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This position will primarily focusing on, but not limited to, the following:
- Plans, monitors and works closely with Contract Research Organizations (CROs) to conclude bioequivalence studies in order to obtain FDA approval of the Company’s products. Involves reviewing clinical study protocols and bioanalytical validation reports, and conducting pre-study site audits of CRO responsible for the completion of the study.
- Conducts CRO site visits in preparation of FDA audits. Ensures that bioequivalence data and test materials located in study site are found satisfactory and are qualified for approval by FDA. Records information and reports findings relating to the site visits.
- Ensures that the studies are completed according to good clinical practices and that all data is accurate.
- Monitors dosing and conduct of bioequivalence studies and files study monitoring reports.
- Assists in the review, approval and coordination of providing clinical supplies designated for multiple sites as well as shipment of necessary documents.
- Participates in company wide SOP training program, as well as R&D administrative matters pertaining to internal policies of R&D department, the company and archiving of study documents.
- Complies with all Company policies and procedures, including safety rules and regulations.
- Performs related duties as assigned.
Related project/program management experience is required. Knowledge of pharmaceutical principles, practices, and application. Knowledge of pharmacokinetics, bioanalysis, biostatistics and in vitro dissolution is required. Knowledge of global regulatory agency requirements and generic industry experience are highly preferred. Respiratory drug product experience desirable, but not required.
Bachelors degree in a scientific/technical or related field from an accredited college or university, and six (6) years pharmaceutical/clinical experience.
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