Monday, December 29, 2008

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.

Wednesday, December 17, 2008

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.

Tuesday, December 16, 2008

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.

Monday, December 15, 2008

Thursday, December 11, 2008

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.

Wednesday, December 10, 2008

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.

Monday, December 8, 2008

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.

Friday, December 5, 2008

Medical Writing Positions

  • 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

Tuesday, December 2, 2008

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!

Monday, December 1, 2008

Medical Writing Jobs


  • 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.

Thursday, November 20, 2008

Free Teleseminar on Developing CME Materials

As announced before, I'm preparing a free telephone seminar for Thursday, December 4:

"What Every Medical Writer Should Know About Developing Continuing Medical Education (CME) Materials"

Click here to read more about the teleseminar and to register for it.

Wednesday, November 19, 2008

Two Regulatory Writing Positions

A recruiter contacted me about open positions at VinCro Clinical Management Services, a full-service CRO that specializes in the management and placement of contract clinical staffing personnel. They are seeking contract Sr Medical Writers and Medical Editors with diabetes experience immediately. See below for details.

Title: Senior Medical Writer


Location: Northern NJ (3 days on-site, 2 days off-site/home office) (Near Hackensack)

Job Purpose: We are seeking a senior level medical writer to support Phase 1 / Pharmacokinetic studies involving diabetes. This is a full-time 3 month contract position with possibility of renewal based on candidate performance and company need.

Key Responsibilities:

1) Discuss, develop, produce, revise and/or update protocols and clinical study reports for preclinical and clinical studies

2) Responsible for developing IB's, components of Investigational New Drug, Clinical Trial Authorization, New Drug Application submissions, regulatory responses, and other clinical/regulatory documents.

3) Provide support to the assigned clinical development team to ensure clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines.

4) Mentor and train junior medical writers as required

5) Manage outside contractors as required

6) Facilitate conflict resolution across multi-disciplinary teams


Requirements

Minimum Bachelor's degree (BSN/MS/PhD/PharmD preferred) required in biological, nursing or medical sciences

5+ years of relevant medical writing experience including protocol writing

Project Management experience with a strong track record of planning and organizational skills with minimal supervision

Experience in pharmaceutical industry Phase I-II pharmacokinetic/pharmacodynamic research is required

Knowledge of the development, regulatory, quality, and compliance environment within the pharmaceutical and marketing environment

Strong interpersonal and communication skills

Familiarity with ICH and AMA guidelines

Proficiency in MSWord, Excel, and PowerPoint


Compensation: $85-100 per hour. Reasonable travel expenses will be reimbursed.



Title: Medical Editor

Location: NJ (3 days on-site, 2 days off-site/home office) (Near Hackensack)

Job Purpose: We are seeking a medical editor to proofread and edit research protocols, clinical study reports, medical writing templates as well as check IB’s, IND, CTA, NDA, regulatory responses and other clinical/regulatory documents for accuracy and flow. This is a full-time 3 month contract position.

Key Responsibilities:

1) Responsible for medical, technical and traditional editing and proofreading by ensuring correct grammar, spelling, and typography of approved documents

2) Preparation of medical writing templates

3) Proofread and edit protocols and clinical study reports for preclinical and clinical studies; Investigator’s Brochures; components of Investigational New Drug Applications, Clinical Trial Authorization, and New Drug Application submissions; regulatory responses; and other clinical/regulatory documents

4) Provide editorial support to the assigned clinical development team to ensure that clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines

5) May supervise and manage medical editing consultants in the absence of or as directed by Senior Manager, Medical Writing or Senior Director, Medical Writing


Requirements

Minimum Bachelor’s Degree in Communication, Physical Sciences, Medical Sciences, advanced degree an asset

2 years of pharmaceutical industry experience in regulatory, medical writing or clinical development arenas

Strong interpersonal and communication skills

Familiarity with eCTD, ICH and AMA guidelines

Proficiency in MSWord, Excel, and PowerPoint


Compensation

$45-65 per hour. Reasonable travel expenses will be reimbursed.


If interested, contact:

Shawn Varrin, M.Sc., M.B.A.
President
VinCro Clinical Management Services
6813 Sunset Blvd.,
Ottawa, Ontario, Canada
K4P 1M6
Ph - 613-526-4267
Fax 613-526-6200
Email: svarrin@vincro.com

Monday, November 17, 2008

Consumer Health Writing Course Expanded

After the good response I've had from my risk communication talks, I've decided to include a risk communication primer into the Consumer Health Writing Course offered at MedicalWritingTraining.com.

Not only have I added a week's worth of study material but have thrown in a couple of new bonuses for students. The new material will, of course, drive the price up. But you can sign up for the expanded course at the old price until November 21, 2008. Tuition will increase this Friday night.

Friday, November 14, 2008

Coming Up in December

I have some exciting stuff on the making. First, I've been working with Indian medical writer Natasha Das to create the Indian version of my ebook, Becoming a Medical Writer. It has all the same information one needs to break into medical writing included in the original version, but with emphasis in the Indian market: rates, employers, CROs, professional organizations, and more. We will release the ebook in the next few weeks.

Second, I'm going to offer a FREE teleseminar on December 4, about developing CME materials. I'm going to have an expert on the call that will give you tons of information and guidelines for this type of medical writing.

Sign up for updates on this blog so you won't miss the details for this teleseminar.

Thursday, November 13, 2008

Medical Writing Salaries By Region

I've had a couple of questions this week about salary ranges in specific areas of the United States. Obviously, if you're looking for or have been offered a position, you would want to know how much other medical writers in your region are earning.

Here's what I found in the 2007 AMWA Salary Survey regarding salaries by region:

Outside US and Canada: Mean, $88,809. Median, $92,000.

NY, PA, NJ, DE, Eastern Canada: Mean, $90,744. Median, $83,000.

AK, WA, OR, CA, HI, Western Canada: Mean, $91,537. Median, $84,000.

MA, CT, RI, VT, NH, ME: Mean, $83,670. Median, $85,000

WI, MI, OH, IN, IL: Mean, $78,044. Median, $76,000.

KY,TN, NC, VA, WV, MD, DC: Mean, $73,317. Median, $68,000.

ND, SD, NE, MN, IA: Mean, $76,331. Median, $71,000.

AL, MS, GA, FL, SC: Mean, $71,658. Median, $65,000.

KA, OK, TX, MO, AR, LA: Mean, $66,856. Median, $63,500.

ID, MT, WY, NV, UT, CO, AZ, NM: Mean, 61,298. Median, $58,000.

Wednesday, November 12, 2008

More About Developing CME Materials

I'm planning a new course for medical writers who want to learn how to develop CME material. Hopefully, we will release it soon. For now, here's an article from a guest blogger that explains why physicians need CMEs.

How Can Continuing Medical Education Credits Be Obtained?
by Li Ming Wong (Guest blogger)

While physicians spend many, many years in school prior to receiving their MD, it is impossible for them to learn everything there is to know. The medical field is simply too vast, and it is constantly in motion; therefore, it is important that every physician complete continuing medical education. Continuing medical education (CME) allows a physician to stay abreast of new discoveries, treatments, and other advancements in their chosen field.

What worked thirty years ago is not usually the method of choice for today's physicians, and clinicians who do not complete these continuing education credits may often be placing their patients at risk because of a lack of knowledge of treatments that have been deemed ineffective or hazardous. Unfortunately, often when a physician is wrong it is the patient's life that pays the price.

Due to this, every physician is required to complete a minimum number of CME credits every year; however, they are certainly not required to stop once that number is met. This does not necessarily mean returning to school, although this is certainly an option; however, for most physicians caring for their patients leaves them little time for the heavy workload of a secondary education institution. Many other more convenient options are available to them.

Across the nation hundreds of thousands of medical conventions, symposiums, workshops and conferences are available to healthcare professionals, covering topics from new surgical techniques to treat collapsed heart valves to the use of stem cells to treat congestive heart failure; all cutting edge technology not yet taught in the classroom. These often take place over the course of a weekend, often last more than one day and are held in various locations, so physicians from any location in the country may attend at their discretion. In many rural areas there is only one doctor available, often with no one to see to their patients when they are unavailable. These are the physicians who are still on call twenty four hours a day, make their own hospital rounds and see patients from birth to death for everything from a toothache to a heart attack. Needless to say they are often unable to get away from their practice to attend weekend workshops.

Another option is available for them so they can continue to provide their patients with around the clock care. The internet has opened up a whole new world to the field of continuing education.

Many organizations, such as the American Medical Association (AMA) and the American Association for Continuing Medical Education (AACME) offer resources online for healthcare workers to complete their continuing medical education credits. Here clinicians will have the opportunity to complete coursework online, view online conferences and use the teleweb to attend lectures and symposiums.

These CME resources may be found free of charge or for a small fee per credit hour, depending on the situation; however, this is infinitely less expensive (and time consuming) than returning to a college or university, and offer greater benefits because attendees are able to stay apprised of new research and untried methods that are not taught to students. It is true that no one ever stops learning, and this is especially true in the medical field.

Continuing medical education allows clinicians to stay on top of their field and provide the best, most advanced care options available to their patients.

Monday, November 10, 2008

Medical Communications Positions


Communications/Public Affairs Officer -- Infectious Diseases Society of America

The Infectious Diseases Society of America (IDSA) has an opening for a communications/public affairs officer who will develop and implement communications initiatives to raise awareness about the Society and its goals among various audiences--including members, potential members, policymakers and other advocacy groups. The person’s primary responsibilities will be to write and edit two monthly electronic newsletters for IDSA and the HIV Medicine Association of IDSA. In addition, the person will serve as a primary point of contact for reporters, and will write press releases and coordinate interviews with physician spokespersons. The person will also be responsible for writing and editing other publications, brochures, speeches and talking points.

The ideal candidate will have a degree in journalism, English, public relations or a related field, and three or more years of progressive communications experience, including significant writing/editing experience and knowledge of publications processes.

Excellent benefit package (medical, dental and 401k), and a friendly, exciting, professional, Metro-accessible work environment in Arlington, Va. Please send cover letter and resume to:

Diana Olson
Director of Communications
Infectious Diseases Society of America
1300 Wilson Blvd., Suite 300
Arlington, VA 22209
dolson@idsociety.org
www.idsociety.org and www.hivma.org.

Friday, November 7, 2008

CME and Medical Writing

Here in the US, many states require physicians to earn educational credits every year to maintain their professional license. These credits are earned through continuing medical education (CME) courses.

Writing the content of CME courses for health care professionals is a lucrative opportunity for medical writers. The purpose of CME courses or materials is to update the medical community with the latest information on medical treatment, patient care, and other topics. CME content is delivered in many different formats, from self-study guides and monographs about a particular disease to multimedia presentations and educational videos.

Medical education is also directed to patients, who need accurate and reliable information to make decisions about their health. As a writer in this field, you would write patient education materials such as brochures explaining how to take a medication or how to cope with a disease, Web site articles, and video scripts.

Some medical communications agencies specialize in producing CME and patient education materials and they usually have medical writers on staff. You may also do this kind of writing at universities or medical schools, which often have a CME office.

Tuesday, November 4, 2008

New Medical Writing Resources

At the AMWA conference, I became aware of a couple of little books for medical writers and since then have the opportunity to read some excerpts.

One is THE ACCIDENTAL MEDICAL WRITER: How We Became Successful Freelance Medical Writers. How You Can, Too by Brian Bass and Cynthia Landis Kryder. In this book, the authors describe their unique career paths into medical writing and provide some tips and lessons for aspiring freelancers. From what I've read so far, it seems like a nice motivational reading but lacks real hard advice on entering the profession.

The second is a booklet with a very promising title, Are you Thinking of a Career in Regulatory Medical Writing? A “How-to” Guide on Getting Started. However, the information is very general and there's no practical info about how to actually do regulatory writing.

Finally, I'm offering two-course packages at 20% off at Medical Writing Training.com.

Thursday, October 30, 2008

Risk Communication Talk at AMWA Conference

I had a little over 20 people listen to me talking about risk communication during an AMWA open session last Friday. We had a nice discussion of the challenges we face as risk communicators, especially with the public's mistrust of the medical community.

Anyway, I want to share the slides of my presentation with you also. Click here to view the PDF.

Thanks for reading!

Wednesday, October 29, 2008

Consumer Health Writing in the NYT

The most e-mailed article at the nytimes.com as of Wednesday morning is a consumer health piece titled, "A Rise in Kidney Stones Is Seen in U.S. Children."

Of course this is a topic of great concern to parents and kidney stones in children should be discussed in the media, to increase awareness. What troubles me about the article (especially the headline) is the lack of data. The author herself acknowledges this in the second paragraph:
While there are no reliable data on the number of cases, pediatric urologists and nephrologists across the country say they are seeing a steep rise in young patients. Some hospitals have opened pediatric kidney stone clinics.

“The older doctors would say in the ’70s and ’80s, they’d see a kid with a stone once every few months,” said Dr. Caleb P. Nelson, a urology instructor at Harvard Medical School who is co-director of the new kidney stone center at Children’s Hospital Boston. “Now we see kids once a week or less.”
But is this anecdote from the Harvard doctor enough to claim a rise in kidney stones in US children? No. I'm not saying that the increase is not real, it may as well be real. But responsible medical writing should be evidence-based, and the matter-of-factly tone of the article has probably caused a lot of concern among NYT readers.

BTW, a quick search in PubMed for "kidney stones AND children" and "renal calculi AND children" brings up thousands of articles. From the abstracts I read, it seems that kidney stones are still considered rare in children. Interesting...

Tuesday, October 21, 2008

Blog Recommendation and See-You-Later Note

You know my rambling about the importance of epidemiology and biostatistics in medical writing. Well, there's a great epidemiology blog you might want to check out at epiwonk.com.

I'm leaving tomorrow morning for the AMWA conference. So, if you're going too, I'll see you there. If not, I'll be back posting to the blog next week.

Thanks for reading!

Monday, October 20, 2008

Regulatory Writing: NDAs & INDs

Some new medical writers interested in regulatory writing ask about the difference between NDAs and INDs. In simple terms, when a drug is determined to be safe and effective, the manufacturer files a New Drug Application (NDA) with the FDA at completion of the clinical trials.

However, before the drug is approved, it has to be tested and shipped to other investigators. But how can the researchers use a drug not yet approved by the FDA? The answer is the Investigational Drug Application (IND), which allows an unapproved drug to be used in certain circumstances (there are different types of INDs, depending on the need).

Thursday, October 16, 2008

Job Post and AMWA Announcement

First, the job post:

Now, this is something that just came out in AMWA's e-newsletter that you may be able to contribute to, if you like:

In conjunction with our Creative Readings session at the 2008 Annual Conference, we’re hoping to gather and publish “101 Ways to Know You’re a Medical Writer.” We’re inviting all members to contribute to this effort, whether they are attending the conference or not. If you plan to participate in our Creative Readings session, either by reading a creative work or by being in the audience, you can bring your ideas with you—Wednesday evening, October 22. Or, you can e-mail them to Donna Miceli (dmiceli@comcast.net) before the conference. We will share some of them during the creative readings session and, hopefully, publish them in some form afterwards. To get your creative juices flowing, here are some contributions that we’ve already received:

“You know you’re a medical writer when…

…your friends and family members start calling you for medical advice.”

…you sneeze into the crook of your elbow.”

…a medical abbreviations Web site is first on your favorites list.”

Wednesday, October 15, 2008

How to Write an Abstract

By Marco Bomfoco (Guest blogger)

An academic abstract is a short restatement of all essential points of a research paper. The abstract is one single paragraph and is subject to specific word limits, typically under 300 words. It stands alone bellow the title or at the end of the paper. Note that an abstract is NOT an introduction or a plan to the paper. In the words of Craig W. Allin, "abstracts are an exercise in writing with precision and efficiency."

In fact, the abstract is written after the investigation and the whole article is completed. It should be written in the same language as the paper and should be translated into one of the world languages. We can say that the primary purpose of an abstract is to permit a quick appraise of the applicability, importance and validity of a research paper. But always recall that the reader KNOW the subject but HAS NOT READ the paper.

The abstract presents the information in four general sections: INTRODUCTION, METHODS, RESULTS and CONCLUSIONS. It is worth noting that an abstract is only text and follows strictly the logical order of the paper. That is, the abstract ought to parallel the structure of the original paper. At the same time, it adds NO new information, i. e. that is not stated in the paper. Now notice that the abstract can be viewed as an independent document. It is because of this that it should be unified, coherent (i.e. providing appropriate transitions or logical linkage between the information included), concise, and able to stand alone. In other words, the abstract should be complete in itself.

Surely, it is sometimes the case that an abstract will be read along with the title and in general it will likely be read without the rest of the document. In fact, we might consider that the abstract is the most important part of a scientific paper. It follows, then, that it is an absolute must to include all the keywords related to the study. Notice that keywords (also called search terms) represent the most important terms or concepts (words or phrases) relevant to your topic.

There are two types of abstracts: descriptive and informative. The descriptive or indicative abstract, identifies the contents of the research or the basic subject of the article, demonstrating the paper’s organization without providing results or conclusions. Thus, it is not very informative. This type of abstract is always very short, usually under 100 words; and it is useful for a long report. On the other hand, the informative abstract, which is also known simply as a summary, gives the principal argument and summarizes the principal data, providing the reader with an overview of the objectives, methods, results and conclusions of the study. So, be specific. You may also have heard of a "structured abstract" -- this is a subtype of the informative abstract which has more than one paragraph.

What to include?

The content of the abstract includes:

  • Motivation and purpose: main subject or research question and review of the relevant literature.
  • Specifics: problem statement, approach, objectives, hypothesis, research methodology (method(s) adopted or search strategies).
  • Results: main findings (proposed solutions to the problem) and discussion.
  • Conclusions and implications/outcomes: what the results mean and further points

As we can see, the abstract must state:

  • The problem addressed and some background information.
  • The solution or insight proposed (newly observed facts).
  • An example that shows how it works.
  • An evaluation: a comparison with existing answers/techniques.

Then, an abstract should provide answers for the following questions:

  • What and why.
  • What you found.
  • How you did it.

But how do we begin?

What would be an effective way to begin an abstract? To help you on your way let us consider some introductory sentences.

First, let us see some opening sentences that DO NOT offer real information:

  1. This paper reports on a method for...

  2. The paper explores the notions of...

  3. The purpose of our research is to consider how...

  4. The objective of this study is to determine...

Thus, it is clear that you should avoid writing a statement of scope.

On the other hand, the sentences bellow represent good examples of introductory statements, for they go directly into the subject. They give something to the reader. Let us see how it works:

  1. The development process of hypermedia and web systems poses very specific problems that do not appear in other software applications, such as…

  2. Given a large set of data, a common data mining problem is to extract the frequent patterns occurring in this set.

  3. According to many recent studies the effect of learning style on academic performance has been found to be significant and mismatch between teaching and learning styles causes learning failure and frustration.

Do’s and don’ts of abstract writing

  • Do write a single paragraph.

  • Do meet the specific word length.

  • Do answer the questions: what, why, and how.

  • Do use familiar language to the reader.

  • Do use a few keywords.

  • Do write short sentences.

  • Do improve transitions between the sentences.

  • Do use active voice.

  • Do use third person singular.

  • Do begin with a clear introductory statement written in the present tense.

  • Do use past tense in the main body.

  • Do write a concluding statement in the present tense: just tells what the results mean (e.g. "These results suggest...").

  • Do fix grammar.

  • Do use headings, subheadings and tables as a guide for writing.

  • Do print and reread the abstract.

  • Don't cite the sections of the paper.

  • Don’t include references to the literature and to figures and tables.

  • Don’t use abbreviations.

  • Don’t add new information.

  • Don't add superfluous information.

  • Don’t add opinions.

  • Don’t repeat information.

  • Don’t repeat the article title.

Marco Antônio Bomfoco is a professor at the Faculty of Technology SENAC in South Brazil. A Ph.D. from Pontifical Catholic University of Rio Grande do Sul, and an M.A. from the same university, Marco is a long-time language enthusiast. His many interests include writing, general linguistics, anthropological linguistics, case theory and grammatical relations, history of linguistics, artificial languages, phenomenology, story telling, and myth. Article source here.

Medical Writing Jobs

Monday, October 13, 2008

How to Find Regulatory Writing Jobs

As I expected when I released the online course Introduction to Regulatory Writing in the US last month, interest is high for this type of course. As the government tightens its regulations on the pharmaceutical and biotechnology industries, the need for medical writers in the regulatory environment is growing.

So, if you want to find a regulatory writing job, you must first get prepared. You must know how the drug approval process works and how to prepare regulatory documents. You may learn about this at an AMWA workshop, enrolling at one of USP programs, or at MedicalWritingTraining.com.

Then, you need to create a strong resume and a relevant portfolio for your job hunting. I regularly post medical writing job openings in this blog, but there is a Web site I just visited that posts regulatory writing jobs. The visual presentation is very nice and they have a long list of openings. Check it out here. Even if you're not ready yet to apply for one of those jobs, read through the job descriptions and see what skills and experience are required. That will give you an idea of what to work on so you can get the best job possible.

Thanks for reading!

Thursday, October 9, 2008

About the AMWA Conference

The 2008 AMWA Conference is just two weeks away. Because of all the issues with the hurricane in the past few weeks, my attendance was at risk but it seems that I'll be able to go to Louisville after all.

However, because I could only decide to attend until this week, the organizers canceled my roundtable on self-publishing and gave the klatch on blogging to another leader. But I'll still be presenting an open session on Friday morning titled, "Communicating Health Risks." The session will review the role of medical writers as risk communicators, discussing how to best mediate between the scientific assessment of risk and the public's perception of risk.

Please come by and say hello if you get a chance. Thanks for reading!

Monday, October 6, 2008

Graduate and Certificate Programs in Biomedical Writing

Tomorrow, Tuesday, October 7 USPS will host a live chat session to answer questions about the programs they offer:

  • Master of Science in Biomedical Writing
  • Certificate in Regulatory Writing
  • Certificate in Medical Marketing Writing
Click here to register.

Sunday, October 5, 2008

Getting Back to Normal (and Jobs)

After a few hectic weeks on the road thanks to the hurricane, things are getting back to (a different) normal. Galveston is not the same. Anyway, just to get started again, here are some job postings.

Saturday, September 13, 2008

Posts and Hurricane Ike

It may be a while before I resume posting regularly to the blog again. I left my home in Galveston, TX a couple of days ago, fleeing from Hurricane Ike and am not sure when will I be able to return.

Thanks for reading!

Wednesday, September 10, 2008

The Drug Regulatory Process in the United States

Medical writers working in the regulatory environment must know well the process a candidate drug goes through before approval by the FDA. Below is a quick overview of the drug development process.

1. Preclinical Testing

Laboratory tests and animal studies are conducted. These studies show biological activity of the compound in relation to animal models of the targeted human disease or condition. Along with these results, the compound is evaluated for toxicology.

2. Investigational New Drug Application (IND)

An Investigational New Drug Application (IND) is filed with the U.S. Food and Drug Administration (FDA) after completion of preclinical testing. This allows testing of the drug in humans to begin.

3. Phase I Clinical Trials

Small numbers of healthy volunteers are tested with the drug to determine its duration in the bloodstream and the drug’s initial safety profile. This study also provides information about how the drug is absorbed, distributed, metabolized, and excreted in humans.

4. Phase II Clinical Trials

Approximately 100-500 volunteer patients with the disease or condition are tested with the drug to assess its effectiveness.

5. Phase III Clinical Trials

A large number of patients (usually at least 1,000-5,000 subjects) in clinics and hospitals are tested and monitored closely by physicians to confirm efficacy and to identify any adverse effects.

6. New Drug Application (NDA)

If the drug is determined to be safe and effective, an New Drug Application (NDA)
is filed with the FDA at completion of the clinical trials.

7. Drug Approval

Once the FDA approves the NDA, physicians may prescribe the drug to patients.

8. Phase IV

If patients report adverse effects after taking the drug, the FDA may require Phase IV trials to evaluate long-term effects of the product.

The Regulatory Writing Online Course describes this process in depth.

Monday, September 8, 2008

Attracting New Writing Clients

By Cheryline Lawson (Guest blogger)

Every business needs new clients and writers are no different. If you want to start out as a freelance writer and are confident with your skills, the next step is to showcase your craft by finding writing assignments that match your skills.

There are millions of Internet business owners that need fresh content press releases, articles, blog posts, and forum posts. There are more businesses online than there are writers. It is really very easy to find clients online.

However, in the beginning, you may have to accept smaller jobs and when you build your portfolio, other clients will notice you. You can start your own blog and post content on your blog frequently. You can use those blog posts as samples, so make sure the posts are between 400 to 500 words long.

Your blog will act as a working resume so that the online business world can take notice of you and your skills. You can use your blog for additional income by placing affiliate links that include books and products about writing or working from home.

Be sure to have a sample writing resume. Place the resume on your blog, but exclude your address and phone number. Be sure to include your email address as contact for your prospects or clients. You should write your best articles and post it to your blog. Write on different topics to show your versatility.

You can also search for freelance writing opportunities online. You can hang out at different forums and make wise and informative comments so that Internet Marketers can get a sneak preview of your expertise. Make sure you include your blog website in your forum signature file.

You can attract new clients by bidding on writing projects at elance.com and getafreelancer.com. However, you do need a good writing portfolio and writing samples for your client to view. In most instances, the client will request a sample or two.

Be careful of clients who want to underpay you for your skills. It happens. You will be offered as low as $2 per 500-word article. Even if you are starting out, this is really low. If you are confident and know that you are good writer, do not settle for low pay per article. It is a waste of your time. I know this might seem very harsh to a new client, but if a client wants good quality content, he or she will pay more than $2 because in the end, the client will get what they pay for.

Be professional at all times and treat your writing assignments as if it were your very own. Do a good job and the client will want to do repeat business with you. If you get a client who only needs a few articles, always follow up with the client so that you are not forgotten.

You will attract specific clients if you write in a certain niche market. Let's say that that you are a skilled medical writer, you would then find those clients that have medical writing projects or technical writing projects. You can pick your niche and stay in your niche or you can be a writer who is an excellent researcher who can write on any topic. You have more options when you write on any topic.

Cheryline Lawson is a passionate writer who uses her talent to alert the public about issues that need addressing. She is a hired writer who writes books, ebooks, ecourses, articles, blogs, forum posts and reviews. Find out more by visiting her website. Article source here.

Wednesday, September 3, 2008

Regulatory Writing Course Released

I'm excited to announce the release of the new online course at MedicalWritingTraining.com, "Introduction to Regulatory Writing in the United States."

Many people had asked for this type of course for a long time and it is finally here.

If you are a regular reader of this blog, you have heard (read) me say that regulatory writers are the best-paid professionals in the Medical Writing Industry. In fact, many of them earn six-figures. So, it is natural that you want to break into regulatory writing. This new course can help you do just that.

The good news is that I have created a special introductory offer for the first 30 people who sign up for the course. Click here to read more about this offer and the course.

Friday, August 29, 2008

Publishing a Consumer Health Book and Free Giveaway

Writing a book seems scary, but it is actually an exciting endeavor. A couple of months ago, I published my first consumer health book and the reviews have been great. In fact, another review is due to appear in the next issue of the AMWA Journal.

If you have written or are writing a book, you have two options: self-publishing or traditional publishing. Both options have advantages and disadvantages. If you will be attending the upcoming AMWA conference, and would like to learn about how to create your own publishing company, consider registering for my breakfast roundtable on Thursday, October 23.

But maybe you want to go with a traditional publisher. Then, you'll have to learn several things such as getting and agent, writing a book proposal, formatting your manuscript, etc. Last year, I interviewed multi-published author Ada P. Kahn about how to write a book proposal for a health-related book.

I will give away the audio of that interview to every person who orders Becoming a Medical Writer or any of the courses at MedicalWritingTraining.com during this holiday weekend (until Sept 2).

Thanks for reading!

Thursday, August 28, 2008

Sr. Medical Writer Position

Job Title: Sr Medical Writer

Location: Northridge , CA

Job Type: Permanent

Assume responsibility for an array of medical/technical documentation
activities associated with Clinical Research organization. The
qualified candidate will work directly with other medical/technical
writers and biostatistician to prepare, edit, and organize a variety
of technical documents that include presentations, manuscripts for
peer-reviewed publications, clinical evaluation report and study
protocols. Will also be responsible for educating members of the
Clinical Research staff in the area of effective visual and written
communication along with making sure that content contained in all
documentation conforms to company design control and legal
requirements. Will interface with Document Control, Research and
Development, Marketing, and Program Management where needed to ensure
the accuracy, timely review, and dissemination of all cross-
functional documentation.

Position Responsibilities

• Prepare, format, and submit summarizes data from clinical studies
for submission to the Food and Drug Administration (FDA).
• Coordinate, prepare, and submit abstracts for presentation at a
variety of annual diabetes meetings
• Review and edit protocol produced by members of the Clinical
Research staff.
• Collaborate with Document Control to development and implement
systems that ensure the timely release of technical documentation
• Work with internal and external resources to enhance the access of
relevant information to all Clinical Research staff. Efforts may lead
to the formation of a library type structure.
• Responsible for the following: Writing or substantively rewriting
investigator's brochures, final reports, papers for
scientific/medical journals, risk/benefit and integrated data
summaries, literature summaries, and position papers according to ICH
guidelnes.
• Working with project management to set timelines. Drives timelines
for projects.
• Ensuring high quality with regard to scientific content,
organization, clarity, accuracy, format, consistency, and adherence
to regulatory and internal guidelines.

Basic Qualifications

• Bachelor's Degree

• 3 years of medical writing work experience

• Candidates must be independent critical thinkers, deadline and
detail oriented, and able to manage multiple projects in a fast-paced
environment

• Proficiency in the use of technical publication tools

• Extensive knowledge of Microsoft Office and the ability to create
documents that seamlessly integrate spreadsheets, images, and text

• Verbal communication skills necessary communicate with an array of
technologists with widely varying backgrounds

• Ability to write technical summaries and articles for internal and
external publication

• Ability to present information to top management

• Ability to read, analyze, and interpret common scientific and
technical journals

Desired/Preferred Qualifications

BS in a scientific discipline

5 years of medical writing experience preferred

Previous experience within a Clinical Research or Regulatory
organization is preferred.

Understanding of diabetes and the medical device management of
diabetes

Be able to show examples of medical reports, papers, and documents
previously created
Contact:

Shanta Lama
Tel: 973-481-0100 Ext: 3069
Fax: 973-481-1020
shanta.lama@vernascientific.com
www.makrotech.com

Tuesday, August 26, 2008

Medical Writing Job Opening

Director/Associate Director, Medical Writing - Medimmune, Gaithersburg, MD


Major Duties and Responsibilities (including supervising others):
  • Under minimal or no supervision, writes and edits clinical study reports, protocols, informed consent forms, and other clinical and regulatory documents including Investigator Brochures and annual reports as needed.
  • Leads the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed.
  • Manages and develops direct reports, including performance reviews and regular 1:1 meetings.
  • Identifies and manages contract writers as needed.
  • Provides critical review of clinical regulatory documents from direct reports.
  • Provides resource projections for preparation of clinical regulatory documents within therapeutic area.
  • Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
  • Assists in or leads the preparation or revision of SOPs, WPDs, and document templates.
  • Participates in clinical project team meetings as needed.
  • Participates in or leads other cross-functional team meetings and standards committees.
  • Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.
Experience:
  • 6+ years experience writing clinical regulatory documents including clinical study reports.
  • Previous supervisory experience with direct reports or contract writers required.
  • Pharmaceutical industry experience required.
  • Background in biologics a plus.

Special Skills/Abilities:
  • Experience writing and editing clinical regulatory documents.
  • Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
  • Excellent writing, editing, attention to detail, and verbal communication skills.
  • Proficiency in Microsoft Word is essential.
  • Familiarity with CTD, ICH, GCP, and other standards.
  • Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.

Job Complexity: Medium to High

Supervision: Low to None

If you are interested in this position, apply online at www.medimmune.appone.com and search for Req 01038.

Free Webinar on Medical Publications

On August 27, 2008, Thomas Purcell and colleague, Stacey Shehin, are presenting on the topic of medical publications and the use of outside resources. The format is an interactive Webinar that is free to anyone interested in this topic. You can register here.

Monday, August 25, 2008

Regulatory Writing Basics

The Food and Drug Administration (FDA) regulates the pharmaceutical industry in the United States. The FDA has five centers, which are responsible for prescription and over-the-counter drugs, medical and radiological devices, food and cosmetics, biological products, and veterinary drugs.

The FDA’s Center for Drug Evaluation and Research (CDER) evaluates the safety and efficacy of new drugs before they go on the market. But CDER does not conduct testing of drugs—that is the responsibility of the pharmaceutical company which develops the product. The company tests the drug in animals and humans and then submits documents with evidence of its safety and effectiveness. Scientists at the FDA then review the documents submitted.

As a regulatory writer, possible documents you would write include clinical study reports, investigator brochures (manuals on conducting a clinical trial), and regulatory submissions (INDs, NDAs, CTDs, MAAs). Click here to read more about these documents.

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.

Are you interested in regulatory writing? In a couple of weeks I will release an affordable and comprehensive online course called "Introduction to Regulatory Writing in the United States." So stay tuned.

Saturday, August 23, 2008

Job Post and Upcoming Certificate in Regulatory Writing

Regulatory Affairs- Publishing Manager (Pharma) - Ft Worth, TX
Job Number: LAR4167

DESCRIPTION: Publishing Manager- Regulatory Affairs will be responsible for managing the day to day workload and activities of Associate and Specialist level publishers; identifying, proposing and implementing plans for the publishing department of a large pharmaceutical company. This position will prepare SOPs, publish complex submissions and interface with the IT and R&D departments to assure federal compliance in the publishing area.
REQUIREMENTS: 5-7 years of increasing responsibility in a Reg Affairs role, BS/BA, MS preferred, significant publishing experience with management and leadership ability.
COMPENSATION: High: $106,000.00 with Stock Incentives, 10% Bonus,
Generous Relocation and amazing benefits. Low: $100,000.00

Format your resume in MS Word or Corel WordPerfect and send it to: lar4167@jobquestsite.com as an attachment.


Regulatory Writing Certificate: As you can see from the post above, regulatory jobs are the best paid in the medical writing industry. Next month I will release a new online course on regulatory writing. I have teamed up with an expert regulatory writer to put this course together and offer a most-needed certificate in this area. So sign up for my blog updates and I will let you know when the course is released.

Wednesday, August 20, 2008

Forum on Plain English

The Forum on Plain English which will be held at the University of Houston-Downtown, on September 26, 2008. The forum aims to promote informed uses of Plain English guidelines, which are writing standards recommended by several government agencies for improved communications with the general public.

The forum will consist of three sessions led by Plain English scholars and experts that will cover the following topics:

1. History and current status of Plain English regulations

2. Plain English guidelines and application

3. Limitations/challenges/ethical implications of Plain English

Date: September 26, 2008 Location: A-300, Academic Building, UHD, One Main Street, Houston TX 77002.
Free lunch, free parking and free books. You must RSVP by September 1, 2008. More info here.

Monday, August 18, 2008

Freelance Medical Writing

By Brian Konradt (Guest blogger)

Technical writers are those who distill complex information, concepts and multi-step procedures into a form that is what we would now call "human-readable." Every manual, instruction booklet, professional FAQ and troubleshooting guide was produced by a technical writer who took raw instructions and made them understandable to even the most technique-ignorant layman.

A medical writer does a job very much along these lines, but instead of operator's instructions, medical writers produce simple summaries of medical procedures, scientific data, descriptions of medical equipment, and piece together reports on performed research (such as drug trials).

To be taken seriously, you're going to want some standard technical writing of a fairly high level nature under your belt. Make sure your skills are up to scratch, and then consider the following: unlike a lot of generalized technical writing, medical writing can require specialized training to help you encapsulate the basic meaning of professional medical documents. You may want to invest in a basic course or certificate that gives you what you need. Try putting together your own portfolio of comprehensive mocked-up writing samples to validate your expertise.

Medical writing centers more on writing skills and experience, rather than knowledge of specific medical paraphernalia. Always remember what it is being looked for. By the same token, however, the more clinical expertise you have, the better! Real world experience is always valuable. Enlisting in laboratory work as a volunteer in your spare time not only gives you that experience, but it also allows you to buddy up and network with lab employees who may have access to bigger and better companies in related fields.

Similarly, if you have access to a university library, view their medical section and see how professionals master medical writing. There are many examples of distilled data available online, as well, so work that Googling impulse into the ground to get a good idea of the range of material you may find yourself working on.

Freelance job marketplaces, like GetAFreelancer.com and Elance.com, can provide useful once-off jobs that get your name out there; however, to reap the rewards of steady clients and better pay, contact agencies, market yourself directly to companies, and hunt down jobs in the local newspaper or trade magazines. This is a relatively new field that is only now beginning to grow. While it's an exciting time to freelance as a medical writer, it's also one where your biggest priority should be establishing yourself in time for the boom, when the profession flourishes.

As a freelancer, your job will be that much harder, and often you'll find yourself wondering where all the work went. At times like this you'll want to have an ability to consult others in your field, which is where membership to such organizations as the American/European/Australian Medical Writers Association (A/E/AuMWA) comes in. Networking (are you sensing a pattern here?) and contacts within the industry are what you need to give you ties to the private companies (mostly pharmaceutical in nature) that outsource their medical writing.

As always, big paychecks will come from large corporate entities. Writing formal regulatory documents for federal bodies -- while a stuffy and time-consuming task filled with legalized mumbo-jumbo -- is worth plenty to drug companies which want their product to pass muster with the Powers That Be. If you're the one who can put together the report that does the trick, then the price-tag around your neck will drastically increase.

In the meantime, before the checks with all those zeroes on them (and plenty of numbers in front of them, as well) start rolling in, concentrate on exposure: blog your work for the world to see; and diversify into general issue science/technical writing as a way of putting your name out into the marketplace. Published items in diverse fields with your name on them says that you're a writer capable of adapting to whatever comes your way. Look into publishing or transcribing work for magazines and publications of any kind as a way of bolstering your public persona. Best of all, when you feel ready, make a concerted effort to get published within peer-reviewed medical/science journals, even as a co-author or collaborator, because your name next to New England Journal of Medicine (for example) tends to set off the right kind of alarm bells in a potential employer's head.

Public presence in a new and exciting field of employment is what will net you lucrative contracts and pay off all that hard work and pavement-pounding.

Brian Konradt is a freelance writer for www.FreelanceWriting.com, a free website offering freelance writing jobs and hundreds of writer's guidelines to paying magazines. Read his blog for freelance writers. Article source here.