Susan Bairnsfather
Director-at-Large

Susan BairnsfatherProfessional title & affiliation

CEO, Medical Writer/Regulatory Writer
ePharmaTech, LLC
Shreveport, LA

Professional background

Susan entered the pharmaceutical industry over 20 years ago with degrees in pre-medicine (human biology and biochemistry majors) and computer science and a postgraduate qualification in pharmacology from 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 consultancy services as a regulatory writer, regulatory publisher, and statistical programmer. She has wide experience in writing the full range of preclinical and clinical regulatory submission documents, including submission dossiers for the United States, Canadian, and European Union authorities. She is also experienced in data analyses and in the preparation of parts of eCTDs and the creation of structured product labeling (SPL). She has been active as a member, presenter, and workshop leader for AMWA, EMWA, the Drug Information Association (DIA), and the Pharmaceutical SAS User Group (PharmaSUG).

Other professional affiliations/offices held

  • AMWA (2004)
  • EMWA (2008)
  • Regulatory Affairs Professionals Society (1989)
  • DIA (2005)
  • PharmaSUG (1989)
  • HL7 Tech Team for Structured Product Labeling (SPL, 2006)
  • Contributor to CDISC Clinical Data Acquisition Standards Harmonization (CDASH, 2008)

Education

  • Masters level + 20 hours, Pharmacology, Louisiana State University Medical School
  • BSc, double major in Biology and Chemistry, University of Louisiana at Monroe
  • BSc, Computer Science, Louisiana State University

Training/courses/certifications

  • Certification in AMWA Advanced Curriculum, 2008
  • Certification in AMWA Core Curriculum - Pharmaceutical, 2008
  • Certification in AMWA Professional Development, 2007
  • Essentials of Japanese Regulatory Affairs, 2007
  • eCTDManager Software Training for Pharmaceutical Product Applications, 2007
  • European Union Central and Mutual Recognition Submissions, 2006
  • Canadian Regulatory Affairs, 2006 SAS Output Delivery for Statisticians, 2004
  • XML Data Exchange Between SAS and Other Platforms, 2003

Presentations/publications

  • Statistics for Medical Writers, 2007 AMWA annual national conference, Atlanta, GA
  • Statistics for Medical Writers, 2006 AMWA annual national conference, Albuquerque, NM
  • SAS Concepts for Medical Writers, 2006 AMWA annual national conference, Albuquerque, NM
  • Statistics for Medical Writers, 2005 AMWA annual national conference, Pittsburgh, PA
  • SAS Concepts for Medical Writers, 2005 AMWA annual national conference, Pittsburgh, PA
  • Evolving Standardization of Clinical Data: Drug Submissions Integrated with Healthcare Initiatives, 2005 DIA, Washington, DC
  • Proc Telecommute, 2005 PharmaSUG annual national conference, Phoenix, AZ
  • Progress Toward Standardization of Submissions with the Electronic Common Technical Document and the Evolving Standardization of Clinical Data, 2003 PharmaSUG annual national conference, Miami, FL