该职位来源于猎聘 此职位需外派Top MNC公司,职位长期稳定,发展空间大。一、岗位核心职责 1. 技术研发支持 o 主导小分子合成、小分子制剂等部门协作 o 提供药学技术支持(合成、生产、剂型开发、稳定性研究、效期确定) o 对接全球技术团队,获取申报所需材料(供中国注册与临床使用) 2. 跨部门协作 o 为注册部(RA)提供申报技术文件(CTA/NAD) o 为临床团队提供临床试验用药(临床供应链管理) o 推动项目进展:从生产→CDE申报→临床供应→试验执行 3. 战略规划 o 参与项目团队(Project Team),代表技术线制定策略 ________________________________________ 二、候选人硬性要求 学历 - PhD(美国或英语国家优先) 专业领域 - 小分子制剂/小分子分析/药学相关领域,需有垂直深耕经验 语言能力 - 技术英语Top水平(全球协作必需) 经验 - 5年左右经验(弹性),跨部门合作经历 > 工作年限 需有与注册、分析、合成组协作的成功案例 Key Responsibilities:Generate CTA/NDA package including timeline, action plan, task tracking log, etc.
for other project leads;Gather local development needs through attending local asset team meetings and interating with other functions, propose China strategy/timeline for your projects, compare local and global plans, identify any gaps between them, highlight risk, and propose mitigation plans;Ensure China plan for your projects, including timing of key deliverables and associated resource/budget forecasts are consistent with candidate milestones, overall China development strategiesRequirement:PhD with technical experiences in drug development disciplines such as API, DP, Analytical, Quality etc.
;Able to fluently communicate in Chinese and English and work outside normal working hour;Portfolio management skills related to project strategies, timeline, resource, and budgets.
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