工作职责:
(a) Provide medical writing activities for all projects (e.g., reports, posters), providing full life-cycle support from clinical study protocols through regulatory dossier preparation and submission. Accountable for the quality, implementation and timeliness of medical writing deliverables across all therapeutic area (clinical evaluation reports, clinical study reports (phases 1 to 4), clinical study protocols, investigational drug brochures, Integrated Summaries of Efficacy and Safety, literature reviews, Background and Overview of Clinical Investigations). Ensure that clinical documents adhere to global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards.
参与所有医学项目的撰写(如报告,海报),给予临床试验从方案设计到监管档案的准备和提交的全程支持。负责将各治疗领域医学报告高质量,可行性和按时的完成(包括临床评估报告,临床试验报告(I到IV期),临床试验方案,研究药物手册,安全性和有效性总结报告,文献综述,背景和既往临床研究的回顾)。保证所有的临床文件严格按照国际标准,FDA,ICH和GCP指南并且符合电子刊物的出版规定。
(b) Develop slide decks; must have proficient top notch PowerPoint (PPT) skills; ability to develop slide decks with both high-quality scientific content and aesthetic design.
幻灯片的制作;必须有熟练的制作幻灯片技能;能够制作在内容和设计上都具有高质量的幻灯片。
(c) Performs other duties as required.
履行其他必要的职责。
任职资格:
1、医药等相关专业(生物,药学,生化,医学等)硕士学历,英语流利,有海外背景;
2、至少有3年的相关工作经历/培训经历;其中至少有一年从事医学及医学相关法规方面的撰写工作;
工作地点:在家或当地办公室
职位福利:14薪、五险一金、绩效奖金、餐补、通讯补助、补充医疗保险、定期体检、高温补贴