Specialist, HGR Management

该职位来源于猎聘 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*

• Support CTM with the preparation of HGR submission dossier
• Quality review on all HGR submissions according HGRAC regulations
• Manage all BI HGRAC accounts, especially the administrative account with timely support for all BI HGR submission
• Regular update for the HGR related information
• Tracker management, documentations archiving
• Maintain execution status of HGR activities, including but not limit to track bio sampling activities
• Perform other tasks, as assigned or requested Minimum Education/Degree Requirements* Bachelor's degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences. Required Capabilities (Skills, Experience, Competencies) *
• Minimum 2+ years working experience in pharmaceutical industry, ideally with HGR related experience
• Good understanding of HGR regulations
• Good understanding of ICH GCP, and related working knowledge and processes in clinical trials
• Good time management skills, detail oriented, and ability to manage multiple tasks in a high-volume environment with shifting priorities
• Good communication skills
• Quick learner, good team player
• Fluent in reading, writing and speaking English