**Job Responsibility:
1. Clinical study protocol (CSP) expansion/development/assessment.
2. Development of clinical study report (CSR)/interim and annual report.
3. Investigator’s brochure (IB) development.
4. Study-related document development/ePublishing.
5. Attendance of project meetings with sponsors.
6. Preparation for regulatory/CDE/TFDA/FDA consultations and meetings.
7. Implement the cross-QC system.
8. Communications and coordination of the projects with sponsors
9. Statistical sample size/power consultancy.
10. Perform other company-related duties as assigned by the manager.
工作待遇 : 面議 (年薪14個月+獎金)
**Education/ Qualifications:
1. MSc, PhD, or MD degree in life science/pharmacy/medicine/public htelath, with a minimum of 2-year experience in clinical research or in medical/scientific writing.
2. Quality-oriented, accurate, detail-oriented, and responsible working attitudes to provide deliverables on time.
3. Self-motivated, flexible, creative, able to prioritize, multi-task and work in a fast-paced and demanding environment.
4. Good inter-personal skills and time/project management skills.
5. Good written/oral English and Chinese and other required language skills.
6. Familiar with GCP principles and related ICH guidelines.
7. Good medical/scientific writing and ability to adapt style/content to different readers/audiences.
8. Good editing and QC skills.
9. Good computer skills, including MS Office, PDF formats, scientific graphing.
10. Ability to search different databases, e.g., PubMed.