人遗办专员-北京（Contract）

职位描述

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.

任职要求

• Bachelor or above in medical, pharmaceutical, and biological science and equivalent

• At least 2 years’ experience in clinical operations or other related fields, including 1 years’ experience in HGR management.

• Have knowledge of drug development and local regulations.

• Good communication and collaborative skills.

• Fluent in both oral and written English.

• Have ability to prepare and deliver study related training materials