HGR Specialist
BEIJING, Beijing, China 职位编号 R0000039522 类别 Clinical Trials关于这个职位
Job title *
Specialist I, HGR Management
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
- Prepare and complete HGR application forms in internal and regulatory authority systems in compliance with BI SOPs, ensuring high quality and regulatory standards
- Support communication with HGR regulatory authorities on inquiries and consultations, and assist in identifying appropriate resolutions
- Support conducting quality review on all HGR submissions according to HGRAC regulations
- Regular update for HGR related information
- Tracker management, documentations archiving
- 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) *
Minimum 1+ 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
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