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Position Purpose:

The HGRAC Specialist is responsible for all HGRAC applications for insourced and outsourced studies in China.

Main responsibility:

Be responsible for HGRAC submission and review, including but not limited to the fulfillment of online application form, paper documents collection and paper dossier submission etc according to HGRAC regulation. Be responsible for the tracking of online application results. Regular update HGRAC officer for the reason of rejection and work together with CSM/CPL for the application strategy and potential solution. Be familiar with the most updated HGRAC related regulation and act as subject matter expert to provide input for continuous improvement of Roche HGRAC application process set up, relevant management process and functional initiatives. Provide updated HGRAC information to global and local internal stakeholders and support management on strategic decision-making. Setup and maintain database to capture updated HGRAC regulations, lessons leant and FAQ. Participate in appropriate professional meetings, symposia, and continuing education programs to maintain knowledge and expertise across the industry. Perform other tasks, as assigned or requested by line manager.

Qualifications:

University Degree or equivalent, preferably in medical / 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, Good Clinical Practices(ICH-GCP), as well as understanding of the regulatory requirements for starting clinical trials in the relevant country.

Competencies:

Planning and Organizing – establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources. Communication – conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others. Building Partnerships – develops and leverages relationships within and across work groups to achieve results. Initiating Action - takes prompt action to accomplish work goals; takes actions to achieve results beyond what is required; is proactive. Work Standards – sets high standards of performance for self and others; assumes responsibility and account client for successfully completing assignments or tasks; self –imposes standards of excellence rather than having standards imposed. Decision making – identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences. Adapt client– maintains effectiveness when experiencing major changes in work responsibly or environment (e.g., people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful. Influencing – uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes. Innovation – creates novel solutions with measurable value for existing and potential customers(internal or external); experiments with new ways to solve work problems and seizes opportunities that result in unique and differentiated solutions. Customer Orientation – places a high priority on the internal or external customer’s perspective when making decisions and taking action; implements service practices that meet the customer’s and own organization’s needs. Technical / Professional Knowledge and Skills – has achieved a satisfactory level of technical, functional, and / or professional skill or knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.

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