Medical Writing Programs: Are They Worth It?

There is an interesting forum discussion at the Medical Writing Network site, about the value of certain certificate programs versus the master's programs available (particularly the USP program in biomedical writing).

Training, of course, is vital if you want to advance in (or break into) medical writing. As I've explained in this blog before, you should seek training in your weakest areas (either biomedical science or writing, depending on your background).

However, because some areas of medical writing have become so specialized (regulatory writing and CME, for example), it's no longer enough to have knowledge of medicine and good writing skills. Now you need to know the intricacies of regulatory affairs, the regulations for CME courses and other "insider" information.

The question is then, should you enroll in a master's program or can you get away with a certificate?

A few months ago, talking with Dr. Susanna Dodgson (the former director of the Biomedical Writing Program at USP), she told me that students there were spending thousands of dollars in education but not getting a job after graduation. One student said in the forum that she now has a $70k in education-related debt.

What good is spending 30 to 70 thousand dollars in an accredited graduate program and end up with no job whatsoever? There are certificate programs that provide the same knowledge for less money and with potentially better results. And when I say better results, I'm talking about employment.

For instance, Dr. Dodgson offers courses in medical and regulatory writing for a thousand dollars or less, and this is what she will do for you: fix your resume, assign 3 articles in regulatory or marketing writing, work through them with you, publish them in the Medical Journal of Therapeutics Africa (which she edits) and get you a medical writing job.

Not even AMWA certificate programs will do that. (Disclaimer: I don't receive any profit for promoting Dr. Dodgson's courses, this is just an FYI)

Johanna Lackner-Marx is doing something similar with her CME coaching program, developing an internship, and helping students set up their own freelance businesses. This is an excerpt from an article by Johanna:

To enable writers to get the experience they need in order to be competitive in the CME market, I am developing a pilot program that places participants of the coaching program with medical writing companies in an internship situation. This program will be launched in early 2009. I shared my plan for this program with Dr. Overstreet. She told me, “This is an excellent idea. It’s a win-win. I anticipate education companies will line up for this opportunity. They get extra help, and writers get real experience they can put on their resume and a chance to make connections in the industry.”

There may be other reasons (and benefits) to get into a graduate program, such as personal gratification, seeking a better pay for having a higher level of education, etc. but, realistically, not every person can afford or take the time to enroll in a master's program.

What do you think? Why would you choose a master's over a certificate or vice versa?

P.S. MedicalWritingTraining.com also offers a basic course on regulatory writing that, although it doesn't give you a resume critique or a job offer, it teaches you the basic information you need to break into regulatory writing, for an affordable tuition. In fact, someone from the USP program told me after seeing the contents of the course: "Wow, $197 and they learn all that! That costs students 13K at USP. Gosh!"

P.P.S. Almost a year ago, a guest blogger and USP student posted this positive article about the USP online program.

Managerial Medical Writing Jobs

• Manager/Senior Manager, Medical Writing -- Elan Pharmaceuticals, South San Francisco, CA
• Manager, Medical Writing -- Nektar Therapeutics, San Carlos, CA
• Manager, Medical Writing and Scientific Communications -- UnitedHealth Group, Ann Arbor, MI
  

Virtual Medical Writing Job

Virtual Medical/Scientific Writer -- NovaBay Pharmaceuticals, Inc.

Some New AMWA Stuff

There are a few items in the latest "AMWA Update" newsletter that I would like to share with those of you who don't receive it:

FIRST WEBINAR FOR 2009
AWMA is pleased to announce JoAnn Hackos, PhD, will be presenting our first webinar of 2009: "Surviving and Thriving in a Flat World." This hour-long event will take place Thursday, February 5, 2009, from 2:00 PM to 3:00 PM Eastern Time. The cost is $50 (US) for AMWA members, $150 for nonmembers—a great opportunity for career development at an affordable price!

NEW “ABOUT MEDICAL COMMUNICATION” SECTION ADDED TO
AMWA WEB SITE
Check out the new "About Medical Communication" section just added to the AMWA Web site; you can find the link on AMWA's home page. The new section offers information about the profession (what medical communicators do, where they work, what they earn), academic programs in medical communication, and advice for breaking into the field.

Thanks for reading!

CME Teleseminar Q&A (Part II)

By Johanna Lackner-Marx, MPH, MSW

Do medical writers generally choose a particular path such as regulatory or CME writing and stick with it or do they sometimes "cross genres"?

Most writers I know specialize in one or two areas of medical writing but crossing over is not unheard of. Most writers either focus on clinical writing (regulatory, clinical trial reports) or consumer health writing (articles, marketing, etc.). CME is somewhere in the middle - it doesn't require the background a regulatory writer has, but one has to be familiar with a lot of the rules and regulations that shape CME. In my experience writers may start as generalists, but eventually realize that they need to specialize either in the type of writing they do (for example, in regulatory, consumer, or CME writing) or in specific health areas (cardiology, neurology, etc.). Those writers who have developed a profitable business in either regulatory writing or CME do not tend ‘cross genres’. It takes focus, dedication, persistence and some business acumen to become successful in medical writing and when one hits it, one tends to stay where the work is.


If I choose to focus on CME writing as a medical writer, should I write pediatric CME material (my specialty) or can I branch out?

I tell all my clients to first build on their strengths. Your strengths are your pediatric expertise and your experience and credential as a nurse. There is work specifically for nurses who know how to do CME. Since nurses must take a certain number of continuing education credits, you could immediately specialize in education for nurses.


For now, I plan to continue working as a practitioner. Will it be more difficult for me to begin my medical writing career as a freelancer?

Most freelancers continue a ‘day job’ until they build up a large enough clientele to meet their financial goals. The difficult comes when you are on deadline and the amount of work you have surpasses the time you have to do it in (after the time you must devote to your regular job, family, etc.). It is possible to start slowly with one job at a time and to look for work that has longer turn-around requirements. In addition, your continued work as a practitioner can act in your favor and can be used as marketing strategy. As a practitioner you are in the field and more up in touch with the clinical side of your profession than writers who write from a distance.

Generally, are the standards for writing continuing education materials for other licensed professionals such as for respiratory therapists or mental health counselors as rigorous as for the medical community?

Of the licensed professions for which I have created CME, the most rigorous and regulated are physicians, physician assistants, nurses, and physical therapists. For the most part what makes CME for these professions different is the number of regulations that have been put in place to create a firewall between the bias that can be introduced by commercial interests and the educational content. The purpose of these regulations is to ensure independent content development and dissemination. All the other helping professions that are licensed and require continuing education are less regulated. However, in my opinion, the guidelines encompassing accredited medical education are gold standards. If you know how to do CME for these more regulated professions, you can create continuing education for the other groups – you just have to learn what their standards are. In most cases, they will be less stringent than the standards for CME.

Are there opportunities for writing continuing education materials for health professionals other than NPs or PAs?

Yes! Any licensed health profession that requires periodic reaccreditation, uses continuing education as a qualification. The information I provide in my course will be directly applicable to continuing education for these health professions. Continuing education for nurses and physician assistants mimics CME in terms of regulation. In fact, nurses and physician assistants are allowed to take CME for credit.

A Word About Johanna's Program
For those who are interested in taking the Advanced Coaching in CME for Medical Writers, they will receive a lot of useful information about how to use their skill set to create a niche for themselves. How to market oneself is also covered. In one-to-one sessions she will act as a guide and will help each learner create a strategic plan of action.

CME Teleseminar Q&A (Part I)

By Johanna Lackner-Marx, MPH, MSW

Below are the answers to some questions we received after the December 4th teleseminar, "What Every Medical Writer Should Know About Developing Continuing Medical Education (CME) Materials."


“How do you think the newest Pharma guidelines and CME guidelines will impact the CME market?”

This is the question that has been asked by all stakeholders over the past year and there continues to be a lot of speculation in the industry on what final impact the new guidelines will have on the CME market. There is no doubt in anyone’s mind that CME is here to stay. The question is how will CME be funded.

Some proponents feel that commercial support should be eliminated from CME altogether. Some state physicians should pay more for CME credit, eliminating the need for commercial funding. Others believe there should be a central pot into which Pharma deposits grant monies which could then be distributed for CME by an independent entity.

At this time there is no consensus and Pharma continues to fund CME.

“Since Pharma can no longer even suggest a topic for CME, do you think they will stop funding these programs?”

I believe that Pharma will keep funding CME unless a law or regulation is passed prohibiting their sponsorship. Although there is a lot of discussion about the role commercial support should play in CME, at this time there are no laws preventing Pharma from continuing to sponsor CME.

Pharma’s motivation has always been to bring their products to the attention of physicians and to make sure physicians understand their use. Sponsorship has been an important marketing strategy for them.

It is important to note that the Accrediting Council for Continuing Medical Education (ACCME) has always maintained that there be a ‘firewall’ between the commercial supporters of CME and the actual educational content of CME. So, the edict that Pharma should not to be allowed to suggest topics for CME is nothing new.

How this could affect CME medical writers? As long as CME is required for re- licensure, there will be work for CME medical writers. Whether or not commercial funding is allowed or not is primarily a funding issue. Even if commercial support is eliminated from CME altogether,
CME must still be created.

"I work with medical and scientific information daily, however, I do not hold an advanced degree in the sciences or English and generally find that I have the knowledge to understand basic concepts and then need to research details. In your opinion, would I have sufficient background and knowledge at this stage to successfully create CME-related products?"

Most medical writers do have an advanced degree in some science or health related field. Some also specialize in particular health areas, such as cardiology or neurology, etc. However, many writers have a strong foundation in biology or human physiology and are generalists. Whether specialists or generalists, most writers have to do some amount of research on topics they write about and have to know the rules and regulations pertaining to CME.

A basic grounding in biology and human physiology is adequate to create CME. CME differs from scientific medical writing in that often one is hired to prepare documents related to the content but the content is created by someone else. For example, I was hired to write a required report called a Needs Assessment which summarized current literature validating the need for a CME program on a specific medical topic. The program content, however, was written by others with more expertise in the program topic.

There are three qualifications clients review when choosing a medical writer to create any CME-related product.

1. Education – advanced degrees
2. Training - instruction in medical writing in general and CME in particular
3. Experience – a history of creating CME and/or CME related projects, i.e. a portfolio and roster of past clients

In your case, you have an advanced degree in Medical and Biological Illustration – a master’s that provided what sounds like a basic foundation in physiology and biology. This could satisfy your education qualification. What you are lacking is the training in CME and the experience.

I believe my course could give you the training in CME you need. You will get instruction in CME with a focus on what medical writers need to know.

As far as experience goes, you may be interested to learn that I am in the process of creating an internship program for medical writers which places them, either on site or virtually, with medical education companies. It is my hope to provide writers who are trying to break into the CME field with real experience from which they can learn and that they can note on their resumes along with testimonials they might receive for their work. I hope to launch this program in early 2009. I am also in discussion with other parties about creating a freelance company where graduates of my training can be listed along with their three types of qualification. (It has not yet been decided if the internship program and listing opportunity will be available to all participants or just graduates of the advanced coaching program.)

In summary - yes, I believe if you get some additional training in CME and acquire some relevant experience, you could get work as a freelancer or as an employee.

"I need help deciding which course to choose."

Here are some pointers to help you decide:

You should choose the Basic (Silver) course if:

• You want to get a good idea what CME is all about.
• You want to find out whether becoming a CME specialist is a good choice for you.

You should choose the Advanced (Gold) course if:

• You want to have another skill set in your medical writing ‘tool box’
• You want to do freelance work on CME projects

You should choose the Coaching (Platinum) course if:

• You seriously want to start your own CME medical writing business
• You want one-on-one support
• You want free templates for CME documents and forms
• You want a database of CME companies
• You want to keep up-to-date on what is happening in the industry.
• You want to have the option of working freelance orapplying for permanent positions in the CME industry.
• You want to begin preparing for certification.

"I want to take the Platinum course, but won't have money until January. Will you still offer the templates, etc. at that time?"

Yes, we will continue to offer the templates and the other bonuses as part of the Platinum program in January and afterward.

However, if the first 30 spots are taken before you sign up, you would have to enter a waiting list for the next Platinum level group.

For more details on the Platinum course, click here.

Happiness is Contagious

Check out this interesting (and jolly) epidemiological study published in the British Medical Journal, Dynamic spread of happiness in a large social network: longitudinal analysis over 20 years in the Framingham Heart Study.

The New Certified Continuing Medical Education Professional Credential: Do Medical Writers Need It?

By Johanna Lackner-Marx, MPH, MSW (Guest blogger)

New CME Credentialing Program Launched

Next to regulatory writing, almost nothing seems as daunting to medical writers as continuing medical education (CME). CME has become so specialized that those who work in the CME industry often appear to carry the mystique of highly trained trapeze artists who pass on their unique expertise only to other acolytes entering the field of CME.

When the first credential exclusively for CME professionals was unveiled this fall, many medical writers wondered if they should consider earning the new Certified Continuing Medical Education Professional (CCMEP) designation as a way to gain entrée into CME. The certification was created by the National Commission for Certification of CME Professionals (NC-CME), a independent, non-profit organization created in 2006 by leaders in the CME industry. The NC-CME developed the certification as a standard of competence for persons who create, deliver, or support CME programs for the more than 700,000 physicians in the United States who must take CME to maintain their licensure.


Government Scrutiny Spurs Industry Improvements

The certification will be used by organizations to demonstrate the knowledge and skills of CME staff and to validate the integrity of their education programs to the government, public, and media. This initiative comes in the wake of an investigation by the Senate Finance Committee into allegations of bias stemming from the promotion of unapproved (“off-label”) use medications marketed by the very companies that provided grants to support CME. The Committee found that “…Press reports and documents exposed in litigation and enforcement actions confirm [the allegations] in some instances. There is also evidence from ACCME [the Accrediting Council for Continuing Medical Education that accredits CME providers] that some accredited CME providers still allow commercial sponsors to exert improper influence on educational activities that are supposed to be independent from commercial interests.”


Should Medical Writers Take the CCMEP Test?

Karen Overstreet, EdD, RPh, FACME, CCMEP, president of Indicia Medical Education, LLC, does not believe medical writers need to obtain certification. Overstreet chaired the test-development committee and is now president-elect of NC-CME. “Medical writers make a tremendous contribution to CME. They are the creators of the majority of educational content and their role will remain the same as it is now - developing evidence-based, relevant content and validating it. The test is targeted toward professionals responsible for the creation, administration and implementation of CME or strategic planning and policy development for CME organization.” The professionals Overstreet is referring to include directors of CME departments, senior level management of medical education companies and other provider organizations, and individuals in the pharmaceutical industry who are involved in grant administration.

The test covers principles of adult learning, administration and management of CME, accreditation requirements for providers of CME, and the regulations and guidelines mandated by the multiple government agencies and organizations created to ensure CME is independent and unbiased. “I think it would be unusual for a medical writer to pass the exam unless she had very broad knowledge of topics relevant to the creation, administration and implementation of CME”, Overstreet states.

Besides a comprehensive understanding of CME, medical writers who want to take the certification test must jump another hurdle. Only professionals who meet specific eligibility criteria can apply to take the test. Those seeking the credential must first submit a form summarizing their education, continuing education work experience, and professional development activities. Each element is assigned a point value and only those with the requisite point total are admitted to the exam. “The point of the certification is to document experience and skills, and one must have considerable experience to be considered a ‘CME Professional’.” says Overstreet.


Advice for Medical Writers Interested in CME

The path to CME writing through certification appears to be an arduous and time consuming one and according to Overstreet, not really necessary for medical writers. “But there definitely are specific skills and knowledge that would help medical writers stand out to a CME employer.” These include knowledge of adult learning principles and instructional design, how to make content engaging, and an understanding of how to comply with CME guidelines and regulations.

In addition, Overstreet recommends that writers try to get hands on experience with CME so they can build their resume. The question remains, however, if writers new to CME will be able to find work. According to Overstreet, with pressure from a tightening economy, medical education companies are more likely to assign work to internal staff than to farm it out to freelancers. “When we do contract with freelance writers, we select those we have a history with and who have prior experience in CME.”

New Training Program for Medical Writers Offers Experience Launches in 2009

In January 2009 a new training program will be available specifically for medical writers interested in CME. My name is Johanna Lackner-Marx, MPH, MSW. I am medical writer, like you, and a CME consultant. I created this training program because I recognize the dilemma facing writers trying to enter the CME industry. The program, Becoming a CME Specialist, will be launched on Diego’s website, MedicalWritingTraining.com. The program offers content designed to provide the knowledge, skills, and experience writers need to enter the CME industry.

Becoming a CME Specialist is offered at three distinct levels of training that can be taken independently of each other depending on your goals. The basic and intermediate courses are designed to teach the fundamentals of CME with varying degrees of depth, allowing medical writers to determine if CME is right for them and adding to their professional tool box. A third course goes beyond this, providing one-to-one coaching and resources that will be helpful to those who want to start their own CME freelance business.

Coaching Program to Offer Hands on Experience

To enable writers to get the experience they need in order to be competitive in the CME market, I am developing a pilot program that places participants of the coaching program with medical writing companies in an internship situation. This program will be launched in early 2009. I shared my plan for this program with Dr. Overstreet. She told me, “This is an excellent idea. It’s a win-win. I anticipate education companies will line up for this opportunity. They get extra help, and writers get real experience they can put on their resume and a chance to make connections in the industry.”

I look forward to working with any of you who are interested and welcome suggestions to incorporate into the course. You can send questions or suggestions directly to me (johannalackner@inquill.com). I will respond to you personally and Diego will also post the question and answer on this site.


Click here for more information about the courses.

How Much Do CME Specialists Make?

During our teleseminar last week with CME consultant and medical writer, Johanna Lackner-Marx, we learned that freelance medical writers may charge between $60 and $120 per hour for a Continuing Medical Education (CME) project. According to SimplyHired.com, the average salary for CME Specialist jobs is $94,000.

Unfortunately, many medical writers don't know about CME or are not prepared to tap into this area of medical writing. Click here to listen to the recording of the teleseminar and learn more about how you can become a CME specialist.

Medical Writing Job Openings

• Senior Associate Director -- Ridgefield, Connecticut
• Senior Medical Writer -- Switzerland
  

Webinar: Graduate Programs in Biomedical Writing

Tuesday, December 9 at 8:00PM EST - free live webinar, Graduate Programs in Biomedical Writing: Your path to a successful career.

For people interested in pursuing a certificate or master's degree in biomedical writing, as well as those who may want to just take coursework for professional development are encouraged to attend. Dan Benau, Program Director of University of the Sciences in Philadelphia's graduate programs in Biomedical writing will discuss:

• Introduction to the Program
• Online Course Software
• Teaching Methods

Medical Writing in India

As announced a few days ago, we have released Becoming a Medical Writer (Indian Edition) with lots of great information for medical writers in India.

Starting today, and until January 31st, 2009, there's a special introductory offer for the ebook. We reduced the price almost $10. Click here to read more about the ebook.

Medical Writing Positions

• Offsite Medical Writer -- Palm Harbor, FL, Charlotte, NC, San Francisco, CA or work remotely from home office

• Thorburn Geiger, a Management Consultancy specialised in ExecutiveSearch is currently looking for a Medical Writer for a client, a bone manufacturer. The position will either be based in Boston, US, or in London, UK. Contact Helen Detraz, helen@thorburngeiger.com

• Medical Writer -- Thousand Oaks, CA

The ideal candidate will have a clinical background and solid
experience in publications and abstract writing.

Doctorate level degree (PharmD, MD, PhD) with 3+ years Medical
Affairs experience or Master's with 4+ years of related experience.

Work in cross-functional teams in a dynamic environment across the
organization. Ability to write and present on scientific and
clinical issues. Excellent communication (written and verbal),
interpersonal, organizational and project planning skills and can
work effectively in a team/matrix environment. Knowledge and
understanding of relevant clinical and therapeutic issues required.

Reporting to the Medical Communications Director, this person will be
a team member of the Medical Communications team. The team is
responsible for the creation of tools and materials for the
therapeutic area. The candidate will be responsible for providing
high quality and high impact support of Regional Medical Liaisons,
the sales and marketing team, Global Health Economics and Outcomes
Research. The daily activities for this position include but are not
limited to developing and executing clinical and scientific
communications, education, training resources, developing programs
and materials for internal and external customers, and providing
clinical support of key scientific congresses and meetings.
Candidate should also demonstrate working knowledge of legal and
regulatory guidelines in the pharmaceutical industry.

Some travel required; typically 20% and occasionally up to 25%.

Contact: Jackie Bandish
Principal and VP of Recruitment
Clinical and Medical Affairs Division
(O) 215-444-9002 or 800-881-9976
jackie@bandishgroup .com
www.bandishgroup. com

Becoming a Medical Writer (Indian Edition) – What’s in There?

By Natasha Das (Guest blogger)

The medical writing market in India has certain unique features. Here’s just one example. Many of the medical writers in the US and other countries have their highest educational qualifications in the humanities. However, it is hard to find a medical writer in India who is not a science graduate. Almost three quarters of the medical writers here are physicians or dentists, according to an online survey I conducted in October 2008. Part of the results was presented during AMWA’s Open session 32 – Medical Writing outside the US: Challenges and Opportunities on Sat, Oct 25th, 2008.

Each week, I receive several queries from people wanting to know more about the medical writing field. Many of these inquiries come from people who usually fall into one of the following categories:

• People wondering what medical writing is all about
• Medical doctors wanting to become writers
• Non-medicos knowing they have a flair for writing and wanting to break into health or medical writing
• People looking for medical writing courses, and graduates and certificate programs
• Graduates looking for medical writing jobs
• Medical writers wanting to start freelancing and are wondering what they should charge
• Experienced medical writers planning to move to India but are unsure of their career prospects here

If you think you fall into any of these categories, then the ebook Becoming a Medical Writer (Indian Edition) coauthored by Diego Pineda and me is just the one for you.

The Indian edition of the book answers these and many more questions. Like the How to become a Medical Writer Self-Study Guide I wrote and the earlier edition of the ebook Becoming a Medical Writer that Diego wrote, this book also talks about what medical writing encompasses, its different types, the qualification and skills needed, and the training available. It also tells you where and how to look for jobs and how to kick-start your freelance medical writing career. In addition, Becoming a Medical Writer (Indian Edition) is prepared keeping the medical writer in India in mind. The Indian edition brings you:

• Excerpts from the results of the first ever documented survey of Indian medical writers
• Experiences of several medical writers (many of whom are from India) in their own words
• Best training, and graduate and certificate courses available in India and abroad
• Online training courses and whom to contact
• Recruiters in India that look for medical writers
• List of companies in India which hire medical writers
• Salaries of medical writers in India
• Rates that freelance medical writers in India charge
• 24 professional organizations around the world ( 4 of them Indian) that offer networking, educational and career advancement opportunities
• An introduction to All India Medical Writers Association (AIMWA) and its activities
• Online communities of medical writers on orkut and ning where you can interact directly with other medical writers from India

We hope you will enjoy reading the book and it will guide you during your first steps into the exciting and lucrative career of medical writing in India!

Click here to order Becoming a Medical Writer Indian Edition.

Teleseminar "Sold Out"

There has been a great response about this Thursday's teleseminar, What Every Medical Writer Should Know About Developing Continuing Medical Education Materials. So much that I had to close registration because the service provider won't allow me to have more than a certain number of lines.

If you were not able to register but still want to listen to this call, be sure to sign up for my mailing list (you can do it on the right-hand menu of this blog) so I can notify you when a recording becomes available.

Thanks for reading!

Medical Writing Jobs

• Director of Medical Writing, Transatlantic Management Opportunity -- England

• Scientific Grant Writer: The Texas Heart Institute (Texas Medical Center, Houston) is seeking qualified applicants for the position of Scientific Grant Writer. The Scientific Grant Writer will be responsible for identifying sponsored research opportunities, coordinating all aspects of grant applications, assisting staff in writing and editing grant applications (including contributing to the presentation of the scientific protocol and research plan), and following up with granting agencies to ensure the highest probability of funding. Minimum requirements include a master's degree in a biomedical or science field, research grant writing experience, and demonstrated writing and editing skills. To discuss or to apply, please contact Marianne Mallia, ELS, via e-mail at mmallia@heart.thi.tmc.edu or telephone at 832-355-6776.