Medical Writer

Redesign and Three New Courses at MedicalWritingTraining.com

2010-11-02T10:34:00.001-05:00

We have completely redesigned our web site, www.MedicalWritingTraining.com and are launching three new courses:

1. Scientific and NIH Grant Writing and Editing

2. Writing and Organizing a Scientific Journal Article

3. Preparing Scientific Abstracts and Posters

WE HAVE MOVED

2010-10-29T12:21:00.002-05:00

Job postings and other articles are now being published at the MedicalWritingTraining.com web site.

In the meantime, the archives of articles will remain on this Blogger site. Please click on the link above to see the new medical writing jobs available.

AMWA 2010 Annual Conference

2010-10-07T12:05:00.002-05:00

November 11-13, 2010 - Milwaukee, WI

Tomorrow is the dealine to register for workshops for credits.

Regsiter here.

Medical Writing Positions

2010-09-20T10:30:00.001-05:00

Two new CME PDF's for medical writing

2010-08-20T00:00:00.000-05:00

I wrote to you a couple of days ago telling you about a new opportunity
to learn more about CME medical writing, and how to become a CME Medical
Writer if that's your interest.

My friend Johanna Lackner Marx has JUST posted her second PDF, so
now you can log in and learn how to research and write Needs Assessments
based on gaps in physician learning, but how to effective Educational
Objectives that meet CME requirements.

Did you know that medical errors are one of the top leading causes of
patient deaths, around the world? There is a new worldwide movement
taking place to identify gaps in clinician knowledge, train about those gaps,
and then follow up to see if patient care has improved. It's a whole new
exciting way of healing the world through physician learning and improvement
in care.

Check out Johanna's material here.

The materials are available for FREE until September 2.
If you like them enough, you can register and train with Johanna through her
online course, "CME Training for Medical Writers."

Johanna is a Nationally Certified CME Professional, and a true expert in both
CME and Training. She's got a wonderful module in her course on how
physicians learn. You'll see! Click here.

2011 - A New Career Direction for YOU?

2010-08-17T06:20:00.002-05:00

My friend Johanna Lackner Marx, MPH MSW CCMEP owns InQuill Medical Communications,
LLC, and they have a stellar training program I thought you should know about.

Have you ever thought of earning income in a new way, adding some new tools to your kit?

InQuill focuses on CME medical writing - that's researching and writing medical content that goes into continuing educational programs for physicians - otherwise known as CME Continuing Medical Education.

I think with your background that you might be a good candidate to learn CME Medical Writing, if you are interested in the possibility of a new source of income. The whole world of CME has changed radically in the last few years. There is a new set of requirements for CME, and physicians now have to take a lot more CME course hours to maintain their licensure. That means there is a shortage of
CME Medical Writers who know the new rules and can supply the growing demand
for CME Content.

InQuill is right at this sweet spot of opportunity. They specialize in CME Medical Writing, and Johanna is a nationally certified CME Professional - she's an expert at the top of her field. She knows CME, she knows how to train, she knows how to get CME work.

For the next two weeks until September 2, Johanna is pre-recruiting potential
students for her in-depth, on-line course, "CME Training for Medical Writers."
Courses start each month in September, October, and November.

To let you know more about InQuill and what they have to offer, Johanna
is offering a private FREE peek into portions of her CME course content.

If you visit the website link below, and submit your information, Johanna
will open up the world of CME for you with informative emails, PDF downloads,
and pieces of video training, all of which will have you learn about CME, and
evaluate if this is a potential path for you.

Click here to find out more.

If you want to enroll for the course, great. I make a small commission for bringing you this information. Then you get to become a CME expert and start your new career in CME Medical Writing.

If you choose to pass, please accept the FREE content from both Johanna and me. It cost you nothing except a bit of your time.

Medical Writing Available Positions in the US, UK, China, and India

2010-08-12T10:05:00.003-05:00

2010 AMWA Annual Conference registration is now open!

2010-07-26T10:49:00.001-05:00

From an AMWA email message:

Conference registration opened today for the 70th Annual Conference of the American Medical Writers Association (AMWA). There are new workshops, new certificates, and 40 open sessions (open sessions are included in your registration fee). Don’t forget that if you are not currently an AMWA member you can pay your dues along with conference registration and receive the member rate.

Register early for the annual conference workshops and roundtables! They fill quickly, so you’ll need to include 2 alternatives in case your first choice is not available when your registration form is processed. Online registration is not automatic on receipt by AMWA. All registrations are processed by AMWA headquarters in the order received, whether online, mailed, or faxed. Headquarters typically receives 400 registrations in the first day. Be prepared, be patient, and please give staff time to process. Thank you!

Available Breakfast Roundtables agendas have been linked in the registration brochure.

Hotel reservations are now open for the Hilton Milwaukee City Center, connected to the convention center via an enclosed skywalk. You can make your reservations online or you can contact the hotel directly at (414) 271-7250. Please make sure you identify yourself as an AMWA attendee to receive the discounted conference rate. Our group code is AMWA. The Hilton Milwaukee City Center is the official AMWA annual conference hotel.

Medical Writing Positions in the US

2010-07-20T14:58:00.003-05:00

Webinar to discuss the new AMWA curriculum

2010-07-01T13:42:00.001-05:00

WHEN: Thursday, July 8, 8:00 pm OR Saturday, July 10, 10:30 am

SIGN UP: Contact Jeanie Woodruff at jwoodruff@amwasouthwest.org at your earliest convenience to sign up for one of the sessions.

WHY: Registration for the AMWA national conference in November will open on July 26. A number of significant changes have been made to the structure of the curriculum and the certificate tracks. These changes affect you if you are pursuing, or thinking about pursuing, an AMWA certificate—whether you are new to the process or well along in taking your workshops. AMWA Southwest is offering a webinar to help you understand the curriculum changes so you can plan your workshop schedule for the national conference.

WHO: Steve Palmer, PhD, ELS, past president of AMWA Southwest and current national Administrator of Chapters and Membership, will lead the discussion and answer your questions.

HOW: We will use GoToMeeting to produce the webinar, which you can conveniently access from your own computer. Audio/voice access is FREE if you have a headset or microphone/speakers on your computer; if not, you can view the webinar on your computer and access the audio/voice feature via a long-distance number (NOT FREE), which will charge you at your standard long-distance rate. Registrants will receive an e-mail with instructions for accessing the webinar.

CONTACT: Two identical sessions are offered, and registration is required. "Seating" is limited, so please contact Jeanie Woodruff at jwoodruff@amwasouthwest.org at your earliest convenience to sign up for one of the sessions.

Medical Writing Jobs in the US, UK and SA

2010-06-08T10:55:00.002-05:00

Becoming a Medical Writer Indian Edition

2010-05-13T18:22:00.002-05:00

Because we know of the explosion of the medical writing industry in India and the interest of many people to break into this wonderful career, we have decided to reduce the price of Becoming a Medical Writer Indian Edition from US$25 to US$12 (that's about INR 500).

Click here for more information and to buy the ebook.

Medical Writing Jobs in India, UK and US

2010-04-26T12:44:00.002-05:00

Scientific Medical Writer Position

2010-04-05T14:05:00.002-05:00

This job is in in Southern California, but relocation assistance is offered.

Responsible for writing and editing key Global Safety and Epidemiology (GS&E) documents for global regulatory submissions, including Periodic Safety Update Reports (PSURs), Risk Management documents (RMPs and/or REMs), post-marketing sections of NDA/MAA/INDs, and post-approval regulatory commitments as needed. Will work primarily with Global Safety Scientists, Global Safety Officers, and Epidemiologists to coordinate, prepare, review and format GS&E documents and reports with well organized and effectively summarized safety information, with high quality and within predetermined timelines. The Professional will support consolidation of Team/Reviewer comments and questions and conduct data quality checks as needed.

This is a position involving multi-disciplinary interaction within the various functional groups of GS&E as well as outside contributing departments, including Regulatory Affairs, R&D Clinical Development, Medical Affairs, Marketing, and on occasion Senior Management, Therapeutic Area Leads, and the Chief Medical Officer.

The Professional is responsible for tracking progress of assignments and for assisting with multiple ongoing projects. Helps implement new/modified departmental processes (SOPs, WIs, templates and forms, etc), and must operate with minimal supervision. Serve on cross-functional committees and teams, as applicable. Excellent oral and written communication skills are required, with a strong knowledge of, and experience in interpreting and applying, global pharmacovigilance and risk management regulations and guidelines.

· Assist GS&E staff in authoring draft and final documents, applying scientific assessment to content, and completing according to predetermined timelines. Work with GS&E colleagues and contributing stakeholders to consolidate and address feedback/questions arising from Team Review of documents.

· Support Quality checks of safety data and information as applicable to ensure accuracy and high quality documents. Perform technical QC for published submissions as needed.

· Keep up-to-date knowledge of regulatory document requirements and assure documents meet Regulatory requirements as well as departmental standards for formatting, consistency, and adherence to company Styles. Apply a solid understanding of content and formatting requirements for PSURs, RMPs/REMs and post-marketing sections of regulatory filings (NDA, MAA, IND). Work with GS&E staff to produce/update Common Technical Documents (CTD) templates and other templates as needed.

· Attendance at team meetings or cross-functional committees

· Supports GS&E in maintaining tracking system for safety related documents/deliverables, and assists with document archival in electronic document management systems.

Qualifications

Education and Experience

· An advanced degree (or equivalent experience) in health care, or other suitable combination of education and 5+ years of specific experience.

· Experience preparing PSURs, RMPs/REMs, and other post marketing safety reports for regulatory agency submission

· Understanding of EU and US Pharmacovigilance, Risk Management, and post-marketing safety requirements

· Familiarity with medical terminology, and MedDRA

Essential Skills and Abilities

· Excellent planning, organization, and communication skills (written and oral).

· Ability to compose and review scientific documents for content, grammar and style, with high degree of attention to detail and in consideration of stakeholder feedback.

· Assertive individual with a proven ability to work effectively and flexibly with others and with a team-oriented effort.

· Ability to track progress and manage multiple projects.

· Good understanding of requirements for post-marketing modules of the eCTD.

· Thorough knowledge of word processing and spread sheet programs (MS Word and Excel), Adobe Acrobat. Experience with electronic document management systems. Competency with automated data collection systems

CONTACT:

John Peace
jpeace@clinprosnet.com
P: 215-750-7500 F: 215-750-1398 C: 215-630-6848
www.clinprosnet.com

Regulatory Writing Position

2010-04-05T10:48:00.001-05:00

Responsible for researching, writing, and editing materials for regulatory submission. As a member of the medical communications team, relies on instructions and pre-established guidelines to perform the functions of the job.

Essential Functions:

Primary responsibilities are as follows:

1. Works with data management and clinical operations groups to review and interpret clinical trial data
2. Compiles, writes, and edits regulatory materials (IND/NDA), with specific emphasis on clinical study reports, investigator brochures, and SAE narratives
3. Assists other writers in the compilation, writing, and editing of regulatory materials
4. Manages review and revision processes for multiple, concurrent projects
5. Ensures quality of content and format of publications in accord with applicable regulations, guidelines, and corporate SOPs

Skills Required:

1. Knowledge of FDA regulatory requirements, Good Publication Practice (GPP) and ICH guidelines, including strong familiarity with the eCTD
2. Strong medical and/or scientific writing skills
3. Ability to work well in a team environment, with the ability to work effectively independently
4. Efficient project management skills
5. Good work ethic

Education or Equivalent Experience:

• Bachelor’s degree in applied or life science or communications, with a 3-5 years of medical, regulatory, or clinical writing experience in the pharmaceutical or biotech industry, or equivalent training and work experience. An advanced degree is preferred. Ophthalmology experience a plus.

Remuneration based upon experience.

Contact:

If interested, please forward résumé and salary requirements to careers@oraclinical.com.

Medical Communications Position

2010-04-05T10:38:00.001-05:00

The role of the Medical Writer, within the Medical Communications Department, has three primary components consisting of (1) Research – taking sole ownership of subject matter through guidance from internal subject matter experts or individual researching; (2) Organizational Skills – maintain a structured, disciplined process and organization to produce consistently high quality, on-time work product; and (3) Communication – impart the value and progress of projects to other members of the Ora team, interact in a professional manner with multiple layers of educated individuals, know your audience and write accordingly.

PRIMARY RESPONSIBILITIES:
Ensure a top-tier quality-product required to satisfy both very demanding internal and external clients.

• Set Strategic Growth Direction –
o Work with Manager of Medical Communications to plan future individual growth.
o Recognize potential business building opportunities with current clients.

• Lead the Writing –
o Take ownership of project subject matter through expert seeking of resources.
o Define the objectives and key messages clearly and concisely to all parties involved, prior to commencing project work.
o Ensure that all materials submitted to journals/clients/regulatory agencies are accurate and complete according to guidelines/requirements
o Write like your life depends on it.
o Maintain and track review process to ensure on-time completion and identify timeline problems prior to missing deadline.
o Provide constructive feedback to authors, reviewers and subject matter experts to constantly improve the workflow and product quality – do not be a stenographer, be a writer!

• Build and Maintain Relationships
o Interact with journal editors to place articles that are both requested by editors and those that are not requested.
o Interact with internal and external clients to gain an understanding of business needs and marketing initiatives to enhance the messaging platform.

• Flexibility Across Mediums
o Own project subject matter across and produce work across the entire life cycle of information including:
 Peer Review Journals (New England Journal of Medicine style)
 Presentation Slides
 Product or Therapeutic Category Fact Sheets
 Trade Journal Articles (Review of Ophthalmology, Ocular Surgery News)
 Scientific Meeting Abstracts and Posters

REQUIRED SKILLS AND ATTRIBUTES:
At Ora, your values, abilities, and track record of success are more important than direct experience. That being said, an ideal candidate would have the following:

• Advanced Degree preferred, but not required.
• Strong competencies in the following areas: intellect (the ability to learn, understand, innovate, and apply analytical rigor), personal skills (integrity, candor, excellence, etc.), and interpersonal skills (oral and written communication, emotional intelligence, customer service, etc.)
• Prior experience writing in the non-regulatory pharmaceutical space (Medical Communications, Medical Education) in the Ophthalmology or Allergy therapeutic areas.
• Proven ability to multi-task and follow-through and work both independently or as part of a larger team.
• Proficiency with Microsoft Office and presentation software programs (PowerPoint, Keynote).
• Enjoy and love writing, do not use it as a stepping stone.

To apply, go to http://www.oraclinical.com/

Open Medical Writing Positions

2010-03-01T12:19:00.003-06:00

Many of these positions pay around $100k or more, but require experience and knowledge of regulatory writing.

PLx Pharma - Seeking Contract Medical Writer

2010-02-10T12:42:00.001-06:00

PLx Pharma, a Houston area pharmaceutical company, is looking for an experienced medical writer who can assist in the preparation of reports and submissions to the FDA, related to:

- Reports of non-clinical studies. For example…

o Formulation studies in which materials are characterized via HPLC, FTIR, HPTLC, or other analytical methods;
o Non-GMP stability studies;
o Rodent studies evaluating safety and efficacy of test articles.
- Regulatory submissions, particularly related to various Chemistry, Manufacturing, and Controls (CMC) items. For example,…
o Integrated discussion of GMP stability programs for products in development, including synthesis of data;
o Summary and discussion of manufacturing process development, from pilot scale to commercial scale (i.e., enumeration of changes over time and at various scales, with rationale);
o Authoring various sections of the Quality (CMC) module of the Common Technical Document/New Drug Application for one or more products.

Our preference would be to identify one or more persons who are local, are experienced in producing reports for pharmaceutical/biotech companies, and have some familiarity with the various analytical methods mentioned. Although the writer need not be local, at least some direct experience is required. Expertise in pharmaceutics would be a plus.

This writing opportunity would be on a contract, part-time basis, but could occupy from 25% to 75% of a writer’s time, based on the projects that are ultimately assigned, availability, and rate.

Those wishing to be considered for this opportunity should email Jason Moore at jason.moore (AT) plxpharma.com, attaching a work summary or resume/CV.

Three Medical Writing Positions

2010-02-04T16:30:00.003-06:00

Medical Writing Jobs Around the World

2010-02-01T10:09:00.003-06:00

Free CME Webinar

2010-01-22T20:52:00.003-06:00

Check out this free informational webinar: CME TRAINING FOR MEDICAL WRITERS

This is the live webinar that Johanna Lackner-Marx offered some time ago but now she has recorded the presentation for anyone to see it online. It's good stuff.

Contract Medical Writer in Dallas/Fort Worth

2010-01-07T12:32:00.000-06:00

This is a full time in-house Medical Writing contract (long term with option to go perm) with a large pharma in the Dallas/Ft Worth, TX area.

Responsibilities:
- Develop, review, and edit technical documents including clinical study protocols, investigator's brochures, study reports, risk assessments, presentations, and regulatory submissions in relation to the safety evaluation of ophthalmic devices
- Perform periodic relevant literature searches and evaluations

Minimum Requirements:
- Bachelor's degree in life sciences
- At least 2 years of medical writing experience in pharmaceutical or medical device industry

Competencies:
- Fluent in English
- Excellent interpersonal, oral, and writing skills
- Detail-oriented and self-motivated
- Fast learner and able to manage changing priorities
- Able to organize, analyze, and interpret data with minimal supervision
- Proficient in MicroSoft Word, Excel, and PowerPoint

Preferred Skills/Qualifications:
- Knowledge of ophthalmology (cataract and refractive surgeries)
- Knowledge of medical device clinical trials and safety reporting requirements

Contact:

Jill Vandergrift jvandergrift@preceptlife.com
Precept Life Sciences
Subsidiary of Cambridge Global Services
727.812.3383 office
800.436.2212 x264 toll free
703.439.2482 fax
www.preceptlife.com

AMWA Southwest 2010 John P. McGovern Award Banquet and Lecture

2010-01-04T10:56:00.000-06:00

AMWA Southwest 2010 John P. McGovern Award Banquet and Lecture
"For the Love of Words: A Medical Writer's Story on Stage"
Saturday, January 16, 2010, 6:30 pm
Holiday Inn Houston South Loop
Houston, Texas

Registration deadline:
January 8, 2010

Mark your calendars for AMWA Southwest's 2010 John P. McGovern Award Banquet and Lecture, to be held Saturday, January 16, 2010, at the Holiday Inn Houston South Loop.

Receiving the chapter's 2010 McGovern Award will be stage and screen actress Megan Cole, known nationally for her workshops on empathic physician/patient communication and for her numerous public presentations on the human face of medicine for health care and end-of-life care organizations

Ms. Cole, who originated the leading role in Margaret Edson's Pulitzer Prizewinning drama "Wit" in 1995, is Artist-in-Residence at the John P. McGovern, M.D. Center for Health, Humanities, and the Human Spirit at The University of Texas-Houston Health Science Center.

Ms. Cole's McGovern Award Lecture will be "For the Love of Words: A Medical Writer's Story on Stage," in which she will recount her research into the influential life and career of Mayo Clinic medical editor Maud Mellish Wilson and present excerpts from the resulting stage play.

"Maud Wilson's story is most importantly a story about her love and care for words simply and accurately conveyed," says Ms. Cole.

The banquet will begin with a reception at 6:30 p.m., with complimentary hors d'oeuvres, beer, and wine. Dinner will begin at 7:15 p.m. and the lecture at 8:00 p.m. The registration fee for the banquet is $33 for members and $38 for nonmembers. A dessert-and-coffee-only option ($9 for members and $11 for nonmembers) is available for those who cannot attend the dinner but would like to arrive at 8:00 p.m. for the lecture only.

To Register for This Event
RSVP by Friday, January 8, 2010, to Jenny Denton at jwithers@amwasouthwest.org. Payment is required for each e-mail registration received. You may mail your check (payable to AMWA Southwest) in advance to Jenny Denton at 525 Lowell St., Dallas, TX 75214, or pay by cash or check at the door.

When registering, please provide the following information:
â— Your name
â— Your e-mail address or daytime phone number
â— Your AMWA status (member or nonmember)
â— Your meal option (dinner or dessert/coffee only)
â— Your choice of dinner entrée (dinner option only):
â— Pasta primavera (vegetarian)
â— Chicken Acapulco
â— Norwegian salmon

The Holiday Inn Houston South Loop (713-790-1900) is located at 8111 Kirby Drive in Houston, Texas, just off IH-610, northwest of Reliant Park and the Astrodome. The hotel is two blocks west of the Reliant Park stop of the METRO light rail. Parking at the hotel is free.

For more information, contact Jenny Denton by phone at 214-827-3342 or e-mail at jwithers@amwasouthwest.org.

Medical Writing Jobs in India and the US

2009-12-28T11:49:00.003-06:00

Medical Writing Positions in the US

2009-12-19T12:02:00.002-06:00

Medical Writer needed for physician-directed newsletter

2009-12-03T16:04:00.001-06:00

Baylor University Medical Center is seeking a writer for its 8-page quarterly newsletter, CancerUpdate, which is sent to approximately 2,000 physicians regionally and nationwide. The writer will be given an outline for each issue, with major themes and sources for each article, and will need to produce a draft with about a three to four-week turnaround and revise it with one-week turnaround. The first issue is available for review. We propose a fixed-price contract of $4,000 per issue.

To be considered, the writer must have at least 4 years of writing experience, including experience with newsletters and/or experience writing for a physician audience. Experience in the oncology field is also preferred.

If you are interested in applying for this contract position, please send a letter of introduction with a resume and samples. The closing date is December 18, 2009, and a writer for the next issue will be chosen by January 8, 2010, with work on the winter issue to being the following week.

For questions, or to submit your application, please contact:

Rosanna Sandlin
Senior Marketing and Public Relations Consultant
Baylor University Medical Center at Dallas
2001 Bryan Street, Suite 750
Dallas, Texas 75201

(214) 820-3062
(214) 820-7499 Fax
BaylorHealth.com

Medical Writing Jobs in the UK

2009-12-01T10:27:00.002-06:00

Fellowships in Science Writing

2009-11-24T11:32:00.000-06:00

Metcalf Institute for Marine and Environmental Reporting Announces Training Fellowships for Journalists

Two Unique Opportunities for Journalists to Focus on Science Reporting

NARRAGANSETT, RI – November 18, 2009 –The Metcalf Institute for Marine and Environmental reporting is recruiting journalists for two science training opportunities: the Twelfth Annual Science Immersion Workshop for Journalists, June 6-11, 2010; and a Metcalf Institute Science Seminar for Journalists, March 31-April 1, 2010.

The 12th Annual Workshop offers fellowships for early to mid-career journalists to attend a weeklong science immersion program at the University of Rhode Island’s Graduate School of Oceanography, a leading marine science research campus. The 2010 program Coastal Impacts: Energy Sources and the Marine Environment, will explore the value of different energy sources in mitigating climate change and how these options affect surrounding environments. A fellowship provides tuition, room and board, some travel support, and one year of membership with the Society of Environmental Journalists. There is limited space for non-U.S. citizens. Applications for the Twelfth Annual Science Immersion Workshop for Journalists must be postmarked by January 18, 2010.

Metcalf Institute and the Brown University Superfund Research Program will offer a two-day seminar for mid-career journalists at Brown University, entitled “Waiter There’s a Phthalate in My Soup” – Reporting on the Science and Impacts of Toxic Chemicals. This seminar, funded by a grant from the National Institute of Environmental Health Sciences, will feature leading environmental scientists and journalists, visits to research labs, and discussions on the communication of bisphenol-A and air quality impacts. The Science Seminar for Journalists is tuition-free and includes lodging, but travel costs are not included and space is limited. Applications for the Science Seminar for Journalists must be postmarked by February 8, 2010.

Reporting on the environment, public policy, and even business, often requires journalists to explain complex scientific research and its implications. Metcalf Institute fellowships provide opportunities for journalists to better understand environmental research methods, cultivate scientific sources and sharpen their reporting skills through fieldwork and labs. Fellowship recipients also benefit from informal, off-deadline conversations abut environmental reporting with researchers and veteran journalists. Both programs are available to journalists from all media who are interested in learning about science and the environment. Applicants should have a minimum of one to two years experience as professional journalists and a strong interest in science reporting.

Applications for both programs may be downloaded at www.metcalfinstitute.org. For additional program information, call 401-874-6211 or email fellowships@metcalfinstitute.org.

The mission of the Metcalf Institute for Marine and Environmental Reporting is to promote clear and accurate reporting of scientific news and environmental issues; to strengthen understanding and working relationships between members of the scientific community and members of the news media; and to provide opportunities for beginning journalists to learn, on both a formal and an informal level, how to improve their skills in marine and environmental reporting.

The Metcalf Institute for Marine and Environmental Reporting was established in 1997 with funding from three media foundations, the Belo Corporation, the Providence Journal Charitable Foundation and the Philip L. Graham Fund, and from the Telaka Foundation. It is named for the late Michael P. Metcalf, a visionary in journalism and publisher of The Providence Journal Bulletin from 1979-1987. The Metcalf Institute provides science training for reporters and editors to help improve the accuracy and clarity of marine and environmental reporting and offers journalism fellowships in support of diversity and reporting on science and the environment. For more information, contact the Metcalf Institute for Marine and Environmental Reporting at 401-874-6211 or online at www.metcalfinstitute.org.

More on Ghostwriting

2009-11-18T12:40:00.003-06:00

Check out this NYT article on ghostwriting and medical writing.

Cheers!

Medical Writing Jobs - Freelance and Full Time

2009-11-02T11:43:00.003-06:00

Jobs and Cool Risk Communication Graphic

2009-10-24T10:23:00.002-05:00

Now, a colleague sent me a link to a chart illustrating the risks of the HPV vaccine. Very telling. See it here.

Did you miss the CME Webinar?

2009-10-17T20:40:00.002-05:00

We had a great response from attendants to the Free Webinar "CME Opportunities for Medical Writers." But many said they couldn't attend because of schedule conflicts. That's why we are offering the seminar again on Sunday, October 25th at 11:00 AM EST.

Don't miss this opportunity to learn how to expand your medical writing business. Register for the FREE Webinar at the link below:

https://www1.gotomeeting.com/register/127287417

Medical Writing Position in NJ

2009-10-17T20:24:00.001-05:00

Sr. Manager, Medical Writing Job Description:

"Growing Pharmaceutical Company located in Princeton, NJ is seeking for a Sr. Manager, Medical Writing to join their organization"

Duties and Responsibilities:

-Serve as the medical writing (MW) representative on Project Teams.
-Provide input to the development of strategy for multinational clinical activities associated with registration and market support of a product.
-Review medical documents generated outside of MW (e.g. Study Protocols, Statistical Analysis Plans, Tables and Listings).
-Prepare/coordinate clinical documents as required (e.g. Clinical Trial Reports (Phase I – IV) and associated appendices, Investigator’s Brochures, Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, clinical sections of IND/IMPD/NDA/MAA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO as necessary.
-Prepare/coordinate clinical sections of submission (IND/IMPD/NDA/MAA//CTD) and responses to regulatory authorities, and implement medical writing activities. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians, data managers and drug safety group) as applicable. Discuss the objectives, timelines, and documents to be generated; coordinate contributions from other groups and pull together the documents in a efficient, non-disruptive manner for submissions to regulatory authorities.
-Manage the activities of internal/external resources and medical writing vendors (i.e. individual consultant medical writers and contract research organization (CRO) medical writers).
-Prepare/review SOP’s and document templates.
-Manage projects within pre-defined budget, pre-defined internal resources and time constraints
-Providing status reports for ongoing projects

Core Competencies:

-Demonstrated medical writing skills and high level interpersonal skills to interact effectively within team and matrix work settings. Sensitivity to cultural differences.
-Excellent written/oral communication skills and highly proficient word processing skills.
-Working knowledge of worldwide registration document requirements including ICH guidelines, EMEA requirements and FDA guidelines and requirements.
-Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.
-Ability to think clearly, get appropriate input from different disciplines as needed, provide focused answers.
-Team player who is cost conscious, adaptable to change, excellent organization skills, quality focused, with proven analytical and problem solving abilities.

Education and/or Experience Required:

-B.S. degree, advanced degree/Life Sciences preferred.
-7-10 years experience in regulatory writing or equivalent within the pharmaceutical industry, including managing 2-3 global registration dossiers
-Experience with contrast medical and imaging modalities preferred.
-Experience with an electronic based document management system.
-Vendor/consultant management experience preferred

Other:
-International travel, generally to European countries required, approx. 15%.

Required Skills:
MEDICAL WRITING, PHARMACEUTICAL MEDICAL WRITING

Join Aerotek Scientific LLC^SM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.

Contact Information


Contact:	Joanne Kang
Address:	371 Hoes Lane, Suite 203 Piscataway, NJ 08854
Phone:	(732) 447-1194
Fax:	(732) 447-1660

Free Webinar Tonight

2009-10-15T14:16:00.001-05:00

CME Opportunities for Medical Writers

Join us for a Webinar on October 15

Space is limited.
Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/354941312

• Continuing Medical Education (CME) medical writing can be very lucrative because it is specialized.
• There is a shortage of medical writers trained in CME, especially in the new rules.
• The playing field is as level as it will ever be for new writers coming into the world of CME.
• You can learn how to create valuable CME content for physician education.
• Now is the time to learn CME Training for Medical Writers and broaden your skill set for the future.

This FREE Webinar will show you how to take advantage of these new opportunities.

Title:		CME Opportunities for Medical Writers

Date:		Thursday, October 15, 2009

Time:		8:00 PM - 9:00 PM EDT

After registering you will receive a confirmation email containing information about joining the Webinar.

System Requirements
PC-based attendees
Required: Windows® 2000, XP Home, XP Pro, 2003 Server, Vista

Macintosh®-based attendees
Required: Mac OS® X 10.4 (Tiger®) or newer

Medical Writing Publications Manager Position

2009-10-12T11:10:00.001-05:00

Title: Medical Writing Publications Manager
Location: MD Gaithersburg - Corporate Headquarters
Req: 01879

Position Summary:

Major Duties and Responsibilities (including supervising others):
• Ensures the timely presentation/dissemination of clinical data from investigational pipeline products according to budget timelines strategic publication plans and tactical approaches.
• Ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts abstracts posters oral presentations etc.) are accurate and supported by appropriate data.
• Oversees the entire publication development process working closely with authors thought leaders medical writers and other cross-functional publication team members.
• Ensures the quality and transparency of clinical publications by maintaining and promoting familiarity with ICMJE CONSORT AMA and other external standards as well as MedImmune’s publication policy and procedures.
• Creates and maintains publication records in the e-publication system and related files in the document management system ensuring that all author feedback and publication versions are archived.
• Leads cross-functional publication development team meetings and communications among team members.
• Participates in the development of strategic publication plans and tactics attends publication planning team meetings.
• Manages contract resources in the development of publications to meet objectives in a cost efficient and timely manner effectively using project management skills.
• Develops and actively manages relationships with journals sponsor congress organizations and publishers; prepares cover letters and response to journal letters and submits publications for review.
• Creates publication timelines and provides regular publication project status reports to Director Publication Writing and to publication planning teams.
• Develops and improves industry best practice in publication management; participates in the preparation or revision of SOPs and WPDs.
• Oversees the maintenance of database of bibliographic references across assigned therapeutic areas.

Experience:
• 5+ years writing/editing publication experience in pharmaceutical industry communications agency or academic setting relevant to clinical publication development.
• Lead author of 8+ clinical/scientific publications or formal medical writing acknowledgment in 8+ clinical publications.
• Previous experience with management of publication-related vendors required; supervisory experience for direct reports a plus
• Strong track record (5+ years) in publication management required.

Special Skills/Abilities:
• Previous experience writing and editing peer-reviewed clinical publications (manuscripts abstracts posters oral presentations review articles etc.) required.
• Demonstrated ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Demonstrated leadership qualities to gain credibility and influence cross-functional publication teams and external authors and thought leaders; high degree of influencing skills in shaping and developing publication content and wording.
• Demonstrated ability to make effective decisions even in the absence of complete information and when under pressure.
• Demonstrated ability to drive performance—holds others accountable for high standards and clarifies what needs to be accomplished and the consequences for the individual and/or the organization.
• Demonstrated ability to work collaboratively—seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/proposals.
Educations:
Requirements/Qualifications:
Education:
• MS degree in a biomedical discipline required; doctorate level (PharmD MD or PhD) preferred.
• AMWA BELS and/or ISMPP certification a plus.

CLICK HERE TO APPLY

Medical Writing Position in Los Angeles

2009-10-01T11:48:00.002-05:00

Scientific Communications Executive

Position Profile

Scientific Communications Executives work with public relations account teams to provide tactical counsel to clients and implement a variety of projects related to the communication of scientific or medical information. They also provide counsel to other healthcare offices within the agency network and assume responsibility for relevant projects and initiatives led by other teams.

Primary Responsibilities

Account/Overall
- Interpret and translate complex clinical or scientific data for lay and science press
- Develop proposals, fact sheets, handbooks, animated tutorials (scripts), web sites/copy, press releases and other materials
- Communicate credibly with professional (e.g., scientific) audiences
- Ensure scientific accuracy of documents other team members prepare
- Instruct staff in the areas of science writing and editing as necessary
- Contribute to the development of strategic client plans (e.g., data communication strategies and tactics)

Client
- Demonstrate a solid understanding of clients’ business and industry (typically pharmaceutical, biotechnology, medical device or other life science industries)
- Provide client counsel on tactical matters, linked to strategic plans and communication of scientific or clinical data
- Interact with clinical/scientific leaders on the client side
- Prepare and deliver tutorials on relevant scientific subjects
- Generate new ideas and opportunities to ensure client program success
- Assist with development of client presentations

Media
- Understand industry issues that directly and indirectly affect the client
- Demonstrate a well-developed knowledge of relevant media (e.g., science magazines, major healthcare reporters)
- Draft media relations materials (see above)

Qualifications

Education
Ph.D. in life sciences (biology, biochemistry, molecular biology, physiology, genetics, biophysics, etc.).

Professional Experience/Requirements
Proficiency with Word, PowerPoint, Excel
Excellent writing and speaking/presentation skills
1-2 years of related professional experience (PR agency or pharmaceutical/biotechnology company preferred); or
1-2 years continuing medical education/medical advertising experience; or
1-2 years experience as a journalist

Contact:
Frank Orrico, PhD
Senior Vice President, Director of Scientific Communications
P 312.397.6632
forrico (at) webershandwick.com

FREE Webinar: CME Opportunities for Medical Writers

2009-09-29T15:44:00.002-05:00

As a medical writer, you may be feeling the pinch of the economic downturn – fewer clients, fewer writing opportunities, and lower compensation. But wisdom always says that downturns are a great time to prepare yourself for the next wave, and to broaden your skills so that you can ride more comfortably in any economic climate.

There’s been a temporary downturn in the Continuing Medical Education (CME) industry as well. Medical device and pharmaceutical companies, long-time financial supporters of CME education, have reduced funding because of claims of excess influence and bias over CME content. Congress, the media, and the public are scrutinizing the CME industry, demanding bias-free content that improves physician competency and patient outcomes.

The upturn is coming. How? Knowledgeable medical writers are changing the ways in which CME is designed, created, implemented, and evaluated. New funding sources are being developed, and CME is now being more stringently required in medical recertification and licensing of physicians, particularly in specialties – all to improve patient care.

These changes create a HUGE OPPORTUNITY FOR WRITERS who want to break into lucrative CME medical writing, because everyone in the industry has to learn how to create CME that meets these new criteria.

Here’s the opportunity:

• CME medical writing can be very lucrative because it is specialized.
• There is a shortage of medical writers trained in CME, especially in the new rules.
• The playing field is as level as it will ever be for new writers coming into the world of CME.
• YOU can learn how to create valuable CME content for physician education.
• NOW is the time to learn CME Training for Medical Writers and broaden your skill set for the future.

If you want to learn more about this great opportunity, you must attend this FREE Webinar on October 15th, 2009. The webinar will cover:

1. The changes and updated criteria for CME, as outlined by ACCME (the Accreditation Council for Continuing Medical Education) and why YOU need to know them
2. What CME Providers are looking for in sourcing CME writers
3. Overviews of critical CME content areas
a. How to prove there is a need for physician learning
b. Creating educational goals and objectives that meet your identified needs
c. Creating CME content that is valid, current, and unbiased (from commercial interests)
d. Techniques that increase learning and improved physician performance in the clinical setting
e. How to construct post-learning evaluation tools that measure the effectiveness of your content
4. A brief presentation on how YOU can enroll in “CME Training for Medical Writers”, participate in a CME Internship Program, and how this can lead to your first paid CME job.

You get all this, PLUS, for attending this webinar, THREE FREE BONUSES to get you started in CME:

The 7 steps of a needs assessment – proving that physician education is needed
The 18 most frequently used sources to research the need for CME
A one-of-a-kind Chart that connects adult learning styles with the different formats of CME, so that your CME can be learned by physicians most effectively

REGISTER TODAY

The details of your FREE Webinar:

Who: Hosted by Diego Pineda of www.medicalwritingtraining.com, and
Presented by Johanna Lackner Marx, MSW, MPH of www.inquill.com

What: FREE Webinar: “CME Opportunities for Medical Writers”

When: Thursday, October 15, 2009, 5:00pm PST, 7:00pm CST, 8:00pm EST

Where: Click to Register for your FREE Webinar here

Medical Tribune – Medical Writer Job in Singapore

2009-09-29T11:26:00.000-05:00

Medical Tribune (www.medicaltribune.com) is a medical newspaper distributed to general practitioners, specialists and medical professionals throughout the Asia Pacific region. They are currently recruiting medical writers to work as journalists for their publication. This would be a full-time positions based in Singapore.

Qualifications / Skills

Degree in Journalism, Mass Communications or a medical/science field
Possess at least two years’ working experience, preferably at a publication or in an editorial capacity
Excellent news sense
Excellent writing, interviewing, proofreading, editing skills
Able to deliver high quality work under pressure of multiple editorial project deadlines
Time management and deadline-oriented: multi-tasking skills essential
Proactive and able to work independently

Responsibilities

Writing medical news reports for a professional audience
Interviewing key opinion leaders in the healthcare field
Work with managing editor to develop news angles for articles and develop contacts in medical industry
Proofreading and editing medical news and scientific reports
Coverage of local and overseas medical congresses, meetings and press conferences
Liaison with the pharmaceutical industry
Work with managing editor on development of pagination plan
Liaison with in-house design and production team on development of design, layout of copy and print production
Background research in topic area as required
Developing advertorial materials as required
Editorial support for partner journals, as required

Contact:

Paul Pimentel

Deputy Managing Editor

Medical Tribune

Medical Progress

Journal of Paediatrics, Obstetrics and Gynaecology

Email: paul.pimentel@asia.cmpmedica.com

Phone: +65 6223 3788

Fax: +65 6221 4788

www.medicaltribune.com

www.medicalprogress.com

CMPMedica Asia Pte Ltd

No. 3 Lim Teck Kim Road #10-01

Singapore Technologies Building

Singapore 088934

Two Medical Writing Jobs in the UK

2009-09-21T17:02:00.001-05:00

More About Ghostwriting in Medical Journals

2009-09-18T11:14:00.002-05:00

The controversy around marketing manuscripts disguised as scientific papers has created quite a reaction in the medical writing community. I'm glad to see that journal editors are taking steps to stop this practice.

This is what is happening, as told in this NYT article:

"... in light of recently released evidence that some drug makers have gone to great lengths to turn scientific articles into marketing vehicles for their products, some influential medical editors are cracking down on industry-financed ghostwriting. And they are getting help from some members of Congress.

"These editors are demanding that journals impose tougher disclosure policies for academic authors and that the journals enforce their own rules by actively investigating the provenance of manuscripts and by punishing authors who play down extensive contributions by ghostwriters."

These policies include retraction of the papers, and that “authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct reported to their institutions.”

That's all good and clear and hopefully they will actually implement these policies. But what about the medical writers that willingly ghostwrite articles at the request of pharmaceutical companies--sometimes slanting data? Should they be "punished" also? If so, how can we do that? And who would do it? AMWA? Congress?

Should ghostwriting be regulated in medical writing? What do you think?

Medical Writing Jobs

2009-09-09T00:23:00.002-05:00

Online Education & Medical Writing

2009-08-27T13:37:00.003-05:00

From a NYT article:

A recent 93-page report on online education, conducted by SRI International for the Department of Education, has a starchy academic title, but a most intriguing conclusion: “On average, students in online learning conditions performed better than those receiving face-to-face instruction.”

I've always thought that online education has many benefits (accessibility and affordability), but wasn't sure about its effectiveness when compared to on-site training. This is reassuring, because we are trying to take medical writing education online.

What is your experience with online education? Do you think you learn more than in a classroom setting?

CME Position for a Medical Writer in Dallas TX

2009-08-20T23:39:00.002-05:00

The Medical Writer provides content for continuing medical education (CME) activities including, print, online and live meetings as well as non-CME publications such as peer-reviewed journals and direct-to-patient magazines. This is a unique opportunity to apply your years of science training to an alternative career. You will interface with key thought leaders in the oncology community and your work will make a direct impact in the dissemination of cutting-edge information.

Functions include:

Research and evaluate current medical and scientific literature.
Develop content to meet internal customer requirements and requests including but not limited to:

-Needs assessments for grant proposals;
-Educational objectives and agendas for CME meetings;
-Articles for newsletters and journals;
-Slide kits;
-CME documentation.

Work collaboratively with thought leaders, program chairs, consulting faculty and supporters as necessary for content development.
Attend company and other relevant scientific meetings.
Review articles and slide sets submitted by faculty for scientific accuracy.
Meet established production timelines regularly and consistently.
Provide data necessary for departmental reporting activities including regular status reports as established by Director.
Assist in training new Medical Writers as requested.

You are well qualified for this opportunity if you hold a Ph.D. in a scientific discipline and, ideally, have 2 years of medical or scientific writing experience.

If you are interested in pursuing this opportunity, please email to recruiting@klanderson.com all of the following:

1. Resume in Word or Txt format
2. Salary requirement or history
3. Work authorization (H1B, green card holder, citizen, etc)
4. Relocation considerations, if applicable.

Medical Writing and Ghostwriting

2009-08-19T09:14:00.002-05:00

I think this was going to happen sooner or later: the US Senate is moving to stop scientific ghostwriting.

In the past decade (probably more), pharmaceutical companies have been hiring writers to prepare positive journal articles about their products and then pay researchers to lay their names as authors. This ghostwriting practice has been abused to the extent that these papers try to minimize the risks of drugs that have been otherwise shown as high-risk in independent research.

What strikes me about this issue (and the info in this NYT article) is the involvement of a medical writing company:

The documents offer a look at the inner workings of DesignWrite, a medical writing company hired by Wyeth to prepare an estimated 60 articles favorable to its hormone drugs. In one publication plan, for example, DesignWrite wrote that the goal of the Wyeth articles was to de-emphasize the risk of breast cancer associated with hormone drugs, promote the drugs as beneficial and blunt competing drugs. The articles were published in medical journals between 1998 and 2005 — continuing even though a big federal study was suspended in 2002 after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer and heart disease.

Sometimes medical writers walk a thin line when working for the pharmaceutical industry, but this is a blatant sell-out that gives a bad name to our profession. It used to be that the ghostwriter's goal was to organize the researcher's notes and data into a cohesive and clear article. I don't see anything wrong with that. But to publish marketing material as research is simply unethical. Click here to read an old post about AMWA's position on ghostwriting.

I hope universities take a stand against this issue and enforce their regulations on pharma-sponsored faculty.

2009-08-04T11:54:00.023-05:00

Become a CME Specialist

I've asked Johanna Lackner Marx to share some ideas about how medical writers can increase their marketability during this slow economy. As many of you know, Johanna is the Founder and President of InQuill Medical Communications, LLC. She has been a trainer and consultant in the CME industry for 15 years. She has created a comprehensive course on specifically geared toward medical writers interested in entering the CME industry, CME Training for Medical Writers.

In a series entitled "Succeed in a Down Economy - Put CME to Your Toolbox", Johanna will write about how medical writers can benefit from the recent changes in CME.

2009-08-04T11:09:00.022-05:00

SUCCEED IN A DOWN ECONOMY -
PUT CME IN YOUR TOOL BOX
Part 1: Using the Slump to Get Over the Hump

Guest Blog by Johanna Lackner Marx, MPH, MSW
InQuill Medical Communications, LLC
CME Training for Medical Writers

There is no doubt that the recession is affecting a lot of freelance medical writers. A friend of mine, who writes consumer health and patient education articles, recently told me that her business has decreased forty percent. Like a lot of us, she chose the freelance/entrepreneurial route over steady employment in order to be her own boss and have more control over her time and the type of work she does. Now, she says, she’s lucky to get enough new work to cover her basic expenses. She spends her day combing the Internet, sending out her CV, reaching out to contacts, and making cold-calls to strangers. Sound familiar? Last week during a well-deserved rant of frustration, she told me, “Until things turn around, I might as well use this time to learn statistics so I can finally tell the difference between a risk ratio and an odds ration instead of faking it.”

Using the slow down in the market to learn another skill is a good idea and a lot of writers are doing it. This year AMWA is offering over 100 educational sessions during the 3-day annual conference in October so members can “…gain new areas of expertise that can enhance their skills in the many facets of medical communication.” In addition to AMWA’s workshops, Diego lists eleven medical writing programs in his e-book Becoming a Medical Writer. He recently shared with me that his website, medicalwritingtraining.com has gotten a record number of hits in the past six months. The interest and demand is there.

When students fill out their enrollment form for CME Training for Medical Writers, they are asked to state why they decided to take my course. I’ve been surprised by the uniformity of responses. A few students have been successful regulatory or clinical trials writers, but want to work in a field where there is a more immediate sense of mission. Others are just starting out as medical writers and have decided they want to learn how to do CME. But the majority of students, like my friend, are accomplished medical writers who have taken a financial hit and want to add to their skill set so they can be more marketable.

In my next blog, I will tell you about some of the recent changes in the CME industry and how these changes have created a great opportunity for medical writers who know the regulations, the CME development process, and how to create effective content that physicians learn, retain, and use in the clinical setting.

Medical Writing Jobs

2009-07-27T18:50:00.002-05:00

AMWA Annual Conference Registration Now Open

2009-07-21T13:51:00.001-05:00

I just received this notice from AMWA:

AMWA Annual Conference October 22-24, 2009

The registration brochure has been posted and registration is now open!

Remember, workshops fill quickly, and you’ll need 2 alternatives in case your first choice is not available when your registration form is processed. All registration forms are processed by AMWA headquarters in the order received, whether online, mailed, or faxed. Headquarters typically receives 400 registrations in the first day. Be prepared and give staff time to process!

Available breakfast roundtables agendas have been linked in the registration brochure.

Become a CME Specialist

2009-07-20T19:03:00.003-05:00

This past week I heard good news from Johanna Lackner-Marx about her CME course for medical writers.

Some of her graduates are now placed at MECCs and CME departments completing two-month fellowships. The fellowships are a success and she anticipates that they will be hired by their placements to complete work they started during the fellowship.

This is a unique training program that not only gives you the tools to become a Continuing Medical Education specialist (that is, develop CME courses for physicians), but gives you the chance of participating in a fellowship conducting to a job.

The course was launched late 2008 but Johanna has reworked the content with the feedback and needs of her first graduates. Click here to see the new outline. If you want more information or to enroll in the course, go to MedicalWritingTraining.com/CME.

The Importance of Networking When Job Hunting

2009-07-15T12:47:00.002-05:00

Reading a NYT article over the weekend, I was reminded of the importance of networking when looking for a job or simply more freelance work. One phrase from the article stuck with me: "I tapped into a network of colleagues and friends and told everyone I was job hunting."

It occurred to me that sometimes we can be too proud or even ashamed to tell people we are looking for work, but that we shouldn't be--otherwise we'll miss some good job leads. This is specially true in freelance medical writing, where clients ask their networks for referrals to hire new medical writers.

A few months ago, I began transitioning from a full time job to telecommuting, then to part time and now into freelancing. I started looking for gigs in the usual places (Internet job postings, etc.) but nothing came out of it.

Then, a former colleague emailed asking how things were going and I mentioned that work was slow and that if she knew of something to please let me know. A few days later, she came back to me with a great freelance project from her organization which I was happy to take on. I hadn't even began working on this when a recruiter call me about another job. It turned out my colleague had mentioned my name to someone else in her company and they in turn mentioned my name to this recruiter.

So, don't limit yourself to sending out resumes to every company in the phone book. Network and let your colleagues and friends about your medical writing skills. Even in the midst of a recession, medical writers can still find jobs.

If you have had similar experiences about the importance of networking, please share them.

Thanks for reading!

Medical Writing Positions Around the World

2009-07-13T11:14:00.003-05:00

AMWA Annual Conference Registration

2009-07-07T07:21:00.002-05:00

Registration will open at 11 AM Eastern Time on July 20 for the 2009 Annual Conference in Dallas, TX, October 22–24. Check out the registration brochure here.

Back Online & Medical Writing Jobs

2009-07-04T12:23:00.000-05:00

I was out of town all this past week and didn't have a chance to post to the blog.

There are only two days left to enroll in the Clinical Trial Reporting course at the introductory price.

Here are some new job postings:

Medical Writing Jobs

2009-06-26T12:32:00.002-05:00

New Course at Medical Writing Training

2009-06-22T18:57:00.002-05:00

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:

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

This is a great complement to our existing course "Introduction to Regulatory Writing in the United States."

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.

Medical Writing Jobs in London

2009-06-19T08:16:00.002-05:00

Dallas-area medical news writer needed

2009-06-17T14:47:00.000-05:00

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.

SCIENCE Magazine Internship

2009-06-17T10:42:00.000-05:00

(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.

Next CME Course Begins July 1, 2009

2009-06-10T12:56:00.002-05:00

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.

Clinical Trials, CROs and Medical Writing

2009-06-09T10:35:00.004-05:00

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.

Webinar for Freelance Writers

2009-06-06T15:37:00.002-05:00

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.

Writer Position at AAS

2009-06-05T15:50:00.000-05:00

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.

Biomedical Writing Teaching Position

2009-06-03T06:01:00.000-05:00

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

Off-Label Promotion of Prescription Drugs - Should Medical Writers Be Concerned?

2009-06-01T20:32:00.002-05:00

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.

Three Medical Writing Jobs

2009-06-01T20:26:00.002-05:00

Clinical Trials Reports

2009-05-25T14:46:00.002-05:00

I thought I was going to have this ready by now, but with my move out of Texas and all the work with a book we are working on, the Clinical Trials Reports course had to wait.

We seem to be back on track with this and, if all goes well, we'll be releasing this course at MedicalWritingTraining.com next month. Just to give you a preview, these are some of the topics included in the online course:

Pre-submission Quality Control
Pre-IND, Pre-IDE
IND, IDE
Investigator Brochure
NDA, PMA
Panel Pack
Post-approval Reports
Recurring Regulatory Reports
Manuscripts & Abstracts

If you are not familiar with regulatory writing, you may want to look first at Introduction to Regulatory Writing in the US. The upcoming course is a great follow-up to that one, and it will show you how to write all these important reports.

Two Medical Writing Positions Available in the UK

2009-05-25T14:01:00.001-05:00

More to Medical Writing Than Meets the Eye

2009-05-22T13:37:00.002-05:00

By Cyndy Kryder (Guest blogger)

Think you only need to understand science to become a medical writer? Think again. Despite the term medical in the phrase medical writing, when you work in this field you won't be writing exclusively for medical professionals.

Depending on your niche and expertise, in addition to doctors, nurses, and other health care professionals, you might be writing for a lay audience (that's the common person), hospital purchasers, manufacturers and users of medical devices, pharmaceutical sales representatives, people in the insurance industry, or individuals who create and enforce public policy. That's a very broad range, and each of those groups will bring with them a different set of terms. To do your job well, you'll need to have a basic understanding of the language that's unique to each segment. Why? Because the more you know, the more marketable you'll be. And in today's economy, that's important.

So not only will you need to understand medical terminology, you'll also need a working knowledge of terms related to:

Health care
Insurance
Business and marketing
Education

You see, medical writing is not really one distinct genre, but one with a very broad scope and multiple components. In my opinion, medical writing falls into 3 categories: regulatory, promotional, and educational.

Regulatory writing, a very scientific type of writing, involves translating complex information from clinical trials into technical reports, some of which will be submitted to the federal government. Included here are study protocols, Investigator's Brochures (which are distributed to the scientists who head up clinical trials), patient narratives, and, in some instances, manuscripts detailing the outcomes of clinical trials that will be submitted to medical journals.

Promotional medical writing includes any materials created to promote, or sell, a prescription drug, intervention, or medical device. These could be any of the multitudes of sales-training materials (in print and other media) that are used to teach sales representatives about how a new drug or device works and to train them to sell it to prescribers. Target audiences for promotional materials are broad, and include the folks who sell the product, those who prescribe it, those who have influence on people who might prescribe it, and those who ultimately will cover the cost, either all or just a portion (third-party payers).

Into the educational category I lump anything a writer creates for continuing medical education (CME) programs, including writing needs assessments, as well as the content for the actual CME programs. I also consider patient education materials to be educational writing, since one of their purposes is to educate the consumer and family. I recognize that the ultimate goal of these materials may well be promotional, that is, to educate consumers to the point where they will ask their doctors to prescribe the product for them; however, I consider them educational, since they differ in style and tone from promotional pieces.

So you can see the target audiences for whom you could be writing can be quite diverse. And that's why you need to be knowledgeable about more than just medical terms.

Before you panic, throw your hands up in despair, and decide that medical writing is not for you, take a deep breath and calm down. You can do this. How do I know? Because I did.

Even though I had a bit of a science background when I entered the field, I still surrounded myself with great resources, like the ones that follow. If you're serious about becoming a medical writer, add some of these resources to your medical writing toolbox. You'll find them indispensible.

AMA Manual of Style: A Guide for Authors and Editors. This guide for authors and editors belongs on every medical writer's bookshelf.

Dorland's Illustrated Medical Dictionary, 31st edition. A must-have resource, this dictionary provides definitions for almost any medical term you'll come across.

Managed Care Digest Series®; Developed by the pharmaceutical giant, sanofi-aventis, this annual series of free hard-copy or electronic digests includes the Hospitals/Systems Digest, the Senior Care Digest, the eManaged Care Trends Digest, the Government Digest, and the HMO-PPO Digest. The individual digests contain information about all the major components of health care delivery and provide updated information and statistics incorporating data from Verispan.

mediLexicon; A searchable, online medical dictionary, mediLexicon provides definitions for terms, phrases, acronyms, and abbreviations. Powered by Stedman's Medical Dictionary and geared toward professionals, this site defines more than 100,000 medical terms.

Cyndy Kryder is an experienced freelance medical writer with more than 16 years of experience. As one-half of the Accidental Medical Writer writing team, Cyndy writes books for aspiring and experienced medical writers. You can find more medical writing tips at her website. Article source here.

SENIOR SCIENTIFIC MEDICAL EDITOR/WRITER

2009-05-19T12:15:00.000-05:00

The Texas Heart Institute in Houston, Texas, is seeking a senior scientific medical editor/writer for the section of Scientific Publications. The editor/writer in this position will be responsible for editing and writing all types of scientific publications and for managing publications projects. Applicants must have excellent written, editorial, and project management skills. Candidates should have at least a bachelor's degree in English, journalism, or science (with proficiency in English); a graduate degree is preferred. Applicants should also have 5 years' experience or commensurate academic or research experience. Advanced degree qualifies for experience. Completion of AMWA's certificate programs and BELS certification preferred. Candidates will be required to complete a short grammar and writing test and to provide writing samples.

Qualified applicants should send a résumé to Marianne Mallia, ELS, Texas Heart Institute, PO Box 20345, Houston, TX 77225-0345; FAX: 832.355.3714; e-mail: mmallia@heart.thi.tmc.edu .

Medical Writing Job

2009-05-16T20:26:00.000-05:00

Medical Writer, Contract, SWITZERLAND

AMA Manual of Style Online

2009-05-11T15:34:00.001-05:00

AMWA members get a discount on the AMA Manual of Style: A Guide for Authors and Editors by subscribing through amwa.org.

Medical News Writer Position

2009-05-11T15:31:00.000-05:00

Medscape Medical News has an immediate need for a medical news writer to cover the American Association of Clinical Endocrinologists 18th Annual Meeting and Clinical Congress (AACE), 5/13 - 5/17, in Houston.

The oral abstract and poster sessions start on Thursday, May 14. We would like to get 5 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).

The writer would need to register him- or herself as press directly with the society. A letter of assignment can be provided by Medscape if needed.

Once coverage is arranged, I can send style guidelines and sample articles. Please send resume and clips at first contact to dflapan@medscape.net .

Social Media and Medical Writing

2009-05-07T06:46:00.000-05:00

I thought that because I have a few blogs and a fairly active Facebook account, I had a pretty good grasp of social media. But I've discovered there is a lot to learn from some recent readings.

Anyway, we have been exploring how to reach other audiences through social media, especially when you take into account that in February 2009, social network usage exceeded Web-based e-mail usage for the first time (click here for the Nielsen report, The Global Online Media Landscape). For instance, our approach on the NNii web site has been the traditional text article with scientific references. But should we be adding videos, tag clouds, Twitter and Facebook pages? Should we hire a teenager to do all this?

One great example of integrating social media into health communications is the Web site of the Centers for Disease Control and Prevention, www.cdc.gov. They offer podcasts, mobile alerts, videos, widgets, facebook group, and more.

If you want to learn more about using social media, there are a lot of books, blogs and twitter feeds out there. I'm reading an ebook called The Zen of Social Media Marketing, which seems pretty good so far.

Thanks for reading!

Freelance & Full-Time Medical Writing Jobs

2009-05-07T01:37:00.002-05:00

Medical Writer Position in Houston

2009-05-04T15:25:00.000-05:00

Experienced professional writers with bioscience background needed at the John M. Eisenberg Clinical Decisions and Communications Science Center at Baylor College of Medicine in Houston. Work as part of a dynamic team of professionals translating medical research reviews into information products for clinicians. MA or MS required, PhD preferred. Must be an excellent writer with bioscience knowledge and comfortable with medical research reports and methods. Send cover letter, resume, writing samples and three references to Tom Workman at taworkma@bcm.tmc.edu. Baylor College of Medicine is an equal opportunity employer.

Swine Influenza and Risk Communication

2009-04-28T09:26:00.002-05:00

Real panic calls from family members: What do you think of the swine flu cases? Is this the end of the world? My response: Not the end of the world yet and no need for such an alarm. Let's just wait and see.

The new swine flu outbreak has not only brought more work to my table (we are preparing an article about it for the NNii Web site), but has me interested in the way these cases are reported. A few years ago, with the bird flu scare, many mistakes were made in terms of risk communication, which created panic in some, and apathy in others. The response to this new issue, of course, is varied. Not all the media react alike. But a recent article in the NYT, summarizes well our task as medical writers, informing without alarming:

The W.H.O. and public-health agencies like the Centers for Disease Control and Prevention find themselves in a delicate balance, obliged to provide information about potentially lethal diseases without causing panic.

Although health officials have held exercises to prepare for pandemics and outbreaks caused by bioterrorism, they have yet to master the necessary communications skills. They are in a “damned if they do, damned if they don’t” situation.

Check out my AMWA presentation on risk communication for some principles that you may apply if confronted with this situation. Also, read What to Say When a Pandemic Looks Imminent by risk communication experts Peter M. Sandman and Jody Lanard.

If you want to keep up with the swine flu outbreak, don't go to our local newspaper. Instead, look at a good source such as this one.

Medical Devices and the FDA

2009-04-22T09:34:00.002-05:00

It is not unusual to see pharmaceutical companies under investigation for dubious practices--like obscuring data from clinical trials or outrageous marketing tactics. But in recent years, the US Food and Drug Administration has also been under the gun.

Now, the issue is about the approval of certain medical devices. From an article in the NYT:

Nine dissident scientists signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers.

The FDA will have a chance to defend itself, but these kind of news affect the public's perception of the agency and in turn, it affects medical writers, who are in the midst of the controversy.

I wonder what circumstances surrounded the development of the regulatory documents submitted for the approval of these medical devices. Were the medical writers responsible for these documents aware of the reviewers' objections or not?

Maybe the objections were clear in the documentation submitted but the FDA approved the devices anyway (we don't know the details).

We'll see what comes out of this after the meeting and will know more details if the Institute of Medicine gets involved as the NYT article suggests.

Communications/Public Affairs Officer for Infectious Diseases Society

2009-04-14T12:29:00.000-05:00

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, the public, policymakers and other advocacy groups. The person will serve as a primary point of contact for reporters, and will write press releases and coordinate interviews with physician spokespersons. In addition, the person will write and/or edit two monthly electronic newsletters for IDSA and the HIV Medicine Association of IDSA. The person will also be responsible for writing letters to the editor, op/eds, and similar materials.

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

We offer an 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
Vice President of Communications
Infectious Diseases Society of America
1300 Wilson Blvd., Suite 300
Arlington, VA 22209
dolson@idsociety.org
Visit us online at www.idsociety.org and www.hivma.org.

Regulatory Writing Training for Non-Native English Speakers

2009-04-13T10:53:00.002-05:00

This may interest some of you who have come to the US from abroad and want to pursue medical writing, especially if you are already in biomedical research.

The course is titled "Writing in the Regulated Environment When English Is Your Second Language" and is offered by CfPIE.

Medical Writing Job in the UK

2009-04-10T16:51:00.001-05:00

Medical Writer UK based 30-40K

Forum Discussions at Medical Writing Network

2009-04-06T09:00:00.002-05:00

From time to time I like to call attention on interesting discussions at the MWN. You may be interested in participating in this one: Writing in Big Pharma - what would you like to know?

Two-Day Regulatory Writing Course (INDs)

2009-04-01T14:16:00.003-05:00

Barnett Educational Services is offering a two-day course called "Preparing IND Submissions: How to Organize, Write, Submit and Track Submissions" on June 10-11, 2009 in Philadelphia, PA. Registration is $1,595 by May 1 and $1,795 after May 1 (travel and lodging not included).

Is that too expensive? Consider taking the Regulatory Writing course at MedicalWritingTraining.com.

Medical Writing Job and Recommendation

2009-03-26T12:21:00.002-05:00

First, the job opportunity:

Medical Writing, Medical Communications, Pharmaceutical, London, Putne

Now, this recommended post by Orac in his Respectful Insolence blog.

Enjoy!

Telecommuting as a Medical Writer

2009-03-23T13:41:00.002-05:00

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

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

Telecommuting rocks. Oh yes, I love working from home, but it requires certain conditions to be successful:

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

The most important thing, however, is to enjoy your work. If you are miserable doing what you're doing, even if it is from home, you'll be better off going to an office and doing the type of medical writing you are passionate about.

Thanks for reading and happy telecommuting!

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

Medical Writing Jobs

2009-03-16T18:26:00.002-05:00

These openings are advertised through the Medical Wrting Yahoo group:

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

contract@cambridgeg roup.com

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

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

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

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

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

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

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

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

* *

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

-Two different Blue Cross Health Plans
-Dental Insurance
-401k
-Life Insurance & AD&D
-Long-term Disability
-Paid Holidays
-Up to 4 weeks of Vacation
-Continuing Education Reimbursement up to $5,250 /yr
-Section 529 Tax-Deferred College Savings Plan

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

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

2009-03-11T15:10:00.003-05:00

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

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

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

Free Course at MedicalWritingTraining.com

2009-03-09T11:48:00.001-05:00

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

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

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

Protecting Your Writing as Valuable Intellectual Property

2009-03-06T06:24:00.001-06:00

By Janet Switzer (Guest blogger)

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

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

A few hours spent protecting these assets is critical.

TRADEMARKS

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

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

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

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

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

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

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

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

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

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

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

A good intellectual property attorney can tell you more.

COPYRIGHTS

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

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

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

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

© 2009 Your Name

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

RELEASES FROM GUEST EXPERTS AND INTERVIEWEES

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

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

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

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

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

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

Conflicts of Interest at Harvard

2009-03-03T15:05:00.002-06:00

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

Can Anyone Be a Regulatory Writer?

2009-03-02T10:27:00.002-06:00

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

First, you must consider your background. Most regulatory writing positions at pharmaceutical and biotechnology companies require that you have an advanced degree (MD or PhD); some prefer or require experience in a particular therapeutic area. There are exceptions of course, and some CROs may give junior writers opportunities at regulatory writing.

“Our experience is that you need to be a good scientist first, preferably with a degree in the health sciences (pharmacist, pharmacologist, nurse) and then hopefully have a talent for writing,” says Larry Liberti, an experienced regulatory writer at Thomson Scientific. “The latter can be developed but it is rare to be able to train someone in the health sciences on the job.”

Second, you must be detail-oriented and be comfortable working with set guidelines and forms. If you are the creative type who likes to inject some art into your writing, well, you may want to try something else.

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

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

Thanks for reading!

Earning Money as an “Expert Who Speaks”

2009-02-25T08:56:00.002-06:00

By Janet Switzer (Guest blogger)

How would you like to travel to the world's most exciting places, help others with business advice and personal development, earn thousands per day selling your services, and hear the applause of a crowd sitting on the edge of their seats?

If your answer is "Yes!" you should consider adding professional speaking to your medical writing business.

How to Market Yourself as an International Expert Who Speaks

On any given day, thousands of conferences, workshops, meetings and other training events take place -- most of which need experts to deliver information the group can use. There are a number of different types of individuals and groups which hire speakers:

• Independent Meeting Planners are hired by companies to organize events including conventions, trade shows, workshops and conferences. They are also responsible for hiring the speakers for those events. Corporate meeting planners, on the other hand, are employees of a company who've been given the job of putting together the annual sales meeting, executive retreat or other event.

• Trade associations also hire speakers. They hold annual conferences and training events and want to bring good, solid information to their members in order to provide value for the association dues members pay every year. Trade associations look not only for high-profile motivational speakers, but also for experts who speak on their subject matter.

• Non-profit organizations, educator's organizations and charities also conduct a lot of training, hold conferences and have a need for speakers.

• One of the biggest buyers of speaker's services are network marketing and direct sales organizations -- not only the parent companies, but also individual "leaders" with large downlines of distributors or direct sellers.

• Other trainers, training companies and seminar promoters can also be customers for your speaking and training services, especially if you can deliver expertise they’re not able to provide.

Two Ways to Get Paid Speaking…

There are two ways to get paid when you speak -- either by being paid a fee to deliver a speech or by speaking for free in order to sell products at the back of the room. Typically, fee-based engagements require a lot of outbound telemarketing -- either by you or by your commissioned salesperson, which may include any speaker's bureaus that represent you. Speaking for free, on the other hand, makes "getting hired" much easier because you simply need to offer your services by phone -- or perhaps via a short written proposal letter -- to the person or organization holding the event.

If you're willing to speak for free or for low fees, a resource called www.SpeakerMatch.com can help connect you with hundreds of companies and organizations who are holding meetings and looking for speakers. You get to communicate directly with the person doing the hiring, so it's a lot easier to provide the organization exactly what it wants or needs.

There's no dishonor in speaking for free, by the way. This is particularly true if you can speak at a trade association meeting where everyone sitting in the audience represents a company who could buy your information product or pay for your advice.

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

Freelance Medical Writing Opportunities

2009-02-23T10:11:00.004-06:00

Away for the Week

2009-02-17T17:28:00.001-06:00

I'm in Colorado at a Writer's Conference. Coming back next week.

Webinar: Changing Regulatory Environment and its Effect on Biomedical Writing

2009-02-17T17:22:00.002-06:00

Free live webinar on Thursday, February 26, 2009 at 8:00PM EST: Changing regulatory environment and its effect on biomedical writing, with Dan Benau, Program Director of University of the Sciences in Philadelphia's graduate programs in Biomedical Writing.

Click here to register.

Health Communications Internship Program

2009-02-13T09:16:00.000-06:00

The National Cancer Institute (NCI), the largest of the 27 institutes and centers comprising the National Institutes of Health (NIH), is the Federal Government's principal agency for cancer research and training. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

The NCI recognizes that health information dissemination is key to raising public awareness about new cancer treatments, support for cancer patients and their families, and prevention strategies. To that end, in 1975 the NCI established the Health Communications Internship Program (HCIP) to attract individuals interested in careers in health communications and science writing.

The HCIP gives highly qualified graduate students and recent graduate school graduates the opportunity to participate in vital health and science communications projects in one of the many offices that make up the NCI. Interns will select an area of emphasis: health communications or science writing. Six-month and one-year internship terms are offered.

Successful health communications applicants have some science background as well as experience and/or education in any of the following areas: public health, epidemiology, public relations, health education, communications, science writing, statistics, social marketing, or journalism. Health communications interns:

* Plan, develop, and promote cancer education programs and materials (including Web-based) for the public, cancer patients, or health professionals
* Gain experience in pre-testing and evaluating cancer prevention and treatment messages, publications, materials, and programs that reach the American public
* Participate in professional meetings and training seminars

Successful science writing applicants have a science background plus experience in public relations and/or news writing with the ability to translate technical information into copy suitable for a lay audience. Science writing interns:

* Write fact sheets and press releases
* Answer inquiries from the press
* Attend and report on scientific meetings
* Participate in professional meetings and training seminars

The NIH main campus is located in Bethesda, Maryland. HCIP interns are placed in offices located in Bethesda or Rockville, Maryland. Both locations are accessible via public transportation.

More details here.

Medical Writing Position in San Francisco

2009-02-12T09:43:00.002-06:00

The Director of Medical Writing will be responsible for develop strategy for the content of documents to support clinical development and applicable sections of submissions to regulatory agencies (e.g., Protocols, Amendments, Investigator' s Brochure, Clinical Study Reports, IND Annual Reports, Briefing Documents, CMC updates, etc). Key responsibilities will include the management of the medical writing team, leading the Medical Writing function and overseeing the writing, preparation and editing of documents, ensuring that methods, results, and conclusions are appropriate.

The ideal candidate will have proven skills in writing and editing documents for regulatory submissions and publications, including interpretation and summarization of complex clinical data across multiple studies and phases. As well as proven management and organizational skills, including ability to understand, organize and supervise staff to work concurrently on several projects. Strong interpersonal skills and computer literacy are a must.

Preferred skill set includes a BS/MS/PhD in a life science discipline; 3-5 years in the pharmaceutical and/or biotechnology industries in regulatory medical writing including prior MAA / NDA. ECTD experience is preferred.

If you have any interest in further information regarding this opportunity, please forward your resume along with contact information to:

Lisa Madden
Associate Director, Recruitment
Delta Pharma, a Randstad company
Four Parkway North, Suite 120
Deerfield, IL 60015
T 262 302 0352
F 847 317 9543
lmadden@delta-pharma.com
www.delta-pharma.com or www.delta-pharma/jobs

Medical Writers and Readers

2009-02-09T11:08:00.002-06:00

It is said that to become a good writer, you have to read a lot. I agree.

Medical writers must keep abreast of what's going on in the biomedical field by reading journals, books on the trade and on science writing in general. One of my first models of what a medical/science writer could accomplish was Richard Preston with books like The Hot Zone and The Demon in the Freezer. These books got me hooked with the field of infectious diseases (in which I work now).

People often ask me what are some good books for medical writers. I recommend two: News and Numbers: A Guide to Reporting Statistical Claims and Controversies in Health and Other Fields and Health Writer's Handbook (and my ebook, of course!).

Anyway, because I'm preparing to move pretty soon, I've had to pack all my books. Ten boxes of books only so far. That's a lot to carry. There has to be a better way.

I haven't tried the Kindle yet, but I've heard good things about it. One option that I do like a lot is to listen to audio books on my iPhone. For that I got a subscription to Audible.com.

The format doesn't matter as long as you keep feeding your brain with good books. You'll be a better writer by the end of the day. Thanks for reading.

Medical Writing Job in England

2009-02-06T13:30:00.000-06:00

Medical Writer, Medical Communications, ENGLAND North West

Expanding Your Medical Writing Portfolio

2009-02-05T08:30:00.002-06:00

New medical writers interested in breaking into consumer health writing often face the challenge of obtaining good writing samples to showcase their writing skills. This is necessary to get an assignment at a top consumer health magazine.

One legitimate way of expanding your medical writing portfolio is by submitting articles to online health magazines or related Web sites. I just came across one such publication that accepts articles from freelance medical writers:

America's Medical Magazine

This is a web-based medical magazine dedicated to bringing the most compelling stories about the human side of any kind of medical condition to its readers. Accepted stories cover surgery, psychiatry, medicine etc from a provider, family, caregiver or individual perspective. You do not have to be an established writer to contribute to this magazine. Articles are non-fiction stories. Information articles are not solicited.

One time rights or reprints for electronic rights are bought as agreed with writers. Having your work accepted has more to do with the needs of the magazine than how good your write up is. The initial step is for you to send an email query with enough enough information about your proposed story. All initial communication is via email. You can send email to submissions@youandmemagazine.com

Your email should describe the nature of your story, how long it will take to complete and any other detail you feel is important. The magazine pays 5 cent per word. Payment is made on acceptance. Listing source here.

Interesting Seminar on Another Type of Medical Writing

2009-02-02T09:52:00.002-06:00

It's not unheard of medical writers who venture into fiction land, or physicians who become poets or novelists. In fact, there is a physician here on our campus who recently published a medical thriller, The Blood Notes of Peter Mallow.

What I hadn't heard of yet was that there are special seminars for MDs with literary inclinations. Well, it seems like SEAK has been doing such a thing for a decade. In 2009, they will hold the 10th Annual Fiction Writing for Physicians Conference, featuring two best-selling physician authors. Check their site here.