Friday, October 29, 2010


Job postings and other articles are now being published at the 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.

Thursday, October 7, 2010

AMWA 2010 Annual Conference

November 11-13, 2010 - Milwaukee, WI

Tomorrow is the dealine to register for workshops for credits.

Regsiter here.

Friday, August 20, 2010

Two new CME PDF's for medical writing

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.

Tuesday, August 17, 2010

2011 - A New Career Direction for YOU?

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.

Monday, July 26, 2010

2010 AMWA Annual Conference registration is now open!

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.

Thursday, July 1, 2010

Webinar to discuss the new AMWA curriculum

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

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

Thursday, May 13, 2010

Becoming a Medical Writer Indian Edition

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.

Monday, April 5, 2010

Scientific Medical Writer Position

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.


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


John Peace
P: 215-750-7500 F: 215-750-1398 C: 215-630-6848

Regulatory Writing Position

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.


If interested, please forward résumé and salary requirements to

Medical Communications Position

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.

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

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

Wednesday, February 10, 2010

PLx Pharma - Seeking Contract Medical Writer

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), attaching a work summary or resume/CV.

Friday, January 22, 2010

Free CME Webinar

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.

Thursday, January 7, 2010

Contract Medical Writer in Dallas/Fort Worth

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.

- 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

- 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


Jill Vandergrift
Precept Life Sciences
Subsidiary of Cambridge Global Services
727.812.3383 office
800.436.2212 x264 toll free
703.439.2482 fax

Monday, January 4, 2010

AMWA Southwest 2010 John P. McGovern Award Banquet and Lecture

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 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:
● Your name
● Your e-mail address or daytime phone number
● Your AMWA status (member or nonmember)
● Your meal option (dinner or dessert/coffee only)
● Your choice of dinner entrée (dinner option only):
● Pasta primavera (vegetarian)
● Chicken Acapulco
● 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