Kate Urquhart

EDUCATION
1977 B.A., Education, University of North Carolina, Chapel Hill, North Carolina
WORK EXPERIENCE
August 2002 ? King Pharmaceuticals Research & Development, Cary, NC
present Senior Report/Document Specialist
Create and maintain templates (ICH standard) for protocols, clinical study repo
rts, annual reports, and other documents for submission to the U.S. Food and Dru
g Administration (FDA). Edit and provide quality assurance as necessary.
Finalize clinical protocols, clinical study reports (including all appendices,
listings, etc. according to ICH guidelines), annual reports, FDA briefing docume
nts, and other documents before publishing and submission to the FDA.
Coordinate with Regulatory Affairs personnel to publish NDAs, INDs, Annual Repo
rts, CSRs, and other documents. Work with vendors and King medical writers to c
ompile source documents (clinical and non-clinical study reports, protocols, pub
lications, etc.) for publishing and submission to the FDA.
Create, maintain, and update electronic directories of all clinical reports and
pertinent documents.
Coordinate with contractors on templates for CSRs, protocols, and other documen
ts.
Troubleshoot Microsoft Word and Adobe problems for King employees and offer sug
gestions for creation and format of documents.
May 1996 - Quintiles, Research Triangle Park, NC
August 2002 Associate Document Management Specialist
Create client deliverable documents and submissions using the standard word pro
cessing or publishing/document management systems
Proofread/review/edit documents processed for accuracy and completeness
Troubleshoot technical problems within documents and offer assistance to cowork
ers with technical problems.
Coordinate complex and large volume projects with minimal supervision or direct
ion.
Prepare, format, and print documents [protocols, analysis plans, table shells,
study reports, IND sections, NDA sections, in-text panels, and summary tables]
for submission to clients or the FDA. Responsible for assuring that documents a
re formatted according to corporate or client standards.
Utilize advanced features of Microsoft Word 97 such as creation of text boxes,
columns, outline numbering, footnotes, etc. as required for needs of project. U
tilize other software packages such as Visio and Power Point as needed for proje
cts.
Serve as a project team member in cases where specialized tasks are required, d
evelop and document the procedure (if necessary) and complete tasks in accordanc
e with clients? and other departments? needs. Examples of such tasks include: a
dvanced equations, linking figures and tables, inserting figures and graphs from
other software packages, creating drawings and charts, and converting between s
oftware packages.
June 1980 - Entropy, Inc., Raleigh, NC
May 1996 Manager, Document Production
Responsible for all final reports issued to clients. Entropy is an air polluti
on measurement and consulting company and clients range from the U.S. EPA to pri
vate industry.
August 1979 - Bertie County Schools, Windsor, NC
June 1980 Primary Education Teacher, West Bertie Elementary School, Lewiston, NC
References are available upon request.