长沙招聘

Key accountabilities:
1. Search and summarize pharmacological data, safety data and clinical data for drug or consumer products, with topical products and natural products as the focus
2. Independently prepare application documents for China filing in Chinese, and global filing in English including translation of pharmacological data, safety data and clinical data from English into Chinese, or vice versa
3. Participate in project assessment and selection, product due diligence; analyze the product’s pharmacological data, safety data and clinical data
4. Other work as assigned by the senior management

Requirements:
1) Master or Ph.D. or MD degree in the relevant field of medicine or life sciences
2) Strong R&D experience and regulatory affairs experience a plus
3) Broad industry knowledge, in-depth understanding of the mechanism of action of medicines, drug discovery and development, clinical development, and post-market drug performance monitoring.
4) Excellent written English and Chinese skills; familiar with literature searching both in Chinese and English; fluent oral English a plus
5) Ability to extract relevant data and perform in-depth analysis of the data
6) Ability to clearly and concisely articulate the information verbally and in writing
7) Ability to recommend regulatory filing strategy and collaborate/ influence regulatory agencies
8) Familiar with Dossier requirements and CTD format for China and global submissions
9) Proactive, committed, reliable, a problem solver with sense of urgency and can-do attitude
10) Must be a team-player; collaborate well with internal and external stakeholders.

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。