Basic purpose of the job Independently writes and manages clinical documents, such as clinical trial reports, Investigation Brochures, Protocols and briefing documents, in both local and global cross-functional project- and study teams, as well as local
Job Description · Contribute to regulatory events in Japan such as CTN, PMDA consultation and JNDA · Contribute to Drug Metabolism and Pharmacokinetics (DMPK) and CP sections in the regulatory documents such as JCTD and JIB ·
1. Objectives: In order to obtain high-quality pharmacokinetic (PK)/biomarker/antibody/pharmacogenomics (PGx) data from a clinical study, take charge of series of work concerning PK/biomarker/ antibody/PGx assay and oversight assay sites in order to execute these duties. In addition
