1. Medical Writer
1) Provide relevant literature retrieval fproducts, the progress of clinical studies other information.
2) Develop clinical documents: full protocol, ICF, CSR, IB, summary of clinical efficacy safety, etc.
3) Prepare abstracts, posters, slide presentations publications in collaboration with investigators, clinical team members based on results from clinical trials.
4) Maintain up-to-date knowledge competencies within relevant therapeutic professional areas.
2. Medical Monitor
1) Work with Medical Writer to review clinical documents.
2) Responsible accountable foverall supervision/execution of medical validation/review of study data, including writing supervision of study related documents (e.g., medical monitoring plan, guidelines, etc.).
3) Act as a key driver to work on clinical projects, provide medical scientific expertise to project teams, participate in project feasibility risk assessment.
4) Conduct medical safety monitoring, review clinical lab values, AEs/SAEs, coding dictionaries assist with data safety monitoring board activities, etc.
MINIMUM REQUIREMENTS
1) Masters degree above in Medical science.
2) Fluent English on both written & verbal.
3) Ability to accurately clearly present clinical data, inal written.
4) Good communication skills teamwork spirit.
5) Good agility to learn new knowledge.
6) Ability to work independently, to handle multiple tasks simultaneously.
7) Doctor’s license and/work experience in hospital clinical development is a plus.