Friday, June 26, 2009
Monday, June 22, 2009
New Course at Medical Writing Training
Today we are releasing the new online course "Clinical Trial Reporting and Regulatory Writing for Medical Writers."
This new course was developed by a regulatory writer with more than 20 years of experience in the field, and it will show you how to develop:
While the Introduction to Regulatory Writing course teaches the drug development and approval process in the US, the Clinical Reporting Course is a practical guide to prepare the regulatory documents involved in clinical research.
The course has been released at an introductory cost of $197, but will go up to $247 on July 6, 2009. Click here for more information.
This new course was developed by a regulatory writer with more than 20 years of experience in the field, and it will show you how to develop:
- Pre Investigational New Drug (IND) Application
- Investigational New Drug (IND) Application
- Investigational New Drug (IND) Reports
- Informed Consent Form
- Investigator’s Brochure
- Clinical Reports
- Pre New Drug Application (Pre-NDA)
- New Drug Application (NDA)
- Patient Narratives
- Manuscripts
While the Introduction to Regulatory Writing course teaches the drug development and approval process in the US, the Clinical Reporting Course is a practical guide to prepare the regulatory documents involved in clinical research.
The course has been released at an introductory cost of $197, but will go up to $247 on July 6, 2009. Click here for more information.
Friday, June 19, 2009
Wednesday, June 17, 2009
Dallas-area medical news writer needed
Medscape has an immediate need for an experienced Dallas-area medical news writer to write news stories at the following meeting.
American Society for Metabolic and Bariatric Surgery 26th Annual Meeting (ASMBS), 06/21/09- 06/26/09, Grapevine, TX
We would like to get 5 news articles from the meeting and can pay $300 per article.
Each article should be about 400-800 words. Each article should have interviews with at least two sources, (1) the presenter/lead investigator and (2) an independent commentator who can provide perspective on the study's findings. Preferred independent experts include (a) the session moderator and/or someone from the society board (president, vice president, etc), (b) someone recommended by the presenter as someone who can comment on the study, or (c) a random attendee of the session (last resort). Most important is that the independent commentator not be involved with the study (hence, the independent part).
Deadlines would be 2-3 articles due during the meeting, and the remainder within a few days after the end of the meeting.
Candidates must have experience in writing medical news and interviewing physicians. Style guidelines and sample articles will be provided.
Qualified candidates should send resume and clips via email to Deborah Flapan, director of Medscape Medical News, at dflapan@medscape.net. No phone calls, please.
American Society for Metabolic and Bariatric Surgery 26th Annual Meeting (ASMBS), 06/21/09- 06/26/09, Grapevine, TX
We would like to get 5 news articles from the meeting and can pay $300 per article.
Each article should be about 400-800 words. Each article should have interviews with at least two sources, (1) the presenter/lead investigator and (2) an independent commentator who can provide perspective on the study's findings. Preferred independent experts include (a) the session moderator and/or someone from the society board (president, vice president, etc), (b) someone recommended by the presenter as someone who can comment on the study, or (c) a random attendee of the session (last resort). Most important is that the independent commentator not be involved with the study (hence, the independent part).
Deadlines would be 2-3 articles due during the meeting, and the remainder within a few days after the end of the meeting.
Candidates must have experience in writing medical news and interviewing physicians. Style guidelines and sample articles will be provided.
Qualified candidates should send resume and clips via email to Deborah Flapan, director of Medscape Medical News, at dflapan@medscape.net. No phone calls, please.
SCIENCE Magazine Internship
(SCIENCE News department)
Science, the world's leading journal of original scientific research and global news, seeks a three-month intern to help implement and manage social media projects for its news department. The candidate should be very familiar with Facebook, Twitter, and other social networking platforms, and should have experience creating content for these platforms. Other duties will include promoting news content on the internet, moderating comments on our daily news site, and repurposing news content for multimedia projects. Some writing and research assistance for our online news site is possible. The ideal intern will have a science background-or at least a strong interest in science-and some journalism experience. The internship will be at our Washington, D.C. headquarters.
For consideration, send a resume and cover letter to AAAS, Human Resources Department, 1200 New York Ave., NW, Suite #101, Washington, DC 20005. (Attn: Requisition #1763) You may also reach us by Fax at 202-682-1630 and e-mail at jobs@aaas.org. Visit us at www.aaas.org. EOE. Non-smoking work environment.
Science, the world's leading journal of original scientific research and global news, seeks a three-month intern to help implement and manage social media projects for its news department. The candidate should be very familiar with Facebook, Twitter, and other social networking platforms, and should have experience creating content for these platforms. Other duties will include promoting news content on the internet, moderating comments on our daily news site, and repurposing news content for multimedia projects. Some writing and research assistance for our online news site is possible. The ideal intern will have a science background-or at least a strong interest in science-and some journalism experience. The internship will be at our Washington, D.C. headquarters.
For consideration, send a resume and cover letter to AAAS, Human Resources Department, 1200 New York Ave., NW, Suite #101, Washington, DC 20005. (Attn: Requisition #1763) You may also reach us by Fax at 202-682-1630 and e-mail at jobs@aaas.org. Visit us at www.aaas.org. EOE. Non-smoking work environment.
Wednesday, June 10, 2009
Next CME Course Begins July 1, 2009
For those of you not familiar with Johanna Lackner-Marx's course, "Become a Continuing Medical Education (CME) Specialist," she developed a series of online courses (basic, intermediate and advanced) designed specifically for medical writers interested in entering the CME industry.
The Advanced level includes one-on-one coaching and a two month Fellowship program for graduates. This Fellowship enables writers to get the experience they need to be competitive in the CME market, produce CME documents for their portfolio, add to their resume, and provides them with an opportunity to make important connections in the CME industry.
The first group of students began in January and now enrollment is open for the next group. The next advanced course will begin on July 1, 2009. Click here for more information.
Tuesday, June 9, 2009
Clinical Trials, CROs and Medical Writing
In the past, I have written about the drug regulatory process in the United States and why it is important that medical writers understand that process.
Medical writers are often responsible for creating the documentation required for a drug's clinical trials. They can work directly for the pharmaceutical company doing the trials or for a Contract Research Organization (CRO) that provides medical writing services.
An article on the DialedIn blog, describes this service model:
There are two types of service provider models used by emerging pharmaceutical companies to complete Phase I studies: the full service Phase I model and the ala carte model. Some Contract Research Organizations (CROs) provide full Phase I services which consist of the following:
- Study Site Services (IRB approval, drug packaging, medical monitoring, consenting, enrollment and randomization)
- Clinical Laboratory Services
- Drug Concentration Assay Services
- ECG Services
- Pharmacokinetic Modeling
- Biostatistics
- Clinical Data Management
- Clinical Study Monitoring
- Medical Writing
- Safety Reporting
Some CROs may also provide protocol development services. The advantages of the full service model are continuity of services and a single contract with a single provider.
Some emerging pharmaceutical companies make good use of the ala carte model for research services. In this model, a set of service providers is selected to provide the above Phase I services with each provider covering its niche area of expertise. For example, a particular CRO may be strong in biostatistics and clinical data management and would provide only those services on the trial. While the management of this type of model is more challenging for the sponsor company, it can provide a better end product.
CROs are great places for new regulatory writers because they can be exposed to the many facets of clinical trials (and because CROs may hire more junior medical writers than the pharmaceutical companies). So if you are seeking to break into regulatory writing, consider working for a CRO.
Saturday, June 6, 2009
Webinar for Freelance Writers
This is from an advertisement from Writer's Digest, on a topic that may interest some of you.
Money's a tough topic at the best of times – and in a down economy, it's infinitely harder to get your clients to talk frankly about budgets and fees.
But you can learn from freelancers who've been there and found useful ways to get the financial information they need. Join Marketing Mentor Ilise Benun for a discussion with 2 creative solopreneurs about the nitty gritty of talking to clients about money.
How to Talk to Clients About Money (especially in a tricky economy) is presented by Ilise Benun on June 17th at 7:00 pm ET.
Jeff Barlow of Seattle-based Jelvetica, and Julia Reich of New York-based Julia Reich Designs will show you how they handled potentially difficult conversations with both prospects and clients. You'll learn how they:
- Found out whether a prospect could afford them, before agreeing to do a proposal
- Got numbers from a prospect who insisted they didn't have a budget
- Responded to the dreaded "Your fee is too high"
- Listen in to find out how they did it and what, exactly, they said. They'll share their perspective on the process, from initial request to proposal to start of project (some they got, some they didn't) with both past clients and new clients.
In addition to the one-hour webinar, you'll also receive a download of the complete presentation.
Register here.
Friday, June 5, 2009
Writer Position at AAS
Writer II
AAAS (Office of Public Programs)
Successful candidate will take responsibility for all weekly press support
corresponding to Science Translational Medicine. Tasks will include: writing
about Science Translational Medicine research in weekly tipsheet briefs and
press releases; planning and executing media outreach strategies to raise
awareness of the journal and the discoveries it publishes; responding to
queries from journalists; ensuring that the Science embargo is upheld;
communicating with Editorial staff; recruiting artwork from Science
Translational Medicine authors; developing simple multimedia features such
as Skype video interviews and audio files; working with other Science press
package staff to plan press conferences or other events; performing other
work related duties as assigned.
Qualifications: Position requires extensive university or college level
training leading to a Bachelor's degree (Journalism and/or science
preferred); three to five years of relevant writing experience conveying
complex scientific material and concepts for a lay audience; and
demonstrated excellent, accurate science writing skills. Previous experience
in a newsroom or public information office is desired, as are excellent
verbal, written and interpersonal skills and proven organizational skills.
Computer skills, including Microsoft Office (Word, Excel, PowerPoint);
Dreamweaver and Final Cut Express, are also preferred.
For consideration, send a resume and a cover letter along with salary
requirements to AAAS, Human Resources Department, Job Requisition #1755;
1200 New York Ave., NW, Suite #102, Washington, DC 20005. You may also
reach us by Fax at 202-682-1630 and e-mail at jobs@aaas.org. Resumes
submitted without job requisition number and salary requirements will not be
considered. Visit us at www.aaas.org. EOE. Non-smoking work environment.
AAAS (Office of Public Programs)
Successful candidate will take responsibility for all weekly press support
corresponding to Science Translational Medicine. Tasks will include: writing
about Science Translational Medicine research in weekly tipsheet briefs and
press releases; planning and executing media outreach strategies to raise
awareness of the journal and the discoveries it publishes; responding to
queries from journalists; ensuring that the Science embargo is upheld;
communicating with Editorial staff; recruiting artwork from Science
Translational Medicine authors; developing simple multimedia features such
as Skype video interviews and audio files; working with other Science press
package staff to plan press conferences or other events; performing other
work related duties as assigned.
Qualifications: Position requires extensive university or college level
training leading to a Bachelor's degree (Journalism and/or science
preferred); three to five years of relevant writing experience conveying
complex scientific material and concepts for a lay audience; and
demonstrated excellent, accurate science writing skills. Previous experience
in a newsroom or public information office is desired, as are excellent
verbal, written and interpersonal skills and proven organizational skills.
Computer skills, including Microsoft Office (Word, Excel, PowerPoint);
Dreamweaver and Final Cut Express, are also preferred.
For consideration, send a resume and a cover letter along with salary
requirements to AAAS, Human Resources Department, Job Requisition #1755;
1200 New York Ave., NW, Suite #102, Washington, DC 20005. You may also
reach us by Fax at 202-682-1630 and e-mail at jobs@aaas.org. Resumes
submitted without job requisition number and salary requirements will not be
considered. Visit us at www.aaas.org. EOE. Non-smoking work environment.
Wednesday, June 3, 2009
Biomedical Writing Teaching Position
We are seeking highly qualified applicants for a 12-month, fully budgeted, non-tenure-track faculty position in the College of Veterinary Medicine and Biomedical Sciences, Texas A&M University. This position is to teach Biomedical Science (BIMS) 481 (Seminar in Writing).
Requirements: The successful candidate will hold a master’s degree in science journalism, biological sciences, education, or a related field. Candidates should have professional experience plus academic instruction experience and the ability to multi-task and work cooperatively with others.
Duties: The position will comprise approximately 40% preparing and administering PowerPoint lectures, 57% grading writing assignments, 2% interacting individually with students and 1% other duties as assigned.
Texas A&M University is located in College Station, Texas, USA. City facilities, cultural and athletic events, and other features of living in the community may be found by following the links here .
A city profile for College Station, Texas, may be found here .
Application process: Individuals interested in applying should send a letter of interest outlining their qualifications, a current curriculum vita, contact details, and the names and contacts for three professional references. Applications may be submitted either electronically (by e-mail and attachments) or by post. All materials should be sent to:
Ms. Dana J. Parks
Administrative Assistant to the Department Head
Department of Veterinary Integrative Biosciences
Texas A&M University
College Station, Texas, USA 77843-4458
(Voice) +1-979-845-3268
(Facsimile) +1-979-847-8981
dparks@cvm.tamu.edu
Requirements: The successful candidate will hold a master’s degree in science journalism, biological sciences, education, or a related field. Candidates should have professional experience plus academic instruction experience and the ability to multi-task and work cooperatively with others.
Duties: The position will comprise approximately 40% preparing and administering PowerPoint lectures, 57% grading writing assignments, 2% interacting individually with students and 1% other duties as assigned.
Texas A&M University is located in College Station, Texas, USA. City facilities, cultural and athletic events, and other features of living in the community may be found by following the links here .
A city profile for College Station, Texas, may be found here .
Application process: Individuals interested in applying should send a letter of interest outlining their qualifications, a current curriculum vita, contact details, and the names and contacts for three professional references. Applications may be submitted either electronically (by e-mail and attachments) or by post. All materials should be sent to:
Ms. Dana J. Parks
Administrative Assistant to the Department Head
Department of Veterinary Integrative Biosciences
Texas A&M University
College Station, Texas, USA 77843-4458
(Voice) +1-979-845-3268
(Facsimile) +1-979-847-8981
dparks@cvm.tamu.edu
Monday, June 1, 2009
Off-Label Promotion of Prescription Drugs - Should Medical Writers Be Concerned?
By Cyndy Kryder (Guest blogger)
In the prescription-drug industry, off-label use of prescription drugs is not that unusual. Health care providers are permitted to use a drug or device off label, that is, in an unapproved manner. Pharmaceutical companies, however, are not allowed to market or promote their products for any uses other than those approved by the US FDA.
In January, 2009, Eli Lilly and Company agreed to pay $1.415 billion to resolve allegations that it promoted its antipsychotic product, Zyprexa, for off-label conditions. This huge fine includes a criminal fine of $515 million and an additional $800 million in a civil settlement with the federal government and the states. Among health care cases, this is the largest fine on record, and the largest criminal fine for an individual corporation ever imposed in a criminal prosecution in the United States.
If you're a medical writer who writes content for pharmaceutical sales and marketing materials, should you be concerned? In my opinion, medical writers need to be aware of the regulations surrounding off-label use, and help clients by avoiding writing about off-label uses when that content will appear in promotional materials, since that is illegal. About the only places where writing about off-label uses may be acceptable is in continuing medical education (CME) programs, textbooks, and clinical study reports (CSRs).
When medical writers are hired by our clients, we are expected to create content that is accurate and well referenced. That means that writers need to be acutely aware of a product's approved uses. If you include information about off-label use in something you are writing, you need to state that this is an unapproved use. Once the content we create is out of our hands, however, we have no control over how that content is ultimately used. It is incumbent on the company marketing and promoting the product to ensure that all materials comply with government regulations.
Still, it's impossible to know what kinds of repercussions might follow a medical writer who creates content for materials that are later used illegally to promote prescription drugs. The ongoing investigation into the influence the pharmaceutical industry has on physicians has already resulted in the public naming of a reputable medical communications firm and the medical writers it hired. A year ago, most medical writers would have thought this impossible, but today I'm not so sure. The best strategy in the current environment is to write accurately, cite your sources, and keep copies of the final drafts as they left your computer, just in case.
You can read the Department of Justice press release about the case and its resolution here.
Cyndy Kryder, co-Author of The Accidental Medical Writer. The Accidental Medical Writer is for everyone who is frustrated with working for someone else. For everyone who wants the freedom and security that freelance medical writing can help them achieve. Visit our website at the link above for information, inspiration, strategies, lessons, and tips to help you become a successful freelance medical writer, too. Article source here.
In the prescription-drug industry, off-label use of prescription drugs is not that unusual. Health care providers are permitted to use a drug or device off label, that is, in an unapproved manner. Pharmaceutical companies, however, are not allowed to market or promote their products for any uses other than those approved by the US FDA.
In January, 2009, Eli Lilly and Company agreed to pay $1.415 billion to resolve allegations that it promoted its antipsychotic product, Zyprexa, for off-label conditions. This huge fine includes a criminal fine of $515 million and an additional $800 million in a civil settlement with the federal government and the states. Among health care cases, this is the largest fine on record, and the largest criminal fine for an individual corporation ever imposed in a criminal prosecution in the United States.
If you're a medical writer who writes content for pharmaceutical sales and marketing materials, should you be concerned? In my opinion, medical writers need to be aware of the regulations surrounding off-label use, and help clients by avoiding writing about off-label uses when that content will appear in promotional materials, since that is illegal. About the only places where writing about off-label uses may be acceptable is in continuing medical education (CME) programs, textbooks, and clinical study reports (CSRs).
When medical writers are hired by our clients, we are expected to create content that is accurate and well referenced. That means that writers need to be acutely aware of a product's approved uses. If you include information about off-label use in something you are writing, you need to state that this is an unapproved use. Once the content we create is out of our hands, however, we have no control over how that content is ultimately used. It is incumbent on the company marketing and promoting the product to ensure that all materials comply with government regulations.
Still, it's impossible to know what kinds of repercussions might follow a medical writer who creates content for materials that are later used illegally to promote prescription drugs. The ongoing investigation into the influence the pharmaceutical industry has on physicians has already resulted in the public naming of a reputable medical communications firm and the medical writers it hired. A year ago, most medical writers would have thought this impossible, but today I'm not so sure. The best strategy in the current environment is to write accurately, cite your sources, and keep copies of the final drafts as they left your computer, just in case.
You can read the Department of Justice press release about the case and its resolution here.
Cyndy Kryder, co-Author of The Accidental Medical Writer. The Accidental Medical Writer is for everyone who is frustrated with working for someone else. For everyone who wants the freedom and security that freelance medical writing can help them achieve. Visit our website at the link above for information, inspiration, strategies, lessons, and tips to help you become a successful freelance medical writer, too. Article source here.
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