Job Description:
1.Responsible for writing, reviewing, and revising clinical trial protocols, Investigator Brochures (IB), Case Report Forms (CRFs), informed consent forms, patient diary cards, and other related documents.
2.Lead the writing, review, and revision of clinical study reports (CSRs) and clinical overviews, and assist with IND submissions.
3.Provide medical support in project development, market research, and clinical strategy formulation, including internal/external medical communication and training.
4.Offer medical support across all stages of drug development projects, including but not limited to:
a.Communicate with clinical medical experts regarding clinical trial design as needed.
b. Participate in clinical protocol discussion and summary meetings as a speaker, review meeting minutes, and provide academic support.
c.Conduct medical monitoring at the study level, including eligibility/recruitment audits and protocol deviation reviews.
d.Engage in clinical trial initiation, patient eligibility reviews, medical monitoring, document writing/reviewing, and maintain professional communication with internal/external experts.
e.Collect, record, analyze, and report trial safety data, chair safety review meetings, and communicate safety findings with experts.
f.Review and revise SAE (Serious Adverse Event) and DSUR (Development Safety Update Report) submissions.
5.Establish and oversee company drug safety policies and management systems.
6.Perform other duties assigned by leadership.
Qualifications:
1.Master's degree or higher in clinical medicine or related fields; background in autoimmune diseases/dermatology preferred.
2.3+ years of medical/medical monitoring experience; biopharmaceutical/innovative drug experience preferred.
3.Deep understanding of clinical trial regulations/guidelines and disease-specific clinical guidelines (e.g., autoimmune/dermatology).
4.Strong literature research, writing, and presentation skills in English/Chinese.
5.Proficient in office software; statistical analysis skills a plus.
6.Highly responsible, ethical, resilient, with excellent organizational/communication skills.
7.Willingness to travel.