that are similar to yours, you can type in just one of the words and see what comes up.

Here’s what you’ll be looking for: A results page that says, “Sorry, no results were returned for your query.” That’s a good sign because it means your proposed trademark has not been registered or applied for by someone else. But, to be safe, you should always do the search again without the quotation marks to see what IS registered that might be similar. In many cases, your proposed trademark might be so similar to an existing mark that your application will not be approved.

You’ll also need to apply in specific classes of commerce where you are using the trademark or plan to use the mark.

Most writers who are building a freelance business or publishing brand will want to register their trademark in the following classes of commerce:

Class 9 -- Recorded material including audio, video, software, etc.
Class 16 -- Printed materials including books, newsletters and manuals
Class 35 -- Consulting, business management and professional services
Class 41 -- Education and training including live workshops, seminars and more

To obtain registration of a trademark (and the ability to use to R-circle symbol after your trademark, the mark must actually be in use in commerce at the time you apply for registration. If you’re just thinking about a new product line or name, you can file an “Intent to Use” application, then convert it to an “Actual Use” application once you can prove you are indeed using it in commerce.

A good intellectual property attorney can tell you more.


What if you simply want to protect your written material and spoken words from other people who might illegally copy it and include it their work? The United States Library of Congress will register your copyright on virtually any kind of written, recorded, visual or other work you produce.

Their website has so much good information, you should really take a look.

But one thing you should know is that any work you create actually carries a copyright the minute you write it and produce it in a tangible form – that means, printing it, distributing it, publishing it, recording it. However, even though the copyright is established when you produce it, you still need to register the work with the Library of Congress in order to enjoy expanded protection of the copyright.

It costs less than $50 to register copyright on each work, plus you have to submit two copies of the work. It’s always a good idea to add a copyright page to your written materials (or print on the label of any CD) a line that reads:

© 2009 Your Name

In other words, type out the C-circle symbol, followed by the year you produced the work, followed by the owner of the copyright (you, your company, two co-authors, etc.).


Sometimes, you merely want to protect the information you’ve acquired from someone else to include in your product.

If you have a guest expert on your conference call series and you want to record that series and sell the recordings later, have the guest sign a release that allows you to use their name and voice for commercial purposes.

If you want to use a testimonial or endorsement from someone important in your advertising and marketing efforts, be sure to have them sign a release stating they said those words and are allowing you to use them for commercial purposes. Some people will sign this release, some won’t. But it’s always good to have this on file even years later -- especially if the testimonial is so powerful that you’re still using it.

If your business is based outside the United States, check with your own national authorities or a local legal expert about securing trademarks, copyrights and releases.


Janet Switzer is the marketing strategist behind some of the best known celebrity authors in the world: Jack Canfield of The Secret and Chicken Soup for the Soul, One Minute Millionaire author Mark Victor Hansen, personal finance guru David Bach, motivational speaker Les Brown and others. Subscribe to her FREE series of info-marketing special reports here.

* DISCLAIMER: Janet Switzer is not an attorney and is not dispensing legal advice. No information contained herein should be construed as legal advice being given by a legal professional, nor should it be construed as particularly appropriate for your specific circumstances. Additionally, since the above material was written, changes to the law may have occurred. Please consult your own attorney before embarking on any activity that affects your legal rights and obligations.

Tuesday, March 3, 2009

Conflicts of Interest at Harvard

Here we go again with this hot topic. Check out this article in the NYT about the ties of Harvard University with the pharmaceutical industry.

Monday, March 2, 2009

Can Anyone Be a Regulatory Writer?

Knowing that regulatory writing is one of the best-paid venues in medical writing, some people have asked me how to break into this industry. But I always tell them that regulatory writing is not for everyone.

First, you must consider your background. Most regulatory writing positions at pharmaceutical and biotechnology companies require that you have an advanced degree (MD or PhD); some prefer or require experience in a particular therapeutic area. There are exceptions of course, and some CROs may give junior writers opportunities at regulatory writing.
“Our experience is that you need to be a good scientist first, preferably with a degree in the health sciences (pharmacist, pharmacologist, nurse) and then hopefully have a talent for writing,” says Larry Liberti, an experienced regulatory writer at Thomson Scientific. “The latter can be developed but it is rare to be able to train someone in the health sciences on the job.”
Second, you must be detail-oriented and be comfortable working with set guidelines and forms. If you are the creative type who likes to inject some art into your writing, well, you may want to try something else.

As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH.

If the above doesn't appeal to you, there are other venues you can try, such as consumer health writing or even developing Continuing Medical Education materials.

Thanks for reading!