2008-09 Chapter Officers' Bios

Susan Bairnsfather
Director-at-Large

Professional title & affiliation

CEO
ePharmaTech, LLC
Shreveport, LA
USA

Professional background

Susan began her medical writing career in 1988 in the regulatory department of Boots Pharmaceutical, Inc. In 1995, the company sold to Knoll Pharmaceuticals in New Jersey. Rather than move from Louisiana to New Jersey, Susan created a home office and has worked from the home office since 1995. During the first few years of working from home, opportunities to work from home as a full-time employee were offered only from CROs who needed statistical programmers. Therefore, Susan worked as a statistical programmer with CROs for the first several years. In 2004, Susan decided to return to a regulatory writing career and to look for a regulatory writing position. She became a member of AMWA and attended the October 2004 national meeting. In 2005, she returned to working again as a medical writer. In 2006, she created ePharmaTech, LLC and began providing contract services to the pharmaceutical industry for regulatory writing, regulatory submissions publishing, and statistical analysis. ePharmaTech currently offers services from Susan’s expertise as a cross-trained individual in the these pharmaceutical functional roles, as well as expertise from other talented individuals. This cross-training facilitates a faster delivery of written regulatory documents that clearly convey the science and expedites the electronic submission-ready format. See epharmatechllc.com for more information.

Other professional affiliations/offices held

• AMWA (2004)
• EMWA (2008)
• RAPS (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 & certifications

• 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

Quote

People often forget that your expertise produced the job fast. After their deadline has passed, the excellent job will be remembered.