This role establishes a country specific capability within the China CSM team and direct report to the manager of HGR management. The HGR Specialist is responsible for executing HGR application activities during the study start-up period, ensuring compliance with regulations and supporting efficient project operations.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• HGR Application and Maintenance Execution: Execute HGR application activities, focusing on the preparation and submission of applications. Collaborate with key stakeholders to ensure timely and high-quality delivery of HGR applications, addressing and communicating any issues that affect delivery.
• HGR Submission and Data Management: Assist in the preparation and submission of HGR applications, ensuring precise online data entry and dossier preparation.
• Document Compilation and Submission: Compile and submit all required ethics and local document packages, ensuring accuracy and adherence to compliance standards.
• Regulatory Compliance and Approvals: Support activities necessary for obtaining HGR and sample exportation approvals, ensuring alignment with regulations.
• Regional Collaboration: Help manage the collection of essential documents from sites, performing quality checks to ensure ALCOA compliance.
• Data Tracking and Archiving: Maintain detailed tracking of HGR applications and approvals, ensuring thorough documentation archiving for compliance.
• Compliance Monitoring: Monitor HGR compliance for assigned studies, resolving implementation issues with guidance from senior colleagues.
• Cross-Functional Collaboration: Work collaboratively with key stakeholders to ensure the HGR application process aligns with project goals, focusing on effective communication and coordination.
• Process Improvement: Identify opportunities for minor process enhancements and assist in their implementation.
• Knowledge Enrichment: Engage in training programs to stay updated on HGR regulations and industry best practices.