To produce and supervise the production of GLP/GMP documents for the BTC Toxicology,
Pharmacokinetics, and Discovery/Safety Pharmacology laboratories.
Interface with BTC Study Directors and outside sponsors regarding document production, data
presentation, and project management.
Provide for supervision of report writing/project management staff within the BTC.
Provide project management to track progress of ongoing studies.
Organize data, coordinate statistical analysis, & present data in tabular or graphical form
for inclusion in final reports.
Write and edit study protocols and reports to meet FDA GLP.GMP regulatory guidelines.
Produce custom study books and data collection forms to meet the needs of the Study Director
Route documents for review, revision, and approval by Study Director, study personnel, and
BS or BA in science with 205 years of Windows-based word-processing programs and spreadsheet
Strong organizational skills, with proven ability to organize/prioritize projects to meet the
objectives of the company and customer.
Excellent interpersonal and written and verbal communication skills with staff, management,
subcontractors, and customers.
Understanding of basic toxicology, pharmacokinetic studies; familiar with animal models used
in pharmaceutical research; knowledge of FDA and EPA GLP regulations.