職位描述
? 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
企業(yè)介紹
是一家致力于人類健康、以先進的生物技術(shù)造?;颊摺⑨t(yī)生和社會的世界領(lǐng)先生物制藥公司?,F(xiàn)今在全球79個國家設(shè)有分支機構(gòu),6個國家設(shè)有生產(chǎn)廠,員工超過30,000人,銷售遍及180個國家。