Chapter Officers & Volunteers
President: Richard Mateosian
VP Programs: Linda Urban
VP Membership: Jim Dexter
Treasurer: Nicolette Davis
Past-President: Joe Devney
Elections: Richard Mateosian
Recognition: Need volunteer!
Employment: Caroline Scharf
Public Relations: Need
Volunteers: Richard Mateosian
Education: Need volunteer!
Webmaster: Jim Dexter
Member-at-large: Patrick Lufkin
Chapter Job List:
Address, phone, or email changes:
Technical communication is the bridge between those who create ideas and those who use them. Conveying scientific and technical information clearly, precisely, and accurately is an essential occupation in all sectors of business and government.
The Society for Technical Communication (STC) has members worldwide. Its members include writers and editors, artists and illustrators, photographers and audiovisual specialists, managers and supervisors, educators and students, employees and consultants.
STC strives to:
Membership is open to everyone. Classic membership is $215/year. STC also offers Limited, E-Membership, and Student Membership options. To receive additional information and an application form, email firstname.lastname@example.org
Members of STC can apply for health, disability, and other insurance at STC group rates. For more information, see http://stc.org/membership/, contact STC office at email@example.com, or (703) 522-4114.
STC's annual conference brings together more than 2,000 technical communicators from around the world for educational programs, seminars, and workshops conducted by experts in the field. Annual conference: Dallas, Texas, May 2-5, 2010. In addition the STC sponsors many regional conferences, which feature the same sorts of programs, seminars, and workshops on a more intimate scale. STC sponsors international and regional competitions in all aspects of technical communication. STC Special Interest Groups (SIGs) bring together members with common experiences and interests to share their skills and knowledge. STC SIGs include:
STC sponsors research grants and scholarships in technical communication.
STC publishes the quarterly journal Technical Communication, the newsletter Intercom, and other periodicals, reference materials, manuals, anthologies, standards, and booklets.
Formed in 1953, STC has today become the largest professional society in the world dedicated to advancing the theory and practice of technical communication.
The six northern California chapters of STC conduct a variety of individual and joint activities. These and a list of other local organizations in which STC members may be interested are included in the Ragged Left.
This newsletter is free to members of the Berkeley chapter.
The Ragged Left is not accepting advertising at this time.
Ragged Left publishes original articles and illustrations. We edit them to meet our needs. You retain copyright but grant every STC publication royalty-free permission to reproduce the article or illustration in print or any other medium. Please talk with the editor for details of how to submit articles and illustrations.
The deadline for unsolicited submissions is the last Friday of odd-numbered months.
Other STC publications are hereby granted permission to reprint articles from Ragged Left, provided such reprints credit the author and the specific Ragged Left issue, and a copy of any publication containing such a reprint is sent to the Ragged Left editor.
The newsletter for the Berkeley Chapter of the Society for Technical Communication
More authors, more perspectives!
We have the good fortune this issue to have not one but two articles on Nancy Katz Ph.D.'s talk on writing in the medical field! They are about the same presentation, but especially if you weren't there to hear the talk, I encourage you to read both, as each write-up touches on some different concepts and details. Thank you to our industrious writers who provide the content for the newsletter.
The regular schedule is to post the PDF the first week of every even-numbered month (it's a bi-monthly newsletter), so I need content the last week of January, March, May, July, September, and November to publish the first week of February, April, June, August, October, and December.
by Richard Mateosian
I have just looked at the latest membership information that STC headquarters makes available to the leaders of this chapter. It lists all STC members in Berkeley and nearby zipcodes. It lists those who are not members of our chapter as "unaffiliated." These are either members of other chapters or not members of any chapter. The report doesn't distinguish between those cases. Up until March 31 the report listed everyone who had paid through the end of 2009. As of April 1, the report lists only those members who have paid their 2010 dues.
At this time last year our chapter had 94 paid up members. This number grew to 107 by the end of 2009. As of April 10, 2010, we have 56 paid up members, down 40% from last April. Of the 107 members we had at the end of 2009, two are paid up STC members but are now listed as unaffiliated. STC has dropped the remaining 49 members from this report. Some of those members have left the area or have given up on STC. Some mean to renew but just haven't gotten around to it. Others, I suspect, would like to continue but can't afford or can't justify the dues.
STC's existence depends on renewals. Without STC we would not have a chapter, so renewal is important to us. Nonetheless, our emphasis at the local level is less on renewals and more on maintaining and serving our community. Trying financial times have led to substantially higher STC dues at the same time as many of us have seen drastic cuts in income. We don't want that situation to drive anyone away.
Our chapter meetings provide networking opportunities and information to help us all succeed as technical communicators. Our prices remain low -- with a good crowd we barely break even. If you haven't yet gotten around to renewing and you sign up at the member price, we'll take that as a sign that you're still with us, and we'll be happy to see you.
Beyond the Practitioners' Lore: Reading the Research
Presentation by Susan Becker
Notes by Romy Sinha
In the February chapter meeting, Susan Becker gave an interesting presentation on the role of research in Technical Communication. She explained how research strengthens our argument and why we should use research to support our thinking and writing.
As technical communicators, all of us are making constant decisions about how to write a particular document, which style to adopt, and so on, in our everyday work. Most of the time we base our decisions to adopt a particular style on corporate guidelines, departmental policies and our own education. But sometimes we base our decision on what seems right to us, and it serves us fine. However, at times, we are challenged to base our decisions on evidence. That is when research becomes important. The decisions we make based on our research strengthens our argument.
To many of us, research may bring memories of late nights and delving into myriad books, papers and endless surfing of websites. That may be true, but Susan explained how we can streamline research and make it fun and interesting.
Susan told us how she learned a lot about research while working on the NIST (National Institute of Standards and Technology) Style Guide for Voting Systems. She, along with Dana Chisnell, did extensive research while working on developing the Voting Systems Style Guide. Basing their work on research, Susan and Dana turned the confusing reference manual that the poll workers used into a user-friendly one, with clear and easy to follow instructions.
In her presentation, Susan explained how to:
Susan mentioned a number of sources that address the evidence basis for guidelines, including:
Susan showed us how research helps us to write a document grounded in reality, how it helps us to defend our reasons for writing that document the way we wrote it, and how it aids us in explaining our position in committee meetings.
Romy Sinha is a software developer with an inherent interest in the field of and Information Architecture. Romy has been a software developer and technical writer with Vertical Development Inc. for the last nine years. Romy is looking to leverage her software expertise and experience and transition fulltime into Information development.and
What does a medical writer do, and how can I become one?
Presentation by Nancy Katz, Ph.D.
Notes by Carole Baden
On March 10th, Dr. Nancy Katz answered these questions with an in-depth presentation on the role of the medical writer in the biopharmaceutical industry. Nancy has a PhD in English from UC Berkeley and was an educator and trainer before transitioning into the medical writing field, in which she has worked for over ten years. She is now the principal of Illyria Consulting Group, which referencing Shakespeare's Twelfth Night, "brings clarity and harmony to document confusion."
Nancy's talk began with a discussion of basic definitions, moved on to the deliverables and basic competencies that are expected from medical writers, and concluded with strategies for preparing to get a job in the field.
By way of introduction, Nancy answered the general question, what does someone in this field do? A common job title is "regulatory writer," and one of the main tasks of the medical writer is to create the applications for approval of new drugs that are filed with government agencies, such as the FDA. According to Nancy, biopharmaceuticals is the area within medical writing that has the most jobs and most significant income opportunities.
Medical writers provide documentation for a number of different studies. Clinical trials measure pharmacokinetics, how much/how long/how often a particular medication is needed, and pharmacodynamics, what a particular medication does in the body. Non-clinical ("pre-clinical") studies can include in vitro (in glass) and in vivo (in animals). Finally, Quality "CMC" (Chemistry, Manufacturing, and Controls) studies examine the production and chemical properties of new drug compounds.
What are the deliverables in this field? To begin with, these documents deal with data, so you should enjoy working with numbers even if you do not have mathematical/scientific expertise. The functions of the documents produced involve data collection (the study protocol) and data reporting (the final report of a clinical trial). They deal with issues of efficacy and safety. You will need to be familiar with the content of the reports you produce, even if you are not an expert.
Regulatory documentation includes study protocols; investigator brochures, which may include background on previous studies (animal or human) and information on side effects; and reports of clinical trials. The format of this documentation conforms to guidelines set by ICH (www.ich.org) a consortium of participating nations encompassing Japan, Europe, and the United States. Submissions to the ICH take the form of the Common Technical Document (CTD), a group of PDF documents organized into modules. When linked via an XML backbone, these documents are called the eCTD.
There are a number of competencies required in this field. A medical writer should be familiar with the standard structure for final reports of clinical trials (known as IMMRAD format), and also be familiar with the various elements of the eCTD. There are also standards for the tables and figures which present study results. In reviewing the final report, the writer should be familiar enough with the material to be able to point out inconsistencies between the results of a study and the conclusions drawn from that data. (In response to a question about the ethical implications of this, Nancy said that she has never had a researcher disregard her feedback about these kinds of issues.) The writer should also have a familiarity with biostatistics, processes and requirements for quality assurance, and regulations covering drug development.
Finally, the medical writer needs to have competencies applicable to technical communicators in general: flexibility, good project management skills, the ability to work effectively with a team, and being able to adapt to the in-house style and templates of various sponsors.
Nancy concluded with guidance for those wanting to transition into the field of medical writing. First, begin by identifying transferable skills, such as writing, editing, and software expertise. Next identify and plug the gaps in your knowledge. Additional competencies can be acquired via various professional organizations. AMWA (American Medical Writer's Association) has information about drug development and gives certification. Other organizations to explore are PERI (Pharmaceutical Education and Research Institute) and RAPS (Regulatory Affairs Professionals Society). Finally, and most importantly, be very straightforward when representing your skills and abilities to a potential employer.
Unsurprisingly, a key element of success in this field is networking. Resources include BABCN (Bay Area Biomedical Consultants Network) and AMWA (American Medical Writer's Association.) The DIA (Drug Information Association) has a Medical Writing Special Interest Area Community which offers information and classes. An informational interview with the medical writing director at a biopharmaceutical company could also be helpful.
Our speaker presented a lively and information-packed overview of the field that should provide useful guidance for anyone interested in taking the leap into medical writing.
Carole Baden is enrolled in the Professional Sequence in Technical Communication at the . She is learning to identify examples of great documentation wherever she finds them.
What Medical Writers Do
Presentation by Nancy Katz, Ph.D.
Notes by Jana Rollo-Fennick
Despite these times of economic uncertainty, forecasters say that medical and health care jobs are on the rise. For technical communicators, this could mean increased openings for medical writers. The medical writing field has many types of writing under its umbrella, including regulatory, medical education, marketing communications, policy and public health, medical and healthcare journalism, technical instructions, and grant writing.
Technical communicators interested in becoming part of this expanding field, or at least curious to learn more about it, gathered at the Highlands Country Club in March to hear Nancy Katz describe the regulatory aspect of this industry. According to Katz, regulatory writers are in demand even in these difficult times, and salaries are competitive.
In her presentation "What Medical Writers Do", Katz defined what a "regulatory writer" is, explained the expected deliverables, discussed the basic competencies necessary to be successful as a regulatory writer, and recommended strategies for breaking into the field.
The main job of regulatory writers is to produce documents about new drugs that will be submitted to regulatory agencies for approval. This will include such documents as protocols, amendments, study reports, integrated summaries, briefing packages, investigator brochures, and high-level summaries of the quality, nonclinical, and clinical documents submitted in a drug application.
Katz described the various facets that are studied in clinical trials, such as:
The goal of the clinical trials is to determine the least amount of the drug needed to produce the desired result with the least amount of side effects.
In conjunction with a filing team, regulatory writers gather documentation for approval of a new drug into a template known as the CTD (Common Technical Document), which consists of 5 modules, and submit it to a regulatory agency. The CTD is a collection of PDF documents linked together by an XML backbone. Electronic CTD submission (eCTD) is now the preferred submission method by the FDA, the U.S. regulatory agency, because it provides reviewers instant access to all supporting documents, allows transparency and traceability, and facilitates review.
Basic competencies for writers in the medical field
In order to produce the deliverables, there are some basic competencies that a regulatory writer must possess.
You must be comfortable working with a lot of numerical data ("TFLs" – tables, figures, listings). You need to have a good "feel" for the data, and be able to translate the data into a message – an accurate qualitative statement. Katz provided examples of both "good" and "bad" messages to illustrate her point. She also pointed out that you must have an intuitive awareness if a message or statement provided to you is correct.
You must have a working knowledge of statistical tests used in clinical trials.
Regulations and guidelines
You must be familiar with relevant sections of:
You must have knowledge of the standards contained in:
Formats and templates
You must be able to write documents, often based on sponsor-approved templates, which are in accordance with the CTD format.
Develop case for drug
You must be able to write the report that builds the case for the drug. In addition to writing the introduction, describing the methods and materials, presenting the results, and discussing the conclusions, you will need to deal with any weaknesses of the drug and emphasize its strengths.
You must be able to manage multiple projects and timelines, and be good at troubleshooting.
You must be able to effectively reuse or "repurpose" documents.
You must have the flexibility to be able to adhere to style manuals (e.g. the AMA Style Guide or the Chicago Manual of Style) while also conforming to the eccentricities of your sponsor's style.
You must be proficient at teamwork. It is essential to work closely with key team members such as physicians, biostatisticians, personnel from Clinical Operations and Regulatory Affairs, as well as nonclinical people. Strong interviewing skills is essential.
You must understand and anticipate Quality Assurance processes and requirements.
For those who have the desire to pursue a career as a Regulatory Medical Writer, Katz offered several strategies. First, learn about drug development. The American Medical Writers Association (AMWA) offers education and certificate programs. Next, understand the structure, content, and regulations of the CTD (and eCTD). Then begin the transition – but only if you are committed to this work! This is not something you can just do on the side.
To begin the transition, identify your transferrable skills such as writing, editing, software expertise, and Quality Assurance experience. Identify and plug the education gaps. Once you have done this, start networking by attending professional meetings, arranging for informational interviews, and taking advantage of online networking via Linked In, Plaxo, or BABCN (Bay Area Biomedical Consultants Network).
According to Katz, there is a real need for good Regulatory Medical Writers. She acknowledges that breaking into the field is tough, but if you are committed to it and willing to prepare yourself, it IS possible!
Nancy Katz, Ph.D., is President and Principal Medical Writing Consultant of Illyria Consulting Group, Inc. (www.illyriaconsulting.com). Illyria provides writing services for the biopharmaceutical industry, specializing in documents for eCTD-based submissions.
Nancy recently completed a 4-year term as a core committee member of the DIA (Drug Information Association) Medical Writing SIAC (Special Interest Area Community) and now serves on that SIAC's E3 task force. She is a member of the pharmaceutical content subcommittee of OASIS (Organization for the Advancement of Structured Information Standards) and mentors writers through AuthorAid, an organization that helps researchers in developing countries publish their work.
Jana Rollo-Fennick has over 10 years of Technical Writing experience as part of the Pharmacy Systems IT team at Longs Drugstores Corporate Office. Recently, Longs was bought by another company and all the Corporate Office jobs were eliminated, so she is actively seeking work elsewhere as a Technical Writer. She has developed a variety of documentation for multiple audiences, and is trained in Information Mapping concepts and formats. She is also a community volunteer and a trained Disaster Service Worker with CORE (Communities of Oakland Respond to Emergencies). For more information about Jana, please visit her VisualCV website, http://www.visualcv.com/hdjohkp.
Thinking about the usability of a CMS
by Eric Hughes
Most of the usability work I've done has been for customer-facing sites. But behind those sites can be sophisticated systems for authoring, editing, approving, publishing, and security. Recently, I've been working on a project to test how well a rather complex content management system (CMS) works. It is interesting how different this analysis is from your typical customer-facing site, where the first thing you do is develop audience personas. On customer-facing sites, nothing can be measured or analyzed without understanding audience characteristics and their business, but on CMSs, everything is much more task-driven and less influenced by audience needs. This is not a good thing, it is just the way the priorities fall.
The audience for the CMS I am evaluating are content authors and editors, content approvers, and publishers; this is pretty typical. Some are business people and some are technical; again, pretty standard. The CMS is used not only to create and publish content, but to assign and manage who is authorized to access certain areas and applications on the client's extensive and mission-critical web presence.
Content management systems work the same way as any other web site: there are interfaces, applications, content, and performance concerns. But CMSs are different in these very important areas:
There are challenges to testing an environment like this:
I get questions quite often from cohorts about content management systems. The most common question is: "so is there one of these things the non-savvy user can figure out easily?" And the answer is always: "well, not really, but there certainly could be if someone were willing to split up the toolbox into individual tools!"
Eric Hughes has been an STC member since 2004. Things that don't work the way they should drive him crazy. You can reach him at firstname.lastname@example.org; or on Twitter, FaceBook, LinkedIn, and delicious at /hughese
Our chapter holds a dinner meeting the second Wednesday of each month. In addition to listing upcoming meetings, this section includes:
Developing and Delivering Documentation in a Wiki
by Dee Elling
Wednesday, April 14, 2010, 6-9:30pm
Highlands Country Club
Over the last 2 years, Embarcadero Technologies went through the transition from authoring their developer documentation in XML/DITA and publishing to Microsoft Help2, to writing and publishing their content using MediaWiki. Dee Elling will talk with us about what led to that decision, and what their experience has been. She will talk with us about:
Dee Elling is perpetually
curious. She is always looking for new ways to meet the changing needs
of web-centric customers. She is interested in lean development, rapid
iteration, customer engagement and collaboration, and in growing self-motivated
and technically-savvy teams.
Design to Read: Designing for People Who Do Not Read Easily (a report from the CHI 2010 workshop)
by Kath Straub
Wednesday, May 12, 2010, 6-9:30pm
Highlands Country Club
This year at CHI 2010, Kath Straub is participating in the workshop Design to Read: Designing for People Who Do Not Ready Easily. She will report on her experience and the ideas generated in this day-long workshop.
If you are not familiar with CHI workshops, they provide a venue where professionals with common interests can discuss and explore a particular area of interest. Workshops often move an area of study forward, and can result in additional research or writings. For more about CHI workshops, see http://www.chi2010.org/authors/cfp-workshop-participants.html.
Kath Straub works with organizations and agencies to create, integrate, and evaluate interactions and content. Usability and Content strategy are both key elements of this effort. To ensure that sites are both usable and useful, Kath also focuses on how to create meaningful small talk that engages users via readable and persuasive content to drive behavioral change.
Kath is an energetic and entertaining speaker who presents frequently at conferences and workshops around the world. Recently, she has presented in Atlanta (CHI), Berlin (UPA), London (TecCom), and Austin, TX (GTC). She's currently the Principal of Usability.org. Prior to that, she spent 9 years as the Chief Scientist at Human Factors International. Kath holds a Ph.D. in Brain and Cognitive Science from the University of Rochester.
Reserved on the Chapter's website by the day prior to meeting.
Meeting and dinner
At the door (no reservation)
Meeting and dinner
Note: If you do not reserve dinner in advance, dinner may or may not be available on a walk-in basis. We order dinner for the number of reservations plus a few walk-ins.
Special cost notes
* Attendees, please announce open positions, and bring job listings for distribution.
Recruiters are welcome to attend meetings, place literature on a designated table, and talk with attendees one-on-one during the informal parts of the meeting. We ask them not to announce specific jobs during the formal announcement period, but they are free to stand up and identify themselves.
Similarly, we ask anyone else with commercial announcements to confine themselves to calling attention to the availability of literature on the designated table.
Highlands Country Club
In this issue
Increase your network and net worth—join STC today!
The Society for Technical Communication (STC) advances the theory and practice of technical communication across all user abilities and all media. For more information about STC, send an e-mail to email@example.com or visit www.stc.org.
Leadership Positions Available
We are looking to fill several leadership positions! Contact Richard Mateosian if you are interested. See http://www.stc-berkeley.org/VolunteerOpportunities/volunteer.shtml for a list of open positions.
Regional STC News
T. R. Girill gave a talk to our chapter in December (see write-up in the Jan/Feb 2010 Ragged Left) on some literacy outreach activities.
A year-long http://www.ebstc.org/newsletter/0310/Article_4.htm.
Other STC chapters in Northern California
East Bay: www.ebstc.org
North Bay: www.stc-northbay.org
San Francisco: www.stc-sf.org
Silicon Valley: www.stc-siliconvalley.org
American Medical Writers Association (AMWA) of Northern California. Meets periodically at various Bay Area locations. www.amwancal.org
American Society for Training and Development, Mount Diablo Chapter. Meets monthly in Danville. http://mtdiabloastd.org/.
American Society of Indexers, Golden Gate Chapter. www.asindexing.org/site/chapters.shtml#golden
Association for Women in Computing, San Francisco Bay Area chapter — www.awc-sf.org/
International Association of Business Communicators, San Francisco chapter. A network of professionals committed to improving the effectiveness of organizations through strategic interactive and integrated business communication management — http://sf.iabc.com/
National Writers Union (UAW). A labor union for freelance writers of all genres. — www.nwu.org
Northern California Science Writers' Association. Quarterly meetings & other events. www.ncswa.org
Seven tips to improve your writing
WRITER'S WEB WATCH, Issue No. 114, March 2nd, 2010, http://www.WritersWebWatch.com
Writers must keep pushing to improve and to stay interested. Here are some ways to do both.
SOURCE: WRITING THAT WORKS, our print-only, bimonthly newsletter. Nonsubscribers may sign up online for a free trial subscription at: http://www.writingthatworks.com/freetrialsubscription.htm
Web writing advice
WRITER'S WEB WATCH, Issue No. 114, March 2nd, 2010, http://www.WritersWebWatch.com
The Web requires better, different writing.
Writers need to make some adjustments, Bloom says. The tone must be
much more informal, conversational, colloquial. Often you write in first
person rather than third and provide links to additional information.
Copyright your web site
From the WRITER'S WEB WATCH, Issue No. 115, March 10th, 2010, http://www.WritersWebWatch.com
When you put original content in print or on the Web, you automatically
have a copyright that is protectable, but don't expect to win damages
for copyright infringement if you haven't filed with the Library of Congress,
says Harvey Jacobs.
The Ragged Left is published six times a year (every other month).