HGRAC Specialist

About the Role:

The HGRAC Specialist is a key member of our team at Parexel, responsible for ensuring seamless HGRAC application processes for insourced and outsourced studies in China.

Main Responsibilities:

• Submit and review HGRAC applications, including online application forms, paper documents, and dossier submissions, in accordance with HGRAC regulations.
• Track online application results and provide regular updates to HGRAC officers, collaborating with CSM/CPL teams to develop application strategies and potential solutions.
• Stay up-to-date with the latest HGRAC-related regulations and serve as a subject matter expert to improve Roche's HGRAC application process, management processes, and functional initiatives.
• Provide timely and accurate HGRAC information to global and local internal stakeholders, supporting management in strategic decision-making.
• Establish and maintain databases to capture updated HGRAC regulations, lessons learned, and FAQs.
• Participate in professional meetings, symposia, and continuing education programs to maintain knowledge and expertise across the industry.
• Perform other tasks as assigned or requested by line management.

Qualifications:

• University Degree or equivalent in a medical or science-related field.
• Knowledge and understanding of clinical trials and experience in managing projects.
• Knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP) and regulatory requirements for starting clinical trials in relevant countries.

Competencies:

• Planning and Organizing: Establishes action plans for self and others to complete work efficiently and on time.
• Communication: Conveys information and ideas clearly and concisely to individuals or groups.
• Building Partnerships: Develops and leverages relationships within and across work groups to achieve results.
• Initiating Action: Takes prompt action to accomplish work goals and takes actions to achieve results beyond what is required.
• Work Standards: Sets high standards of performance for self and others and assumes responsibility for successfully completing assignments or tasks.
• Decision making: Identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information.
• Adaptability: Maintains effectiveness when experiencing major changes in work responsibilities or environment.
• Influencing: Uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions.
• Innovation: Creates novel solutions with measurable value for existing and potential customers.
• Customer Orientation: Places a high priority on the internal or external customer's perspective when making decisions and taking action.
• Technical/Professional Knowledge and Skills: Has achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas.