爱上海419论坛_阿拉上海后花园论坛(上海龙凤shlf1314)

陈女士 11小时前在线已认证

HR · HiRO

聊一聊

职位介绍: 职责描述： work with medical and clinical physician team this role is to manage all clinical study related medical writing activities to meet customer clinical trial project needs. Build and maintain good medical writing relationships across all functional units within the company. • Conduct and manage medical writing activities • To manage and carry out clinical study related medical writing including IB, study synopsis, protocol, CSR, clinical document translation. • To ensures all final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the international conference on harmonization (ICH). • To plan, schedule, review, approval, and track all assigned medical writing activities in close cooperation with the teams to ensure that medical writing deliverables meet the project specifications and produced within the timelines to defined quality, and content standards at each point in the document life cycle. • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents. • To work with Regulatory Quality Assurance throughout clinical regulatory document audit process. • To manage and assist the documentation preparation for regulatory submissions in collaboration with regulatory and BD teams under client specifications. 任职要求： • Minimum Bachelor degree in Medicine, pharmacology, or related life science degrees (or equivalent); Master will be a plus. • This work can be homebase. • Experience in medical writing or clinical science or equivalent fields in biopharmaceutical or CRO companies, plus solid experience in complex project management or large scale registration trail project • Solid knowledge in clinical research process and understand submission requirements • Excellent scientific and technical writing skills in both Chinese and English • Detail oriented to consistency, grammar, syntax, and scientific accuracy for deliverables. • Well-developed of time management, communication, presentation, analytical and interpersonal skills. • Excellent Chinese and English written and verbal communication skills

公司简介

上海贺维斯特医药科技有限公司Harvest Integrated Research Organization(HiRO)，是一家立足中国，面向世界的创新临床研究组织（CRO），总部设立在上海。公司具有国际运营与整合能力，始终致力于为全球客户提供全流程服务及解决方案。我们的目标是成为一个市场先进的、综合的全球临床研究组织，与蒸蒸日上的生物技术和生物制药公司一同不断推动医药产品从实验室走向市场。作为医药企业的亲密合作伙伴，我们以有效利用真实世界数据为基础，加之“管家”服务精神，提供全方位的定制化服务。

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