公司提供丰厚的薪资福利: 五险一金,补充公积金,生日/节假日礼品券,spotlight积分兑换商品 额外津贴:住房补充,交通,餐饮,采暖(仅适用于中国北方地区)等各种津贴 员工健康:补充商业医疗保险,年度健康体检 长期发展:内部转岗机会,丰富的线上线下培训 专业培训:Clinical Training Institute的专业支持,赛纽仕的CRA培训计划由IAOCR认证并颁发相应证书
Basic purpose of the job* The Specialist, HGR Management is responsible to support the HGR submissions and achieve the approvals within aligned timeline and fulfill required duties for HGR related activities. Accountabilities* 61 Support CTM with the preparation of HGR submission dossier 61 Quality review on all HGR submissions according to HGRAC regulations 61 Manage all BI HGRAC accounts, especially the administrative account with timely support for all BI HGR submission 61 Regular update for the HGR related information 61 Tracker management, documentations archiving 61 Maintain execution status of HGR activities, including but not limit to track bio sampling activities 61 Perform other tasks, as assigned or requested Minimum Education/Degree Requirements* Bachelor Degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences. Required Capabilities (Skills, Experience, Competencies) * 1. Minimum 2+ years working experience in pharmaceutical industry, ideally with HGR related experience 2. Good understanding of HGR regulations 3. Good understanding of ICH GCP, and related working knowledge and processes in clinical trials 4. Good time management skills, detail oriented, and ability to manage multiple tasks in a high-volume environment with shifting priorities 5. Good communication skills 6. Quick learner, good team player 7. Fluent in reading, writing and speaking English