广州招聘

岗位职责：

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

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。

Description for Medical Manager and above:

Key job responsibilities:

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;
   

   Qualifications:
   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.

广州领晟医疗科技有限公司2012年成立于广州科学城，是一家创新模式的新型医药研发企业，专注于新靶点创新药物的引进与开发，国家高新科技企业。广州领晟积极参与全球医药领域的新品种与新技术的引进与开发，已同包括在美国，加拿大，欧洲等多个医药市场的知名医药企业建立了广泛的合作关系，储备了丰富的合作资源，已经形成了颇具规模的研发管线。
目前广州领晟完成多层项目储备，覆盖临床前到临床阶段新药品种9个，4个已进入临床。已与多家国外知名以及上市医药公司建立了长期的合作，包括与德国上市公司Wilex AG、4SC AG、Dr WOLFF等，通过专利药物的合作开发，建立战略性合作伙伴关系。目前已达成4项国际独占许可，2项国内企业独占权合作开发，完成多个合作项目的落地与转化。广州领晟组建了一支由经验丰富的博士后、博士、海归技术专家为核心的高层次、高效率的人才研发队伍。
作为一家发展快速的新技术企业，具有开拓精神的团队，优质的人才是我们领晟发展的动力和基石。我们欢迎有能力有激情，有致从事创新药物开发的您加入。公司网站：***************************/