Susan Bairnsfather entered the pharmaceutical industry
over 20 years ago with science degrees in pre-medicine
(human biology major and biochemistry major) and
computer science, and additionally postgraduate studies
in pharmacology at Louisiana State University Medical
Center. She worked for 7 years as a regulatory associate,
10 years as a statistical programmer, and 2 years as a
regulatory writer before establishing her own company,
EPharmaTech, in 2006. She now provides consultant
services as a regulatory writer, regulatory publisher,
and statistical programmer. Susan has wide experience
in writing the full range of preclinical and clinical
regulatory documents, including submissions for the US,
Canadian, and EU authorities. She is also experienced in
data analyses and in electronically integrating documen-
tation to the eCTD. She has been active as a member,
presenter, and work shop leader for American Medical
Writers Association (AMWA), European Medical Writers
Association (EMWA), Drug Information Association (DIA),
and the Pharmaceutical SAS Users Group (PSUG). She
has additionally participated in CDISC and in HL7 SPL
initiatives.
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