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 Purpose: The CPMS Asia/Japan Manager will provide technical therapeutic, and product development support for GlaxoSmithKline projects. Individuals will ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practice
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 · Check