RE: Biomed - Wave of the Future - Evolve?

["Goldstein, Dan" <DGoldstein -at- DeusTech -dot- com>]

I agree with Diane's disagreement (?). I am working in the medical device
field, also with FDA documentation requirements under Title 21 of the CFR,
and a scientific background is *not* required. Maybe it would tip the scales
between two writers who are equally qualified in all other ways, but that's
another matter.

Dan Goldstein

-----Original Message-----
From: Diane Evans [mailto:diane_evans -at- hotmail -dot- com]
Sent: Tuesday, September 09, 2003 10:41 AM
To: TECHWR-L
Subject: Re: Biomed - Wave of the Future - Evolve?

>"Biomed" breaks down into two general areas, pharma (drugs) and device.
>It's quite difficult to transition into pharma if you don't have a 
>technical
>background in medicine or biology.

Now, here is where I disagree.  I am working in a biotech arena, a gene 
expressions laboratory. 
(http://www.genome.gov/glossary.cfm?key=gene%20expression).  I know nothing 
about drugs, medicine, or biology.  I simply document software being built 
for use inside our laboratory walls.  I haven't written a help manual yet 
(our policy is -- if the scientists have questions, they can come down the 
hall and see us).

This may be the wave of the future in biotech; as more sophisticated 
computer systems are required for drug discovery, software developers are 
needed to build the software, and technical writers are needed to ensure 
that the documentation required by the FDA under 21 CFR Part 11 
(http://www.21cfrpart11.com/) is complete.

Diane Evans
Technical Writer
Washington State Coordinator, Tombstone Project