Medical Writer 醫學寫作 (可在家工作)

Job Responsibilities: 1. Development of clinical study report (CSR). 2. Assistance in development of clinical study protocol (CSP), common technical document (CTD), investigator’s brochure (IB), and master informed consent form (ICF). 3. Development, QC, and review of trial related documents. 4. E-Publishing (M5). 5. Preparatory activities for consultations and meetings with regulatory/CDE/TFDA/US FDA. 6. Preparation and attendance of project meetings and sponsor meetings. 7. Medical review of clinical trial coding and safety data. 8. Perform other company-related duties assigned by the supervising manager. **Education/ Qualifications: 1. MSc, PhD, or MD degree in life science/pharmacy/medicine 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 in a timely manner. 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.