Susan Bairnsfather, Medical Writer

Current

CEO, Pharmaceutical Consultant at EPharmaTech, LLC

Past

Medical Writer, Project Manager at Image Solutions
Sr Statistical Programmer at PharmaNet
Clinical Consultant at NovaTech Sciences

Sr Regulatory Associate at Boots Pharmaceuticals

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1 more...

Education

.Louisiana State University School of Medicine
.Northeast Louisiana State University
`Louisiana State University

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Recommended

2 people have recommended Susan

Connections

48 connections

Industry

Pharmaceuticals

Susan Bairnsfather, Medical Writer’s Summary

Professional Services:
- Contract regulatory writer ( Contract medical writer )
- Regulatory submissions publisher
- Statistical analyst.

EPharmaTech, LLC offers contract services supported by 20 years of pharmaceutical and biotech industry experience and global submissions to FDA and EMEA.

With esubmissions now required for regulatory authorities, multiple personnel are hired for the functional roles of medical writer, regulatory associate, and submissions publisher. The most knowledgeable staff to drive the writing of documents and the completion of submissions are individuals cross-trained in both scientific research and computing areas of expertise. EPharmaTech offers those cross-trained personnel ... those who can provide sound science and data interpretation, regulatory writing electronically integrated into the eCTD, and regulatory publishing of documents. This encompassing knowledge expedites the filing of esubmissions. ___________________________________________________________________

Professional Training Services:
The following topics have been presented as training workshops at Drug Information Association, American Medical Writers Association, European Medical Writers Association, Pharmaceutical SAS Users Group, and other organizations: biostatistics, drug development, clinical study reports, pharmaceutical industry standards, computer validation, structured product labeling, content template creation, and SAS presentation concepts related to medical writing.
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Document Experience:
Integrated summary of efficacy, integrated summary of safety, investigator brochure, package insert, summary of product characteristics, clinical study report, nonclinical summary, electronic common technical document, protocol, patient narrative, statistical analysis plan, and 510k for devices.
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Susan Bairnsfather, Medical Writer’s Specialties:

Therapeutic areas of expertise include: analgesia; anti-infectives; cardiology 1; CNS (psychotherapeutic agents) 1,2; dermatology; endocrinology 2; gastroenterology; gynecology; hematology; immunology; obesity; oncology; ophthalmology; pulmonology; rheumatology; and urology.
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1 Writing, personal compilation, and submission of NDA
2 Writing, personal compilation, and submission of IND

Susan Bairnsfather, Medical Writer’s Experience

CEO, Pharmaceutical Consultant

EPharmaTech, LLC

(Pharmaceuticals industry)

2006 — Present (3 years )

Consultant to the pharmaceutical industry performing each of the following pharmaceutical industry functions for global esubmissions:
- contract medical writing
- contract regulatory affairs professional
- contract regulatory submissions publishing
- contract statistical analyses

Affiliations:
- American Medical Writers Association
- European Medical Writers Association
- Regulatory Affairs Professionals
- Drug Information Association
- HL7 Technical Team for SPL
- CDISC Contributor
- Information Technology Professionals
- Pharmaceutical SAS Users Group
- Alpha Epsilon Delta Honors
Medical Writer, Project Manager

Image Solutions

(Pharmaceuticals industry)

January 2005 — October 2006 (1 year 10 months)
Sr Statistical Programmer

PharmaNet

(Pharmaceuticals industry)

2000 — 2004 (4 years )
Clinical Consultant

NovaTech Sciences

(Pharmaceuticals industry)

1996 — 2000 (4 years )
Sr Regulatory Associate

Boots Pharmaceuticals

(Public Company; 1001-5000 employees; Pharmaceuticals industry)

1988 — 1996 (8 years )

Susan Bairnsfather, Medical Writer’s Education

.Louisiana State University School of Medicine

Masters level + 20 hours , Pharmacology
.Northeast Louisiana State University

BSc , Pre-Medicine; Biochemistry major & Human Biology major
`Louisiana State University

BSc , Computer Science

Additional Information

Susan Bairnsfather, Medical Writer’s Groups:

See American Medical Writers Association (AMWA) international organization at
http://www.amwa.org

See European Medical Writers Association (EMWA) international organization at
http://www.emwa.org

See Regulatory Affairs Professionals (RAPS) international organization at
http://www.raps.org

See Drug Information Association (DIA) international organization at
http://www.diahome.org

See Pharmaceutical SAS Users Groups (PSUG) international organization at
http://www.sas.com

See Clinical Data Interchange Standards Consortium (CDISC) international organization at
http://www.cdisc.org

See The Content Wrangler (TCW) national organization at
http://www.thecontentwrangler.com