Monitor and support conduct of PK data analysis using software, such as WinNonlin and/or NONMEM Play an active role on cross-functional project teams as a PK office representative Review and provide contributions to the Statistical Analysis Plans and or write separate PK Analysis Plans Contribute to the clinical pharmacology sections of relevant documents, such as clinical study protocols, clinical study reports, investigator's brochures, briefing documents, and regulatory submissions Work closely with regulatory affairs personnel, if required, to provide PK data in support of regulatory communications and presentations as needed People/project management along with ensuring day to day operations Ensure the optimal quality of deliverables by assigning layers of peer/internal QC before sharing the output with sponsor/client
Ensure allocation of qualified and well trained resources to the study Experience and Skills Required: Minimum 3 Years in PK Analysis contribute to the clinical pharmacology sections
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