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 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
• 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

• 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

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

Shanta Lama
Tel: 973-481-0100 Ext: 3069
Fax: 973-481-1020

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.
  • 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 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: 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 and, 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, 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.

Monday, August 11, 2008

Regulatory Writing Training

I'm still working on some training materials for those interested in regulatory writing. In the meantime, I came across this announcement of an audio conference titled, An Introduction to Regulatory Writing: Creating an Effective Message, that you might want to check out.

I have not listened to it and I don't know the speaker, so I can't provide any guarantees about the quality. If you do buy it, please let us know if it was any good.

Thanks for reading!

Wednesday, August 6, 2008

AMWA Annual Conference - Spots Filling Up Quickly

AMWA has posted a list of activities for the annual conference that have reached their capacity and are now closed (my discussion about blogging included!).

This is a reminder to register now, or else you won't be able to take that workshop or roundtable you want. I hope to see you in Louisville in October!