Specialist, Human Genetic Resources (HGR) Management
HybridShanghai, Shanghai, China
Job Summary
Execute Human Genetic Resources (HGR) application activities during study start-up, preparing and submitting applications while collaborating with stakeholders to address delivery issues. Compile ethics and local document packages, ensuring precise online data entry and adherence to compliance standards. Support obtaining HGR and sample exportation approvals, perform quality checks for ALCOA compliance, and maintain detailed tracking and archiving of applications. Monitor HGR compliance for assigned studies, resolving implementation issues with guidance from senior colleagues. Identify opportunities for process enhancements and implement training to stay updated on regulations. This role establishes a country-specific capability within the China CSM team, reporting to the manager of HGR management.
Required Qualifications
- Bachelor's degree in life sciences, medicine, pharmacy, health sciences, or a related field
- At least 2 years of experience in the pharmaceutical industry
- Solid understanding of human genetic resource regulations
- Familiarity with ICH GCP
- Familiarity with clinical trial workflows
- Good communication skills
Desired Qualifications
- Exposure to human genetic resources
- Strong time management skills
- Attention to detail
- Ability to manage multiple tasks in a high-volume work environment
- Proficiency in data tracking and documentation processes
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