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医药 / 医疗器械 / 生命科学行业
(Senior) Clinical Research Physician, Immunology & Dermatology
Major Responsibilities:
- Ensure all clinical studies operate to the highest level of ethical and safety standards and in compliance with GCP, SOPs and regulatory requirements
- Responsible for study design, protocol development, preparation for relevant study document, providing medical support to Clinical Operation team, resolving medical issues, study reporting and publication
- Act as protocol and clinical lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators
- Timely communicate with global asset/project team to ensure global/China alignment
- Closely work with therapeutic matrix team to develop China product and portfolio strategy and obtain alignment from key stakeholders
- To take leadership to ensure the development and registration strategies are implemented as planned
- Help to develop relevant regulatory dossier for regulatory submission and provide medical support to communication with regulators as necessary
- Maintain high level of clinical understanding of products and assigned disease areas, provide knowledge training to study team as needed
- Establish and Maintain an effective network of relationships with key opinion leaders in assigned disease areas.
Requirement:
- Clinical medicine education background & at least 3 years experience in medical practice
- Basic Knowledge of clinical development process, and regulatory requirements
- At least 3 years experience in pharmaceutical industry
- Good command of English (written and spoken)
- Knowledge of PC (WORD, EXCEL, POWERPOINT)
若您有意此职位,请发送个人简历到 resume@impresschina.com
If you are interested in this position, please send resume to resume@impresschina.com