医学部专员(MA)
北京领初医药科技有限公司
- 公司规模:50-150人
- 公司性质:民营公司
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2019-04-12
- 工作地点:北京
- 招聘人数:5人
- 工作经验:1年经验
- 学历要求:硕士
- 职位月薪:15-20万/年
- 职位类别:临床研究员
职位描述
* Prepare integrated clinical trial report both in English and Chinese in collaboration with project team members, based on results from clinical trials according to GCP, SOPs, and external guidelines.
* Prepare abstracts, posters, slide presentations, and publications in collaboration with investigators, marketing, and clinical team members based on results from clinical trials.
* Give professional input to publications prepared by doctors.
* Provides information collection, literature retrieval and the corresponding support for clinical studies and the submission of registration documents
* Provides relevant literature retrieval for products, the progress of clinical studies and other information
* Reports adverse drug events in accordance with national regulations and internal establishments, including the medicine both under clinical research and post marketing.
* To maintain the Office Library.
* To maintain the SOP.
* Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas
岗位要求:
* Bachelor's degree or above in Medical science.
* Fluent English on both written & verbal.
* 2 years of experience in clinical is prefer.
* Ability to accurately and clearly present clinical data as well as strong verbal and written
* Good communication skills and teamwork spirit
* Ability to work independently, to handle multiple tasks simultaneously.
* Previous working experience in pharmacovigilance.
职能类别: 临床研究员
公司介绍
? 非临床向临床过渡阶段:预测人体PK/PD特征,撰写新药临床开发整体策略书、撰写FIH临床研究方案;
? 早期临床开发阶段:新药临床开发整体策略书更新;创新药开发决策支持(GO/No-Go);临床试验方案设计及报告撰写(SAD/MAD;BA/BE/FE;特殊人群试验;DDI);定量药理学研究(包括群体药动学/药效学(PK/PD)、基于生理的PK研究(PBPK)、基于模型的荟萃分析(MBMA)等建模与模拟服务);提供高水平Phase I 研究平台(临床试验组织及执行);数据管理及统计分析;新药(包括小分子和大分子药物)及生物标记物检测分析;
? 晚期临床开发阶段:新药临床开发整体策略书更新;创新药开发决策支持(GO/No-Go);临床试验方案中临床药理学研究部分的设计支持及相应报告撰写(群体PK/PD研究;剂量确定);定量药理学研究(包括群体药动学/药效学(PK/PD)、基于生理的PK研究(PBPK)、基于模型的荟萃分析(MBMA)等建模与模拟服务);
? 注册阶段:帮助申办者整理新药整体临床研究总结报告(包括临床药理学部分);注册咨询;
? 培训服务:对I期临床试验机构和制药企业提供临床药理学培训服务
现公司因发展需要诚聘以下职位,欢迎广大优秀人才加入,请有意者发简历至HR-LTT@LTT-BJ.COM,除常规可匹配外企的福利、待遇以外,公司将为各位优秀人才提供良好的职业发展空间、高质量培训机会以及参与/领导我国创新药(如PD1、ADC等1类重磅创新药)早期临床开发的项目研究机会。
联系方式
- Email:HR-LTT@LTT-BJ.COM
- 公司地址:地址:span海淀区车公庄西路19号华通大厦