22 January 2010                 Published weekly by Biotech Ink, LLC Vol 3 No 2

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Education on the Fly with Podcasts
by Mitch Gordon
 
Angel Bivins photoDoesn't it seem that there's so much to learn, and so little time? I certainly feel that way. The biomedical industry is complex and multidisciplinary. Success in your particular field often requires a solid understanding of multiple unrelated subjects. How do you acquire the knowledge you need when you have limited time because of your job, family life, and other responsibilities?
One helpful strategy I've adopted is to listen to podcasts while I'm driving. A podcast is a recording, typically in MP3 format, that you download from the internet. Podcasts can be downloadable audio or video files, but I find the audio files more useful.
There are at least 3 ways to listen to podcasts that come to mind:
(1)  You can burn podcast files on a CD-ROM and play them on the CD player in your car, if it plays MP3 CDs (data CD-ROMs that have MP3 files burned on them); if your car's CD player doesn't play MP3 CDs, you could replace it with one that does.
(2)  You can play podcasts with your MP3 player (eg, iPod).
(3)  You can play podcasts on your computer using iTunes or another player.
There are thousands of good podcast lectures available at little or no cost on a wide range of useful subjects. You can also buy more expensive lectures, if you need the material badly enough to justify the expense.
If you want to save money, search the web for free podcasts before buying them. Here are three great podcast sources that have been very useful for my self-education on the go:
This podcast site at the University of California at San Diego is amazing. UCSD's policy is to record and podcast all of the lectures in a growing number of undergraduate classes, especially in the biology department. The biology courses for the current quarter include one lower-division class and 15 upper-division: Nutrition, Genetics, Cell Biology, Endocrinology, Biostatistics, and Mammalian Physiology I and II, to name a few. The chemistry department podcasts their inorganic and organic chemistry sequences, and the psychology department offers some good neurobiology courses.  A typical podcasted UCSD course consists of 20 to 30 lectures, each lasting roughly one hour.
If you don't have a strong life sciences background, or you need a good review, the UCSD course podcasts are a terrific way to build up your scientific knowledge. You become a virtual medical biology undergraduate at a reputable university, and it costs nothing but your time. The instructors are excellent, and it's a pleasure to listen to them. Of course, you don't get to see what gets written on the whiteboard or shown on slides. But you can compensate for the missing visuals with a good used textbook. Also, note that the UCSD podcasts are typically removed just after the end of the quarter when the course was offered, so you need to download them before the end of the course. All in all, you can't beat the UCSD podcast site for giving you a basic medical biology background without going back to school. I've listened my way through about 10 of these courses, and I still have plenty to go. Thank you, University of California!
Another podcast site I recommend is Grammar Girl's Quick and Dirty Tips for Better Writing, at http://grammar.quickanddirtytips.com/. As professional writers, many of us still have less-than-perfect grammar and punctuation knowledge. Grammar Girl, aka Mignon Fogarty, has recorded over 100 short (5- to 10-minute), entertaining talks on correct word use, punctuation, and sentence structure. Of course, you won't get as complete a grammar education here as you might from studying the Chicago Manual of Style, but you'll have more fun learning, and it's free! To get to the complete list of Grammar Girl podcasts on the site, click the "Listen or Read" button, then select either "iTunes" or "Podcast RSS" under the "Subscribe" heading. Note that Mignon Fogarty also has Grammar Girl audiobooks and grammar tip books in print.
Using this great podcast site requires your membership in the Association of Clinical Research Professionals (ACRP). If you plan to do any medical writing related to clinical trials, whether protocols, investigator brochures, or study reports, you really should belong to ACRP. We have an especially active ACRP chapter in Northern California; I find their meetings very informative, and the members are a real pleasure to know.
The podcasts I have in mind are located on the ACRP website, at www.acrpnet.org. ACRP has podcasted the entire proceedings of the 2009 ACRP conference, and sells the entire set to members (including PDF files of the slideshows) for $49. There are about 150 talks, on subjects such as how to manage clinical study sites; recruit and retain subjects; conduct clinical trials in India, Argentina, and Australia; understand HIPAA; and implement electronic data capture. There are also two or three panel discussions with FDA representatives. If you want to learn what clinical trials are all about from the perspective of the people who make them happen, this is an extremely worthwhile set of lectures. And if you drive as much as I do, it won't take long to finish all 150 podcasts!
There you have my three favorite podcast sites. Search the internet to find your own preferred sources of podcasts that meet your continuing education needs. If you spend much time commuting, you'll find listening to educational podcasts to be a really valuable use of your time.
 
About the Author
 
Mitch Gordon has been a professional writer for 16 years. He is completing his Masters degree in Regulatory Affairs, to be finished in early 2010. His specialties are regulatory and clinical documentation, as well as a wide range of other writing and editing roles that support life sciences companies. 
 
Mitch Gordon
Medical and Regulatory Writing
Website: http://www.mitchgordonwriter.com
Tel: 707-869-4561
Identifying and Selecting Key Opinion Leaders
Part 2: Characteristics, Criteria, and the Selection Process
by William Yarnall, RPh, CCP
 
BYarnall

By definition, key opinion leaders' (KOLs') thoughts are valued. The KOL's ability to influence is sought after for participation in professional activities, such as symposia and other speaking engagements, authorships, and clinical trials.

 

Start the KOL selection process by researching the disease state of interest, and identify key professional organizations. Examples include the American Diabetes Association or American College of Rheumatology, or other groups in which you'd expect prospective KOLs to participate. Identify the names that repeatedly appear in connection with professional activities, and verify their authorial status using Medline. Then, you are ready to initiate contact with potential KOLs and further investigate their background. Request a current CV through the potential KOL's place of business or academic affiliation. 

 

Current Standing in Professional and Academic Communities

 

When perusing the potential KOL's CV, look for their appointed titles, such as Chief of Staff, President, or Medical Director. There are other clues that can indicate that the candidate has either been elected or appointed to their current position(s). These include being the head of an administrative arm or medical specialist's organization within a sizable hospital system, medical facility, or teaching hospital. Beware of titles such as President or Director, when attached to private or small group practices or to small clinical research organizations. Typically, such titles are self appointed and originate when an individual starts a business.

 

You should also investigate the facility itself to determine its significance. Many nursing homes and day-care facilities use comparable titles to identify staff, but these facilities are common and association with them doesn't indicate KOL stature. Academic titles, such as Clinical Associate Professor of Medicine, clearly do indicate a level of professional and academic engagement that characterizes KOL activities. Related affiliations to be aware of include those with medical institutions of renown, such as Harvard Medical School, the Mayo Clinic, Yale, and the Cleveland Clinic; these affiliations are not easy to acquire, and they suggest that the prospective KOL is someone of influence.

 

Current Publication Credentials

 

Barring exceptional circumstances, the prospective KOL should claim authorship in relevant top-tiered journals within the last 3 to 5 years. Exceptional circumstances might include "legend" status, such as being a former Director of the Framingham Heart Study.

 

While not necessarily required, publication within top-tier medical journals contributes significantly to the potential KOL's reputation. Examples of these journals include the New England Journal of Medicine, JAMA, and The Lancet. Within each medical specialty, peer-reviewed journals are also recognized by tier, and you should be familiar with this hierarchy in the specialty of interest.

 

Professional Leadership Roles

 

Your KOLs should demonstrate leadership in their specialties. Professional fellowship, such as a Fellow of the American College of Physicians (FACP), is an earned credential of elevated status within a professional organization, often included with the physician's name, degrees, and title.

  

Holding an elected office in a major scientific or professional organization, such as presidency of the American College of Rheumatology, is also an indication of significant achievement. Elected offices should be currently active roles or titles held no more than 5 years ago. 

 

Participation in Medical Society Presentations and Funded Clinical Trial Research

 

In reviewing the credentials and activities of potential KOLs, you should distinguish between their major medical society presentations, which are important, and presentations that are not important, because both kinds appear on CVs.  Presenting on a major clinical or scientific topic at the American Diabetes Association Annual Meeting is a significant achievement. However, grand-rounds presentations at the hospital where the clinician works are not distinguishing, because they're probably part of the job. Presentation experience should have been roughly within the last 2 years.

 

Look for titles, such as Principal Investigator for phase 3, multicentered, randomized, double-blind, placebo-controlled clinical trials within a discipline related to your area of interest. This is a key role through which a potential KOL may authoritatively address key issues. Other significant titles include Principal Investigator or Sub-investigator; activities within these roles should have occurred within the last 5 years. Lesser, but noteworthy, KOL credentials might include teaching or lecturing awards, relevant regulatory and other government experience, or speaking before Senate subcommittees. 

     

Conclusions

 

Selecting KOLs is a multifaceted screening process. The weight and content of evaluative criteria may vary, depending on the goals of your specific program. KOL selection and validation isn't an exact science; in the end, common sense should prevail.

 

 

About the Author

 

Bill Yarnall is a dual-degreed writer-turned-pharmacist-turned-medical-writer. He has more than 16 years experience designing and writing accredited and non-accredited medical education programs. Bill works in any and all therapeutic areas and specializes in text-based electronic or print medical education media.

 
William Yarnall, RPh, CCP

President

DoctorLearns LLC

PO Box 1504

Merchantville, NJ 08109

Email: [email protected]

Tel: 856-662-3618

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.
 
Because of the tough job market in recent months, we are now publishing jobs that are closely related to medical writing, or that have a strong writing role, regardless of their titles.
 
If you're a writer or editor and are getting calls about staff or contract positions you aren't interested in, please forward the job information to Susan Caldwell at [email protected]. We'd be delighted to publish such positions in the next issue of the Insider.
Medical Writer
Winston-Salem, NC
 
Excellent opportunity for a permanent medical writer in Winston-Salem, North Carolina. Medical Writer is expected to deliver high quality regulatory documents that meet ICH standards, project timelines, and regulatory specifications. The responsibility of the Medical Writer includes the management and preparation of a variety of clinical documents including protocols, clinical study reports, narratives, worldwide regulatory submissions, and investigator brochures for clinical trials. Relocation is an option for the right candidate.
 
Responsibilities:
  • Work with key interface partners (eg, Project Management, Statistics, Programming, Chemical Manufacturing, Regulatory Affairs) to facilitate completion of complex documents, including protocols, clinical study reports, investigator brochures, and other clinical and regulatory documents.
  • Participate ad-hoc on relevant project teams and task forces, and provide guidance to clinical, safety, nonclinical, Quality, and CMC functions on a wide range of issues related to document preparation and production. These include US and international regulatory guidance and requirements for content and format, organizational requirements (style, electronic integrity, and process), and project- or therapeutic-area-specific guidance related to content and organization of specific documents.
  • Use project management skills to create timelines, track, review, and ensure timely completion of high quality regulatory and clinical documents.
  • Participate in planning of analysis and data presentation to be used in study reports or summary documents.
  • Review data to determine the appropriate tabular and textual formats, and the clarity, logic, and order of presentation.
  • Develop and update specifications, formats production elements, and tracks regulatory documents and artwork used in regulatory documents.
  • Develop and update editorial style standards, provides guidance to project teams regarding regulatory submissions, and develops and updates general writing guidelines.
  • Document, review, update, and maintain Standard Operating Procedures (SOPs) for all medical writing activities in accordance to good Clinical Practices and Federal Regulatory requirements.
  • Participate, as needed, in the creation of SOP templates for all functional areas and with QA staff.
  • Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other internal departments, as necessary.
  • Other duties, as assigned.
Qualifications:  
  • BS + 5 years experience with pharmaceutical industry scientific/medical/regulatory writing/editing, and manuscript preparation for technical documentation
  • Scientific or medical background, as applicable
  • Working knowledge of applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and assure compliance with SOPs
  • Extensive experience with writing phases 1 through 3 CSRs, INDs, NDAs, narratives, investigator brochures, ISE/ISS, and other clinical documentation.
  • Experience in data handling and analysis
  • Good written and verbal communication skills
  • Ability to write fluent and grammatically correct English
  • Good word processing skills and good at working with templates
  • Good organizational and time management skills
  • Pays attention to detail
  • Able to work to tight timelines while maintaining accuracy
  • Team player
  • Familiarity with Quality Assurance and Quality Control procedures
  • Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions-Proficient with Word and electronic templates
  • Able to work proactively with minimal supervision
  • Able to manage several studies and enjoy analyzing the cause of problems, finding the right approach and directing the implementation of solutions
  • Must be able to work 100% in-house. No telecommute. No work from home. 
Contact:
Email your resume to MedFocus, LLC, at [email protected].
Senior Medical Writer
Montville, NJ
 
A Major Pharmaceutical Company is looking for a Sr. Scientific Medical Writer in Montville, New Jersey!
The Senior Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
  • Participating in the development of the strategy of the submission and the label and the carrying through of those key messages into other regulatory documents
  • Assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
Requirements:
  • Bachelor's degree or equivalent, with a minimum of 6 years in Medical Writing.
  • Master's degree, PhD, or equivalent with a minimum of 5 years previous industry experience and three years of medical writing experience.
  • Demonstrated working knowledge of scientific principles.
  • Excellent written and oral communication skills in English.
  • Familiarity with all phases of medical research and ability to learn new medical concepts quickly.
  • Familiarity with statistics and experimental design. 
  • Ability to summarize complex data and identify relationships. 
Contact:
 
Email your resume to MedFocus, LLC, at
[email protected].
Medical Writer
Montville, NJ
 
A Major Pharmaceutical Company is looking for a Scientific Medical Writer in Montville, New Jersey!
The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
Assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
 
Requirements: 
  • Bachelor's degree or equivalent, with At least 6 years experience in a scientific discipline and a minimum of 4 years in Medical Writing.
  • Master's degree, PhD, or equivalent with a minimum of 2 years previous industry experience.
  • Demonstrated working knowledge of scientific principles.
  • Excellent written and oral communication skills in English.
  • Familiarity with all phases of medical research and ability to quickly learn new medical concepts.
  • Familiarity with statistics and experimental design.
Contact:
 
Email your resume to MedFocus, LLC, at [email protected].
Medical Writing Specialist
Montville, NJ
 
The Medical Writing Specialist is responsible for the tracking, quality control and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents.
Responsibilities:
  • Working together with key interface partners (eg, Study Management, Statistics and Programming) to facilitate the completion of clinical study reports and their appendices. Using project management skills to track, review, and ensure timely completion of high quality regulatory documents.
  • Checking that study file components (eg, Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements.
  • Acting as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guides to reflect new agreements and changes due to SOPs and regulatory guidelines.
  • Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent.
  • Performing real-time edits to clinical documents during comment review and resolution meetings.
  • Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation, and electronic publishing.
  • Managing the review and approval of documents in the document management system using standard procedures.
Requirements:
  • Bachelor's or Associate's degree with strong electronic documentation and word-processing skills
  • Excellence in written and oral communication skills in English
  • Excellent interpersonal skills
  • Familiarity with clinical research, statistics, and regulatory submission requirements preferred
  • Must be able to work 100% in-house. No telecommute. No work from home. 
Contact:
Email your resume to MedFocus, LLC, at [email protected].
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