FSP HGR Specialist

6 months ago

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

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Typical Accountabilities

Support on HGR application submission, including but not limited to on-line submission, site filing, tracking and application form, format review based on study need in a timely manner. Implement HGR strategy at operation level to keep low rejection rate and good compliance in line with the regulation and internal process. Support to oversee HGR compliance during study execution, including but not limited in HGR submission application, HGR quality issue, study remaining sample retention. Responsible for HGR self-check, audit, inspections on study level and relative report format management. Responsible for authority contact and consultation, conduct the HGR regular refreshing training. Support the development and upgrade the internal used HGR system. Support to the development and update of HGR SharePoint as end to end tools with process excellence mindset. Key person for HGR submission accounts maintenance, and other tasks assigned by line manager.

Education, Qualifications, Skills and Experience

Bachelor or above in medical, pharmaceutical, and biological science and equivalent At least 2 years’ experience in clinical operations or other related fields, including 1 years’ experience in HGR management. Have knowledge of drug development and local regulations. Good communication and collaborative skills. Fluent in both oral and written English.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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