EDUCATION:
| M.S. |
|
Johns
Hopkins University, Biotechnology & Regulatory Affairs
(2007) |
| B.S. |
|
James
Madison University, Harrisonburg, VA; Biotechnology, Marketing
(2001) |
|
|
|
EXPERIENCE:
CURRENT
POSITION:
2001 to present |
|
Associate,
Biologics Consulting Group Inc.
Alexandria, VA.
- Assist
in the preparation of Investigational New Drug Applications
(INDs), Biologics License Applications (BLAs), amendments
and supplements, CTDs, Establishment & Product
Listings for foreign manufacturers, and Annual Report
submissions to the Food and Drug Administration's
(FDA) Center for Biologics Evaluation and Research
(CBER).
- Coordinate
the company's marketing activities (conferences, direct
mailings, new consultant announcements, etc.)
- Designed
and maintain MS Access database to track FDA submissions
and client correspondence
- Designed
and maintain MS Access client database
- Designed
and coordinate monthly e-newsletter mailings
- Work
closely with graphic designer and printers to design
trade show displays, brochures and promotional products
- Serve
as the company's benefits administrator
|
| |
|
|
| Spring
2001 |
|
Marketing
Assistant, Fisher Diagnostics, Middletown, VA.
- Responsible
for lead generation for contract manufacturing of
diagnostics
- Maintained
database of current clients and potential leads
- Conducted
internet research to establish potential leads
|
| |
|
|
| Summer
2000 |
|
Laboratory
Technician, Sun BioMedical, Blackwood, NJ.
- Researched
immunochromatographic techniques for drug screening
urine tests.
- Prepared
reagents according to SOPs
- Evaluated
and optimized the test components for rapid diagnostic
tests
- Reported
and recorded the test results, keeping the records
according to FDA's GLP requirements
- Performed
in-house drug testing on walk-in patients
|
CONTINUING
EDUCATION:
| Sept.
2007 |
|
RAPS
2007 Annual Conference & Exhibition |
| Oct.
2006 |
|
RAPS
2006 Annual Conference & Exhibition |
| Oct.
2005 |
|
FDA's
eCTD Tutorial |
| Oct.
2005 |
|
RAPS
2005 Annual Conference & Exhibition |
| June
2005 |
|
BIO
2005 |
| Oct
2004 |
|
RAPS
2004 Annual Conference & Exhibition |
| Sept
2004 |
|
PDA/FDA
Joint Regulatory Conference |
| Oct
2003 |
|
RAPS
2003 Annual Conference & Exhibition |
| Oct
2003 |
|
Virginia
Biotechnology Summit and Governor's Conference |
| June
2003 |
|
BIO
2003 |
| Oct
2002 |
|
RAPS
2002 Annual Conference & Exhibition |
| Oct
2002 |
|
Virginia
Biotechnology Summit and Governor's Conference on
Technology Transfer and University Research |
| Apr
2002 |
|
RAPS,
RA/QA 101 |
| Oct
2001 |
|
Virginia
Biotechnology Summit and Governor's Conference on
the Human Genome and the Law |
| Nov
2001 |
|
RAPS
Annual Conference & Exhibition |
PROFESSIONAL
SOCIETIES
- Regulatory
Affairs Professional Society (RAPS) - member 2001
to present
|
| |
|
Page
Updated:
June 16, 2008
|
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|
