3 July 2009                 Published weekly by Biotech Ink, LLC Vol 2 No 19

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Cool Find: FREE eCTD Templates and Submission Readiness Evaluation
by Susan E Caldwell
 
 
(Original post by Susan E Caldwell, 26 June 2009, in Biotech Ink Spots blog)
 
Angel Bivins photoA quick post about a very cool find. iRegulatory, a regulatory consulting firm in the UK, has an eCTD Resources page on their web site. If you go there, you will find two very useful tools.
 
A free and complete set of eCTD templates, in Times New Roman font, that appears to be fully ICH complaint at first blush (although I have only checked a few of the templates). The templates cover the Master Table of Contents and the content for Modules 2 through 5. In addition, there is an accompanying style guide as a PDF file.
 
A free online survey tool on the same page lets you evaluate your submission readiness. That is, it helps you determine whether you and/or your company are truly ready to submit your product's market application for approval. The survey asks many detailed questions that focus on your document management system (if you have one) and version control of submission documents. Another topic covered in the survey is how adept your writers are when using Microsoft Word's intermediate and advanced features.
 
I've been the lead medical writer on 6 eCTDs, including ~ 15 NDAs and BLAs, and several INDs. Based on my experience, I think that companies facing a looming FDA or other regulatory submission would greatly benefit from downloading the template-and-style-guide package and taking the survey. These simple tools could save much grief and financial loss down the road.
 
Caution signA caveat, though: I recommend that you should do a careful evaluation of the templates and style guide against the ICH Guidelines before using them. After all, there is a great deal of time, money, and hope to be invested in your eCTD, NDA, and/or BLA submission(s). Prudence tells me that a thorough check of the templates and style guide would be well worth the effort, if nothing else, for peace of mind.
 
About the Author

Susan Caldwell is a medical writer, PhD scientist, general writer, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, web content, brochures, white papers, conference summaries, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008.

You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).

Copyright 2009 Biotech Ink, LLC. All rights reserved.
 
Open Jobs and Gigs for Medical Writers

The jobs listed in the Biotech Ink Insider come to us mostly by word-of-mouth and direct contact with hiring managers and recruiters. If no new jobs are communicated to us in a given week, the Insider won't be published that week. See also our disclaimer at the bottom of the newsletter.
 
If you're a writer or editor and are getting calls about staff or contract positions you aren't interested in, please forward that job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider.
Contract Clinical Scientist/Medical Writer
South Bay, San Francisco Bay Area
 
This is a 1-year contract in the South Bay, CA. We are looking for someone with around 2-3 years experience as a Clinical Scientist or Clinical Researcher, rather than an extensive work history.  The contractor will be involved in supporting a clinical trial and reporting submissions to the FDA. This person will participate in preparing presentations, abstracts, and data mining for new analysis by conducting meetings with appropriate departments and individuals.
 
Required Skills for this position:
 
1.  Clinical Scientist (or Researcher) with a very "STRONG ABILITY" to write.
2.  Must have a writing sample submitted with resume per manager's request.
3.  MUST be familiar with Clinical Trials and medical documents.
4.  Candidate must have a PhD to be considered for the position.
 
The start date is ASAP and will go through one year. Pay is hourly on a W-2. Only SF Bay Area candidates or those in the close proximity will be considered.
 
For immediate consideration, please email a copy of your complete Word-formatted resume to Jenny at Jjongejan@techlinksystems.com
 
Thanks,
 
Jenny Jongejan
Senior Recruiter/Acct Mgr
TechLink Systems, Inc.
San Francisco, CA
415-732-7580 x140
http://www.linkedin.com/in/jennyjongejan 
(Please click on my profile to keep in touch on LinkedIn!)
In-House Contract Medical Writer
Cambridge, MA
 
In-House Contract Medical Writer position for a Pharma company in Cambridge, MA

Responsibilities
  • Responsible for writing and editing high-quality manuscripts, posters, presentations, review articles, slide kits, and other educational materials from clinical study data
  • Proofread layouts of publication materials, including galleys
  • Organize and facilitate monthly meetings, providing relevant publication and communication updates
  • Provide review and substantive editing of documents
Qualifications
  • A minimum of 3 years of experience writing/preparing abstracts, manuscripts, and reviews for clinical trials for a pharmaceutical, biotechnology, or contract research company
  • Must have a strong science background
  • Prior experience in the therapeutic areas of oncology, hematology, bone marrow transplantation is highly desirable
  • Able to research and review clinical content effectively and translate information into clear and concise messages using AMA style in the English language
  • Candidates must possess a BS or higher degree in a scientific discipline
  • Masters or PhD degree in any Biomedical Science highly preferred
 
If interested, please contact:
 
Marjorie Saraga
Senior Staffing Specialist
The Clinical Resource Network
260 Madison Avenue - 3 rd FL
New York, NY 10016
Toll free: 800-230-8717
Local:     212-824-1598
Fax:       212-824-1599
Biotech Ink's Links
 
Biotech Ink Spots medical writing blog
 
Biotech Ink Insider medical writing newsletter information web site 
 
Biotech Ink Insider medical writing newsletter archives
 
 
Susan Caldwell's Medical Writing Twibe (a special-interest Twitter group; Twitter account required)
 
Comments or questions? Email Susan at caldwell@biotechink.com.