职位描述
• Contribute to clinical development strategies and develop trial outline and/or full protocol for phase 3 and phase 4 studies based on regulatory requirement and business needs to generate clinical data for new product approval and strengthen product life cycle management
• Take medical responsibility in clinical trial execution with high scientific and ethical standards to ensure the quality of clinical trial for regulatory submission and promotion use
• Generate key clinical documents and interact with Health Authority to achieve timely CTA/NDA submission and approval
• Build up relationship with KOLs/Investigators to influence them to accommodate and overcome medical or treatment procedure barriers in clinical programmes to facilitate trial execution and advocate company’s products
• Provide medical expertise in Trial Outline review within Diabetes filed to contribute to global development
• Coach medical scientists regarding the general and professional competencies, skills and knowledge in order for them to accomplish their accountabilities
企业介绍
是一家致力于人类健康、以先进的生物技术造福患者、医生和社会的世界领先生物制药公司。现今在全球79个国家设有分支机构,6个国家设有生产厂,员工超过30,000人,销售遍及180个国家。