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Fsp Hgr Specialist (Beijing)

2+ years
Not Disclosed
10 Aug. 2, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

As a leading global contract research organization (CRO) with a deep commitment to scientific excellence and extensive clinical development experience, Fortrea offers a broad spectrum of clinical development, patient access, and technology solutions across over 20 therapeutic areas. With a dedicated team of more than 19,000 professionals operating in over 90 countries, Fortrea is at the forefront of transforming drug and device development worldwide.

Typical Accountabilities:

  • Support HGR application submissions, including online submissions, site filing, tracking, and application form reviews based on study needs.
  • Implement HGR strategies at the operational level to maintain low rejection rates and ensure compliance with regulations and internal processes.
  • Oversee HGR compliance during study execution, addressing issues related to HGR submissions, quality concerns, and sample retention.
  • Conduct self-checks, audits, and inspections related to HGR on a study level, and manage report formats.
  • Act as the primary contact for authority consultations and conduct regular HGR refresher training.
  • Assist in the development and enhancement of the internal HGR system and update HGR SharePoint as an end-to-end tool with a focus on process excellence.
  • Maintain HGR submission accounts and perform other tasks as assigned by the line manager.

Education, Qualifications, Skills, and Experience:

  • Bachelor’s degree or higher in medical, pharmaceutical, biological sciences, or a related field.
  • At least 2 years of experience in clinical operations or related fields, with a minimum of 1 year in HGR management.
  • Knowledge of drug development processes and local regulations.
  • Strong communication and collaboration skills.
  • Fluent in both oral and written English.

Fortrea is actively seeking innovative problem-solvers and creative thinkers who are passionate about overcoming challenges in clinical trials. Our commitment to revolutionizing the development process ensures the rapid delivery of life-changing therapies to patients. Join our dynamic team and thrive in a collaborative environment that supports personal growth and makes a global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea is dedicated to fostering diversity and inclusion in the workforce and does not tolerate any form of harassment or discrimination. Employment decisions are based solely on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital or civil union status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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