HGRAC Specialist

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

Position Purpose:

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

Main responsibilities and accountabilities:

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 CREL/SSUL 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. Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated 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 accountability 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.

Adaptability – maintains effectiveness when experiencing major changes in work responsibilities 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.

Other:

Availability to travel domestically and internationally if required.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。