Specialist, Human Genetic Resources (HGR) Management
Core
Execute Human Genetic Resources (HGR) application activities, prepare and submit regulatory dossiers, and ensure compliance with local regulations and ICH GCP standards for clinical studies in China.
Role type
Specialist, Human Genetic Resources (HGR) Management
Builds
Regulatory approvals and compliant study start-up operations for clinical trials
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
HGR application execution, dossier preparation, regulatory compliance monitoring, data tracking and archiving, document compilation, quality checks (ALCOA), cross-functional collaboration
Preferred skills
ICH GCP knowledge, clinical trial workflows, data management proficiency
Technologies
None stated
Responsibilities
Execute HGR application activities and prepare submissions, compile ethics and local document packages, support obtaining HGR and sample exportation approvals, manage document collection and quality checks from sites, track and archive HGR application data, monitor compliance for assigned studies, collaborate with stakeholders on project alignment, identify process improvement opportunities, engage in regulatory training programs
Seniority
Individual Contributor, Specialist level
