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May 29, 2009 | Vol. 2 No. 15 Published by Biotech Ink, LLC | |
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Inside the Insider
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Editor's Picks: Tools and Fun for Writers, by Susan E Caldwell, PhD |
Setting Microsoft Word Options to Preserve Your Sanity, by Peter G Aitken, PhD, and Maxine M Okazaki, PhD |
My Tips for Effective Use of LinkedIn, by Mitch Gordon |
Associate Scientific Director, Medical Communications; San Bruno, CA |
Medical Writer/Senior Medical Writer, Chicago, IL |
Medical Writer, Cincinnati, OH |
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Editor's Picks: Tools and Fun for Writers
by Susan E Caldwell, PhD |
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WatchDox - this free browser-based service allows users to securely share and work with documents over the internet. You upload your documents to the WatchDox server, and you have full control over who sees them. Additionally, you will know which documents are opened and by whom.
 Buzzword - Available online since 2007, Adobe's free online word processor (beta). There are three possible roles with a Buzzword document: coauthor (has full writing/editing access), reader (reads, but can't edit), or reviewer (reads and can leave comments, but can't edit). Access your documents from anywhere, collaborate in real time with others, and--the best part--it offers version control. Imports and exports plain text (TXT), rich text format (RTF), Microsoft Word (.doc and .docx), Word 2003 XML, and Open Office (.odt) files, and exports to Adobe PDF, HTML and epub.
Baralga - More time tracking software! This free app lets you know how much time you've spent on your projects. Recommended for consultants, contractors, and other folks who need to account for their time, it's lightweight and easy to use.
Rachota - If you don't like Baralga, Rachota is also a time tracker. It's portable - runs on any USB drive, so you can take it with you. Has a nice pause function for those coffee breaks, and runs on Mac, Linux, and Windows.
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About the Author
For 20 years, Susan Caldwell has worked in the biotechnology, pharmaceutical, and medical device industries. Her experience includes drug discovery, preclinical and clinical research, process development, and drug and medical device manufacturing. Since 1995, she has been a medical writer, and has directed writers and editors at five companies. Her specialty is writing and editing regulatory documents, such as eCTDs and clinical research documents. Susan is managing editor of the Biotech Ink Insider, a publication of Biotech Ink, LLC. You can follow her on Twitter and see her profile on LinkedIn. |
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Setting Microsoft Word Options to Preserve Your Sanity
by Peter G Aitken, PhD, and Maxine M Okazaki, PhD |
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Microsoft Word is a very powerful program, packed with features that are designed to make the writer's job easier. Sometimes, however, these features can get in the way and make your job harder, particularly if you don't know what the feature is or what it does. Our approach to using Word is to give the writer the maximum control over the document. This means turning off certain Word features that can cause unwanted and unexpected changes in your document, leading to wasted time and an increase in your gray hair ratio. In this article, we'll explain two of these features and why you should disable them for all your writing. This is relevant for all versions of Word since Word 2002. Have you ever had formatting throughout your document change without apparent reason? The culprit may have been the Prompt to Update Style feature. As you probably know, each paragraph in a document has a style assigned to it; this style defines the formatting of the paragraph-its font, font size, line spacing, indentation, text color, and so on. By default, paragraphs have the Normal style, but most documents use other styles, either Word's built-in styles or ones defined by you - for various document elements such as headings, sidebars, and captions. When the Prompt to Update Style feature is active, Word automatically updates a style definition if you change the formatting in the document. For example, suppose you have a style called Sidebar that is Arial 10-point font, and there are 15 paragraphs using that style in the document. If you select one of those paragraphs and change it to Times 12-point font, Word will automatically change the style definition to Times 12-point font. As a result, all the 14 other Sidebar paragraphs in the document will also change to Times 12-point font. This is rarely what you want! To turn this feature off, display the Options dialog box and, on the Edit tab, make sure the Prompt to Update Style option is not checked. Another supposedly helpful Word feature is Keep Track of Formatting, but in our experience it is just another annoyance. This feature is to blame when you find your list of styles becoming bloated with style names such as Body Text + Italic and Normal + Bold, Underline. When Keep Track of Formatting is active, Word automatically creates a new style when you change formatting in the document. Suppose you have a paragraph that is formatted with the Normal style, and you italicize one word in that paragraph. Word will create a new style called Normal + Italic and add it to your list of styles. The result is usually a style list that is bloated with styles that you'll never use. We suggest turning this off-you'll find it in the Options dialog box right under the Prompt to Update Style option. These are just two of Word's features that can make you think there's a gremlin in your computer. While some people may find them useful, we believe they should be turned off at all times because the often stringent standards for medical writing documents require that the writer maintain maximum control over his or her document. ________________________________________________________________________________________ About the Authors
Dr Peter G Aitken Dr Maxine M Okasaki
 
This article is excerpted from Peter and Maxine's book, Microsoft Word for Medical and Technical Writers ( www.tech-word.com). Peter and Maxine are the principals of Piedmont Medical Writers, LLC, in Chapel Hill, North Carolina ( www.PiedmontMedicalWriters.com). |
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My Tips for Effective Use of LinkedIn
by Mitch Gordon |
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There's hardly anyone in the professional world, whether a job seeker, a freelance, an employee, or a manager, who hasn't been urged to get listed on LinkedIn. LinkedIn is widely seen as the social networking website of choice for professionals. It has over 41 million members (according to its About Us page) and a phenomenal rate of growth. It's probably safe to say that the majority of people you know in your field are on LinkedIn, or will be soon. Nevertheless, many people get registered on LinkedIn and ask themselves questions like these: "What am I doing  here?" "What do I do next?" "How does this site help my job search or business?" "How much information do I really want to publicize about myself on the web?" My goal in this article is to give you my own answers to these questions based on my LinkedIn experiences. Registering on LinkedIn doesn't accomplish anything by itself--it is a tool, and there are ways to use it effectively in support of your goals. There are many features in LinkedIn, and some will prove more valuable to you than others. You need to experiment and find out what works for you, and ask others how they use it. For some ideas on how to use LinkedIn, be sure to read Susan Caldwell's article in a previous issue of the Biotech Ink Insider: The Job Hunt Part 2: Business Networking Sites. Here are my tips for effective LinkedIn use. Think of LinkedIn as a searchable database of resumes. In LinkedIn, each person creates the equivalent of an online resume or CV--their profile. In addition to standard resume information, your profile includes your photo, recommendations from coworkers or supervisors, website links, and so on. Setting up your profile makes it visible to searchers. When someone performs a search in LinkedIn, sees your name in their list of results, and clicks on it, your profile appears. For example, let's say I once worked for the First National Bank of Podunk as a branch manager, and I've included that in the Work Experience section of my LinkedIn profile. Let's also say that another LinkedIn user performs a search for people with "branch manager" in any of their job titles (past or present) who are located within 100 miles of Podunk. Voila! My name, photo, and summary information come up in that searcher's results list. The searcher clicks on my entry in the list, and what they see next is my profile--that is, my resume--displaying, among other things, the work experience entry for the 3 years I spent managing that bank branch.
The power of LinkedIn lies in its searchability. You can search for people using a variety of criteria, alone or in combination, such as name, job title, keyword string, company where employed, schools attended, location, industry, or professional associations. For example, I want to re-establish contact with a quality engineer named Alicia that I met at the American Society of Quality (ASQ) meeting in Berkeley last month, but I don't remember her last name. I could search for people with a first name of Alicia who belong to ASQ, or Alicias that live within 50 miles of Berkeley and have Quality Engineer in their title, or something similar. The search results list from my search for Alicias will display one entry for each, providing her full name, photo, current job description, industry, and region. If I've defined a narrow enough set of criteria the list of results should be short, and I should be able to figure out which Alicia I am looking for from each person's summary information and photo. Then I click on her entry to get to her profile.
Don't be stingy with your information. I've seen LinkedIn profiles that leave out the person's past positions, degrees, job descriptions or accomplishments. I've even seen a profile that omitted the person's name! Although I realize that people have varying levels of comfort with having their information on the Web, I don't advocate holding back information in your profile--include anything you'd put in a resume (other than contact information). If you're in LinkedIn, you're there to search and be searched for. Think of it as the Golden Rule of LinkedIn profiles: post as much information about yourself as you would want to see about someone else. In addition to keeping LinkedIn useful for everyone, it also benefits you directly by improving your searchability.
Join LinkedIn groups. Searchers sometimes specify membership in a particular LinkedIn group or groups as a criterion in a search. Therefore, if you belong to that group, you'll come up in that person's search, so this is a good reason to belong to a variety of LinkedIn groups. You should definitely join LinkedIn groups that parallel real-life professional groups that you belong to. For example, if you are a member of the American Medical Writers Association, you should join the AMWA group on LinkedIn. There are also LinkedIn groups that don't have a parallel outside of LinkedIn. If these are relevant to what you do, join these, too. In addition to making you visible in searches, group membership gives you an avenue for contacting people you don't know, as I'll explain next. However, I don't subscribe to group emails, since I don't generally find the messages posted on any of my LinkedIn groups useful (your experience may differ).
Use a LinkedIn Invitation to make contact when you don't have someone's email address. Often you want to contact someone who appears in the results list from one of your searches. However, LinkedIn won't let you see someone's email address or email them through the site's internal mail system, unless he or she is one of your connections. This can be a significant obstacle--the point of a search is usually to find people to contact that meet certain criteria, such as working for a company of interest to you or having certain qualifications. How do you contact them? Here's how: invite the person to become one of your connections and treat the invitation notice as your email to them.
To do this, bring up the person's profile and click the "Add Edward Executive (or whomever) to your Network" link at upper right. You're prompted for the following: 1) how you know Edward, and 2) what you want to include as a "personal note" in your invitation to him. Some of the "How do you know Edward" options are more restrictive than others (for example, if you say you're a colleague, LinkedIn will require you to specify at which of your former companies you worked together) so I generally choose "Groups and Associations" selection and pick a relevant group. Here's where belonging to groups is handy!
Next, compose your "personal note" with everything you want to say to the person you're contacting. The default personal note is "I'd like to add you to my professional network on LinkedIn." Replace this with a paragraph that describes you and explains exactly why you're contacting the person. For example, in the early stages of my career change to freelance medical writing I was searching for people in my field that I could ask for informational interview phone calls. I'd search in LinkedIn for medical writers within 50 miles of San Francisco, or similar. Then I'd look at each profile from the search, decide if I wanted to ask the person for an informational interview, and make my pitch in the invitation, which included my email and phone number. I made a number of excellent contacts this way and I was able to get around the fact that I didn't start out with an email address or phone number.
Use the Summary area of your profile to make a pitch for yourself. Marketing is important to the success of both job seekers and freelances. You need a succinct elevator speech when you meet people face-to-face and a cover letter that highlights the key points of your qualifications when you send a resume. Similarly, the Summary section of your LinkedIn profile should make the case for why you're an ideal person to hire or contract with for work in your field. You have plenty of space here and it's very prominent in your profile--you should take advantage of it.
Periodically update your "What I'm doing now" statement. This applies to freelance writers--it's not really necessary for people with staff positions. Describe what kinds of projects you're working on. When you get a new project, replace your statement. This is useful because it's the first thing someone sees on your profile. Also, when you replace the what-I'm-doing statement, the people in your immediate LinkedIn network (your connections) are notified. It's a way to periodically get noticed by people you're connected with, reminding them of who you are, and keeping them up to date.
Those are my LinkedIn tips. I hope they'll prove useful to you. Best of luck finding what (and whom) you're searching for!
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About the Author
 Mitch Gordon has been a professional technical writer in the software and other industries for 16 years, and is now a freelance medical writer. He is working on his Masters degree in Regulatory Affairs, to be completed in early 2010. His specialties are regulatory and clinical documentation, medical device and diagnostics manuals, training materials, journal articles, slide shows, and posters.
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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. |
| Associate Director, Medical Writing
San Carlos, CA |
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The Associate Director of Medical Writing will have overall responsibility for all medical writing activities, including preparation of clinical protocols, Investigator's Brochures, and contributions to the preparation of key regulatory documents, including INDs, NDAs, and annual reports. The candidate must also be familiar with document management software and able to facilitate new standards and necessary infrastructure to meet the development needs and objectives of the organization. Preparation of abstracts, posters and manuscripts is also a requirement. Manages the medical writing function and staff.
Responsibilities:
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Works on problems of diverse scope, in which analysis of data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques.
- Manages all clinical writing activities outlined in the Project Clinical Development Plans.
- Reviews documents, offers guidance, and takes lead in mentoring writers in the preparation of regulatory and publication documents.
- Organizes, conducts, and leads document production meetings and other meetings as necessary.
- Projects Medical Writing budget, resource, and timeline requirements for CDP.
- Responsible for timeline management, budget and managing outside vendors on regulatory document writing projects.
- Responsible for developing and managing Departmental Guidelines management system, Writing style guide, and departmental templates, such as protocols, Investigator's Brochures, final clinical study reports, IND sections.
- Proposes applications.
- Provides and manages internal and external writing activities.
- Responsible for developing department infrastructure, such as contributing to research, acquiring a document management system, establishing style guides, and generation of templates and processes.
- Manages internal staffing and performance management, including hiring, training, coaching, and performance reviews.
Requirements:
- Education: Bachelors/Masters degree in a scientific discipline with a strong background in pharmaceutical drug development is required. A PhD in a scientific discipline is highly desirable. Journalism background is required. quivalent experience may be accepted.
- Minimum of 8 to 10 years in a pharmaceutical, biotech, or CRO medical writing position is required.
- Minimum of 6 years writing management experience is also required. Minimum of 5 to 8 years previous supervisory experience is required.
- The ability to create effective presentations from raw data is essential.
- The ability to interpret statistical and clinical data is essential.
- Must have the ability to work well with others in high-pressure situations.
- Must have demonstrated problem solving abilities.
- Strong organizational skills are required.
- Strong written and verbal communication skills are required.
- An understanding of clinical research, biostatistics, and regulatory affairs is required.
- Must have experience writing clinical protocols, clinical study reports, and IND sections.
- Good computer skills are required. Working knowledge of MS Word, Excel, PowerPoint, and use of document management software is a requirement; experience with Lotus notes is a plus.
Contact:
Judie Sampson
Sampson Medical Search
13234 Fiji Way, Unit F
Marina del Rey, CA 90292-7061
Phone: (310) 305-8468
Fax: (310) 305-8612
E-Mail: sms_resume@earthlink.net
E-Mail: sampsonmed@aol.com
Website: www.sampsonmed.com |
| Medical Writer/Senior Medical Writer
Chicago, IL |
Objective:
Executes medical writing activities for projects in accordance with applicable US and international regulatory regulations and Company requirements under the supervision of the Manager, Medical Writing. Assumes primary responsibility for preparation of regulatory response documents and documents supporting major regulatory submissions, under the direction of the manager. Participates on relevant project teams and task forces, and provides guidance to clinical, safety, nonclinical, and CMC functions on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, Company requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
Required Qualifications:
- Bachelor's degree in science, health profession, or journalism
- It is important that this person have experience with Regulatory submissions, Investigator Brochures, and Clinical Study Reports.
Contact:
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| Medical Writer
Cincinnati, OH |
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Our client located in the Cincinnati, Ohio is in need of an experienced Medical Writer to work out of their Cincinnati facility and complement their existing staff. Our client, a CRO, has retained Sanford Rose Associates-Prospect to assist with the interviewing and identification of the ideal candidate. If you feel you are a qualified candidate, have interest and feel this position may be right for you please forward your resume or CV to the following address for consideration:
jessicac@sanfordrose.com
Job Duties:
- Write clinical study reports, integrated summaries of efficacy and safety, and protocols
- Coordinate quality assurance reviews of documents and maintain audit trails of changes
- Provide input on data analysis planning and interpretation
Qualifications:
- Bachelor's degree in a health or science field
- 1-5 years of prior experience as a medical writer
- Advanced knowledge of medical terminology and word processing
- Must have experience with INDs and NDAs
- Strong communication skills (both written and oral)
Travel: None anticipated | |
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DISCLAIMER: Biotech Ink, LLC, and the Biotech Ink Insider provide the Insider jobs list on an "as-submitted basis," and neither assumes responsibility for, nor guarantees the quality or accuracy of, any listing or response. All listings are provided as a free service and courtesy to subscribers and users. Subscribers and users assume all risk in using the information in the Insider.
Have comments or questions about the Insider? Please send your feedback to Susan E Caldwell at caldwell@biotechink.com, or phone 650-286-9300. Unless stated otherwise, all Biotech Ink Insider content Copyright 2009. Biotech Ink, LLC. All rights reserved. |
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