Description
We are seeking a Medical Advisor to join our team.
Responsibilities:
- Prepare and organize discussion activities for various clinical research programs, and closely communicate with principal investigators or experts in the treatment field regarding research programs.
- Responsible for medical writing related to clinical research projects, such as writing clinical research plans and clinical research summary reports, according to company SOPs and client requirements.
- Conduct medical review of projects, including reviewing research plans, informed consent forms, investigator's manuals, case report forms, statistical analysis plans, clinical research summary reports, and medical coding of adverse events.
- Develop medical monitoring plans according to company SOPs and project requirements, ensuring project quality and safety, including but not limited to SAE and protocol deviation monitoring.
- Provide project support to clinical operation teams, including participating in site feasibility assessments, selecting principal investigators, and conducting initial medical discussions with them.
- Provide medical training and support to project teams or investigators, including preparing medical training materials, providing relevant treatment field medical knowledge, and program training.
- Attend investigator meetings to present medical-related content (if needed).
- Participate in project kick-off meetings, research team meetings, and client meetings as needed.
- Provide medical support for new project proposals to the BD team, meeting with clients if necessary to discuss medical issues related to the program.
- Establish good communication relationships with medical experts in key areas, regularly visiting academic experts, updating medical progress information, and maintaining good cooperative relationships with them.
- Write SOPs related to the department as required.
- Establish good cooperative relationships with other departments in the company.
- May require irregular business trips as needed.
- Efficiently complete tasks assigned by direct managers.
Requirements:
- Rich clinical trial knowledge background.
- Understanding of clinical trial-related regulatory requirements, such as China's GCP, ICH-GCP, etc.
- Proficient in using Microsoft Word, PowerPoint, and Excel software.
- Good oral and written communication skills (including proficient English).
- Good presentation skills and training skills.
- Strong collective awareness and good teamwork spirit;
- Ability to establish and maintain effective working relationships with colleagues, managers, and clients.
Education and Experience:
- Bachelor's degree or higher in clinical medicine, or master's degree or higher in pharmaceutical-related majors.
- Bachelor's degree requires 3 years or more of medical advisory or hospital clinical or clinical research experience;
- Master's degree requires 2 years or more of medical advisory or hospital clinical or clinical research experience;
- Doctoral degree requires 1 year or more of medical advisory or hospital clinical or clinical research experience;
- Equivalent education, training, and experience are preferred.