Medical Writer, Ph.D degree

Responsibilities:

1. Design and develop protocols, informed consent forms, and case report forms.
2. Write clinical study reports and brochures for clinical investigators.
3. Draft Common Technical Documents for submissions, such as IND and NDA.
4. Prepare integrated reports, annual updates, and specialized scientific reports.
5. Conduct regulatory gap analysis.
6. Evaluate products and perform scientific literature searches, reviews, and information synthesis.
7. Fulfill other duties as assigned by the director.

Requirements:

1. Ideal candidates will hold a Ph.D. degree with experience studying abroad. At least 3 years of experience in the biotech or pharmaceutical industry.
2. Proficient in trial design, data analysis, and conducting clinical trials.
3. Skilled in writing, preparing, and reviewing clinical documents.
4. Strong understanding of medical and clinical terminology.
5. Solid scientific reasoning and basic statistical knowledge.
6. Excellent English skills in writing, presentation, listening, and communication.
7. Capable of working independently and within a team in a diverse and dispersed environment.
8. Open to training and career development in the medical science field.