- 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.
- 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
Country Approval Speciliast - Beijing, 中国 - Thermo Fisher Scientific
描述
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
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.