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Actually, the FDA material I was referring to were NDAs,
BLAs, IBDs, etc. I hadn't even begun to address all the
support systems that lead up to those. I was trying to
make the point that there's loads of writing work in
biotech/med that doesn't require a medical or biology
background, and that a lot of it really isn't all that
different from the technical writing that goes on in non
biotech companies. BTW, are you doing your writing as
part of the same group that documents product, or are
you under the Facilities/IT/IS umbrella at your company?
Gene Kim-Eng
------- Original Message -------
On
Tue, 9 Sep 2003 15:08:40 -0400 Goldstein, Dan?wrote:
No, but it isn't the user-level docs that you referred to that I got hired
to write (though I do them, too). It's the FDA work which you referred to as
being prepared by a "regulatory affairs groups separate from the tech pubs
groups." Much of the documentation required by the FDA is internal
documentation that's audited to ensure adherence to quality guidelines --
which is a big part of both pharma/drug and device work.
