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HGRAC Compliance Specialist

2 months ago

Beijing, Beijing, China Parexel Full time

When our values align, there's no limit to what we can achieve.

Position Overview:

The HGRAC Compliance Specialist plays a crucial role in managing all HGRAC applications for both insourced and outsourced studies within the region.

Key Responsibilities:

  • Oversee HGRAC submissions and evaluations, ensuring compliance with regulations through the completion of online forms, collection of necessary documentation, and submission of paper dossiers.
  • Monitor online application outcomes, providing regular updates to the HGRAC officer regarding any rejections and collaborating with relevant teams to strategize on application improvements.
  • Stay informed on the latest HGRAC regulations and serve as a subject matter expert, contributing to the enhancement of Roche's HGRAC application processes and management initiatives.
  • Disseminate updated HGRAC information to both global and local stakeholders, assisting management in strategic decision-making.
  • Establish and maintain a comprehensive database to document HGRAC regulations, lessons learned, and frequently asked questions.
  • Engage in professional meetings, symposiums, and educational programs to uphold industry knowledge and expertise.
  • Execute additional tasks as assigned by the line manager.

Qualifications:

  • A University Degree or equivalent, ideally in a medical or science-related discipline.
  • Proficient understanding of clinical trials and experience in project management.
  • Familiarity with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practices (ICH-GCP), along with knowledge of regulatory requirements for initiating clinical trials.

Competencies:

  • Planning and Organizing: Develops actionable plans to efficiently complete work by prioritizing tasks and managing timelines.
  • Communication: Effectively conveys information in a clear and engaging manner, ensuring understanding and retention.
  • Building Partnerships: Cultivates and utilizes relationships across work groups to achieve objectives.
  • Initiating Action: Proactively takes steps to achieve work goals and exceed expectations.
  • Work Standards: Maintains high performance standards and takes responsibility for completing assignments successfully.
  • Decision Making: Analyzes problems and opportunities to make informed decisions that optimize outcomes.
  • Adaptability: Adjusts effectively to changes in responsibilities or environment, collaborating with others to ensure successful transitions.
  • Influencing: Employs persuasive strategies to gain acceptance of ideas and commitment to actions.
  • Innovation: Develops creative solutions that provide measurable value and explores new approaches to problem-solving.
  • Customer Orientation: Prioritizes the needs of internal and external customers in decision-making processes.
  • Technical Knowledge: Demonstrates a satisfactory level of expertise in relevant areas and stays updated on industry trends.