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(Sr.) Medical Manager
Location:
Beijing
Description:
General job accountability: • Lead the clinical trials for the assigned compounds or products in China and/or globally (for some specific China R&D-driven compounds). • Accountable for all clinical trials deliverables according to Clinical Development plan. Principal accountability and internal and external contacts: (Please attach other paper if needed) A. Primary responsibility • Deeply understand global clinical development strategy and plan. Lead cross-functional team to development and drive CD strategy and plan and ensure the clinical development plan fully aligned with China and globally (for some specific China R&D driven compounds). Keep the China clinical development plan updated. • Propose clinical study design and develop clinical study protocol based on the clinical development plan. Be accountable for all clinical deliverables (e.g. clinical study reports and submission summary / HA response document, contribute to HA interactions, such as CDE panel meeting and responsible for the clinical questions, etc.) if applicable. Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. Provide physician guidance and expertise on patient care to clinical studies (including medical monitor, etc.) if necessary. • Lead the clinical trials for the assigned compounds or products in China. • Propose clinical study design and develop clinical study protocol based on the clinical development plan. • Be accountable for clinical trial deliverables (e.g., Clinical study protocol, clinical study reports, and submission summary / HA response document). Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. • Provide clinical inputs and resolution for medical issues. • Act as a clinical expert concerning clinical scientific issues of internal and external customers.A. Education /Training background: MD. is mandatory; MSc. or PhD is an asset. B. Knowledge/Skills: • Thoroughly understand and command knowledge of product and relevant diseases • Solid knowledge of clinical development process and HA (especially CFDA) requirements • Thoroughly understand and command GCP • Thoroughly understand and command HCC C. Job experience: At least 3-year working experience in pharmaceutical industry (especially clinical development) Clinical practice experience is preferred D. Competency: Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities. E. Others: Excellent English abilities of listening, speaking, reading and writing; same level of CET-6
Company:
Johnson And Johnson
Posted:
July 2 on Equest
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