1. Job Purpose and Key Responsibilities 岗位的目的和主要岗位职责:
Provide medical inputs and support for clinical trials and newproduct registration in China Specialty Care Therapeutic Area.
2. Accountability 责任:
1) Provide medical input into clinical studies involving China ? Develop appropriate protocol synopsis and protocols to supportresearch proposals and meet local registration need ? Actively participate feasibilities at program, protocol and sitelevel for global/regional studies, and provide timely and quality feedback ? Perform medical monitoring for the studies in charge ? Assist with study operation team in coordinate with Investigatorand leading site selection ? Prepare and deliver presentations for product and protocolintroduction at investigator meetings and trainings to study team ? Act as protocol and clinical lead in a study team, approveprotocol deviations, analyze AEs/SAEs, and answer clinical and productqueries from investigators ? Provide valuable inputs in statistical analysis plan finalizationand efforts in achieving database clean ? Prepare and finalize local clinical study report, and assiststudy result publication
2) Provide medical support to deliver regulatory submissions(IND andNDA, etc) ? Relevant medical document preparation ? Support communication with regulatory agency(including panelmeetings, etc) and relevant material preparation
3) Ensure governance across all clinical activities ? Ensure a high level of self directed understanding, disseminationand teaching of the GSK policies and SOPs ? Ensure the safe and ethical conduct of trials ? Medical governance of activities before asset launch in Chinaunder scientific engagement principles
4) Perform as project leader to be accountable for China developmentstrategy for early stage compound in Specialty Care.
3. Specialized Knowledge 专业知识:
Basic Requirements: Must be non-comparative, objective and relevant. Critical/essential toaccomplish the role ? ≥2 years hospital physician experience ? ≥1 years industry clinical research experience, or ≥2 yearsindustry medical affairs physician experience. ? Minimum Master degree in clinical medicine ? Knowledge of clinical development process and GCP ? Interpersonal communication skill; ? Excellent written/verbal communication skills in English ? Basic knowledge of Project Management ? Knowledge of and regulatory requirements ? Knowledge of PC (WORD, EXCEL, POWERPOINT); ? Presentation skill
Preferred Requirements: Relevant to the role, but not critical/essential ? Clinical Research Physician experience in industry ? Experience in conducting clinical studies as medical monitor