FSP HGR Specialist

1 week ago

Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

As a leading global contract research organization, Fortrea is dedicated to delivering innovative solutions for pharmaceutical, biotechnology, and medical device customers. We are seeking a highly skilled FSP HGR Specialist to join our team.

Key Responsibilities

  • Support the development and submission of HGR applications, ensuring timely and accurate completion.
  • Implement HGR strategies to maintain low rejection rates and ensure compliance with regulations and internal processes.
  • Oversee HGR compliance during study execution, including submission applications, quality issues, and sample retention.
  • Conduct regular audits and inspections to ensure HGR self-check and report management.
  • Collaborate with authorities and conduct regular training on HGR procedures.
  • Support the development and upgrade of internal HGR systems and SharePoint tools.
  • Maintain HGR submission accounts and perform other tasks assigned by the line manager.

Requirements

  • Bachelor's degree or above in medical, pharmaceutical, or biological science.
  • At least 2 years' experience in clinical operations or related fields, including 1 year's experience in HGR management.
  • Knowledge of drug development and local regulations.
  • Excellent communication and collaboration skills.
  • Fluent in both oral and written English.

Fortrea is committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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