Job Description:

1.       Develop initial drafts of clinical trial protocols (Phase I, II, and III), investigator brochures, and related documents for innovative drugs based on preclinical studies, clinical research, and relevant literature.

2.       Revise clinical study protocols and provide recommendations on medical strategies for clinical trials.

3.       Assist project managers with relevant administrative tasks; participate in managing and coordinating with external partners (e.g., medical departments of CROs).

4.       Review and respond to medical inquiries from ethics committees.

5.       Perform medical monitoring during clinical trials, review protocol deviation records, address technical questions from investigators and clinical operations teams, and provide professional medical insights.

6.       Collaborate with the Pharmacovigilance (PV) department to prepare Development Safety Update Reports (DSURs) and ensure timely reporting of adverse events (AEs) in compliance with protocols and regulations.

7.       Maintain positive and professional relationships with investigators at clinical trial sites.

8.       Review draft statistical analysis reports (SARs); review or draft clinical study reports (CSRs) and summary reports; review finalized clinical study reports.

9.       Complete other tasks assigned by supervisors.

Requirements:

1.       Bachelor’s degree or higher in Clinical Medicine (preferred), Clinical Pharmacology, Clinical Pharmacy, or a related field.

2.       At least 2 years of relevant experience as a Medical Manager in pharmaceutical companies or clinical CROs; experience as a Medical Specialist is preferred. Familiarity with ICH-GCP and Chinese GCP regulations.

3.       Experience in medical writing (literature review, protocol drafting, summary report writing); familiarity with drug registration regulations and ICH guidelines.

4.       Strong learning, communication, and coordination skills; ability to work independently and solve problems effectively.

5.       Proactive attitude, excellent teamwork spirit, and a strong sense of responsibility.