Specialist, HGR Management

该职位来源于猎聘 The Specialist, HGR Management is the entry level of HGR Management Team. He/She is responsible for supporting the related activities in HGR application submission, HGR process management and excellence, compliance oversight and inspection readiness.

• Support on HGR application submission, including but not limited to on-line submission, site filing, tracking and application form, format review based on study need in a timely manner.
• Implement HGR strategy at operation level to keep low rejection rate and good compliance in line with the regulation and internal process.
• Support to oversee HGR compliance during study execution, including but not limited in HGR submission application, HGR quality issue, study remaining sample retention.
• Responsible for HGR self-check, audit, inspections on study level and relative report format management.
• Responsible for authority contact and consultation, conduct the HGR regular refreshing training.
• Support the development and upgrade the internal used HGR system.
• Support to the development and update of HGR SharePoint as end-to-end tools with process excellence mindset.
• Key person for HGR submission accounts maintenance, and other tasks assigned by line manager.