Specialist I, HGR Management (FSP）
Primary Location: China, Beijing Additional Locations: China, Remote 求人ID R0000039752 Category Clinical Trials
About this Role
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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