南京招聘

工作职责:

1. 负责新药申报IND项目的知情同意书、临床相关综述和临床试验研究手册的撰写

2. 与第三方合作临床专家对接，完成I期临床试验的设计以及II，III期的临床试验的计划和大纲，协助新药临床开发策略的制定和实施

3. 设计、修订试验药品使用说明书资料

4. 跟踪查阅国内外相关学术资料，进行相关品种的医学调研，分析相关医学信息，为新药项目团队提供医学支持，并配合其他部门进行项目调研和咨询

5. 协助解读临床有效性及安全性

1. Get and stay current of knowledge for relevant academic materials at home and abroad, analyze relevant medical information, provide medical support to new drug project teams, and cooperate with other departments to carry out project research and consultation;

2. Be responsible for the integration of all kinds of scientific research data in the IND phase, and write the investigator brochures;

3. According to the needs of clinical projects, cooperate with clinical experts from third parties and review with experts to carry out the communications about clinical trial outline and clinical protocol design, so as to assist in the formulation and implementation of new drug clinical development strategies.

4. Communicate with the sponsor about the clinical protocol, responsible for the writing, revising and reviewing of clinical sections to be included in the registration dossier, including clinical protocols, original record forms, informed consent forms (CRF), investigator brochures, clinical reports and summaries, and so on;

5. Communicate with the sponsor about the design and revisions of the drug label;

6. Interpretation of clinical effectiveness and safety;

任职资格:

1、 硕士以上学历，临床医学及相关专业；

2、 有外企或大型CRO公司3年以上临床项目经验，1年以上项目负责人、医学部经理经历者佳；

3、 熟悉新药研发的全过程和新药申报的要求，熟悉国内外临床研究发展与现况；

4、 熟悉药品注册管理办法、GCP法规以及有关临床研究的相关法规；

5、 精通医学专业文献检索，并有较强的信息总结和资料撰写能力；

6、 具有良好的沟通能力和解决问题能力；

7、 具有良好的英文写作和听说能力。

1. Master degree or above in Clinical Medicine;

2. More than 3 years of clinical experience in foreign enterprises or large CRO companies, at least 1 year experience of project management or medical manager is preferred;

3. Familiar with the whole process of new drug research and development and the requirements of new drug application, familiar with the development and current situation of clinical research at home and abroad;

4. Knowledgeable about drug registration provision, GCP, and regulations related to clinical trial development;

5. Be good at medical literature searching, writing and summarizing;

6. Good communication ability and problem solving ability;

7. Good English writing, speaking, listening, and understanding.

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。