HGRAC Specialist II - FSP

Key Accountabilities:

HGRAC Supports

• 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 Client HGRAC application process set up, relevant management process and functional initiatives 

• Provides updated HGRAC information to global and local internal stakeholders and support management on strategic decision-making 

• Setups and maintains database to capture updated HGRAC regulations, lessons leant and FAQ 
• Participates in appropriate professional meetings, symposia, and continuing education programs to maintain knowledge and expertise across the industry 
• Performs other tasks, as assigned, or requested by line manager

Compliance with Parexel standards

• Complies with required training curriculum  

• Completes timesheets accurately as required  

• Submits expense reports as required  

• Updates CV as required  

• Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements 

Skills:

• 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 acting; implements service practices that meet the customer’s and own organization’s needs. 

• A flexible attitude with respect to work assignments and new learning.  

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.  

• Willingness to work in a matrix environment and to value the importance of teamwork. 

• Good in written and spoken English. 

Knowledge and Experience:  

• Demonstrated knowledge and understanding of clinical trials and experience in project management. 

• Demonstrated knowledge and understanding of ICH-GCP and regulatory requirements for starting clinical trials in China.  

• >1 year (2 years is preferred) of proved experience in HGRAC activities in clinical trials conducting in China. 

• Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results. 

Education:

• University Degree or equivalent, preferably in medical/science-related field.