Ctry Approval Spec

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital, and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose

The HGRAC CAS is responsible for all HGRAC applications for Clinical Operation studies in China, or Standalone Projects of contract sponsor. This position also supports human genetic resource management during the clinical trial implementation.

Key Responsibilities

• •Prepare HGRAC application documents based on related guidance and regulation, including but not limited to the fulfillment of the online application form, and document collection.
• •Review and approve HGRAC application documents. Execute QC process if needed internal PPD.
• •Tracking of online application results, following application status and feedback to the study team, contacting with HGRAC officer for specific questions if needed, and providing potential solutions.
• •Be familiar with the most updated HGRAC-related regulations and sensitive to the details updates of HGRAC notifications, requirement updates, and online system adjustments.
• •Provide updated HGRAC information to global and local internal delivery teams and support management on strategic decision-making.
• •Set up and maintain the database to capture updated HGRAC regulations, lessons learned, and FAQs.
• •As the functional leader in the HGRAC amendment submission activities.
• •Perform other tasks, as assigned or requested by the line manager.

Keys to Success

Education and Experience:

Bachelor’s degree or above, preferably in a science / medical-related field. Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated knowledge and understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory requirements of HGRAC, NMPA, CDE, etc.

Knowledge, Skills, and Abilities

• •Effective oral and written communication skills
• •Excellent interpersonal skills
• •Strong attention to detail and quality of documentation
• •Good negotiation skills
• •Good digital literacy and the ability to learn appropriate software
• •Good English language and grammar skills
• •Basic medical/therapeutic area and medical terminology knowledge
• •Ability to work in a team environment or independently, under direction, as required
• •Basic organizational and planning skills
• •Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations