公司简介

"华东医药长在,生命之树常绿"
●管理整个项目流程(会有相应培训如需要),包括药理、DMPK、CMC、安全性评价(毒理、病理分析/生物分析)等研究
Manage the entire project process (with appropriate training if needed), including pharmacology, DMPK, CMC, safety assessment (toxicology, pathology analysis / bioanalysis)
协调CRO和内部专家达到监管要求,最终支持药物发现和开发项目达到项目(申报)要求
Coordinate CROs and internal experts to meet regulatory requirements and ultimately support drug discovery and development projects to meet project (reporting) requirements.
●在项目管理中始终处于主动地位,随时跟进监管和申报要求并持续地给予支持,主动地发现潜在问题并提出建设性建议
Always in a proactive position in project management, follow up on regulatory and reporting requirements and continue to support, proactively identify potential problems and make constructive suggestions.
●准备生物分析、药理学、DMPK或/和安全性评价的注册文档(会有相应培训如需要),查阅并准备项目所需要的科学文献。
Prepare registration documents for bioanalysis, pharmacology, DMPK or/and safety evaluation (with appropriate training if needed), review and prepare the scientific literature required for the project.
●根据项目进展与公司内的其他核心部门沟通,与项目团队和更高层级管理人员高效地沟通项目开发计划和研究结果。
Communicate with other core departments within the company based on project progress, and effectively communicate project development plans and research results with project teams and higher-level managers.
●与内部项目组建立良好的关系。
Establish a good relationship with the internal project team.
●有责任心,能在短时间内提升个人能力。良好的人际沟通技巧和团队精神。
Responsible, able to improve personal ability in a short period of time. Good interpersonal skills and teamwork.
●主动和有技巧地协调CRO,有效率地推进工作。有轻重缓急意识,始终按照时间节点去推动项目进展。
Proactively and skillfully coordinate CROs to advance work efficiently. Have a sense of prioritization and always follow the time node to promote the progress of the project.
●出色的自我管理能力和组织协调能力,与跨部门团队高效工作的能力。
Excellent self-management and organizational coordination skills, and the ability to work efficiently with cross-functional teams.
●清晰和精确的口头和书面沟通能力。
Clear and precise verbal and written communication skills.
●熟悉药物开发监管指南,具备丰富的实验室经验和/或良好的英语书面/口语沟通能力优先。
Familiar with drug development regulatory guidelines, with extensive laboratory experience and/or good written/speaking communication skills in English.
●博士学历具有至少3年相关经验,或硕士学历具有至少5年相关经验,或本科毕业具有至少5-8年相关经验, 必须有毒理经验/项目管理经验, 其他经验包括体外/体内、药理学、DMPK。相关经验包括CRO工作经验。需要有生物科学教育背景。
Ph.D. degree with at least 3 years of relevant experience, or master's degree with at least 5 years of relevant experience, or undergraduate degree with at least 5-8 years of relevant experience, must have toxicological experience / project management experience, other experience including in vitro / in vivo, pharmacology , DMPK. Relevant experience includes CRO work experience. A background in biological science education is needed.