河源招聘

生物技术，临床医学，写作，中英互译，医学写作

Job Summary职位概述:

The Medical Writer oversees delivery/provides input/review of key clinical documents for regulatory submission and other documents not limited to below:

The primary focus of the Medical Writer will be on the generation of medical regulatory/scientific content and on the high quality, properly formatted and timely delivery of selected high priority Clinical Study Documents and relevant MRA medical writer’s communications. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/or international requirements and/or best practices.

The Medical Writer will be working closely with relevant stakeholders/SMEs that share the responsibilities for generating, changing and/or updating medical regulatory content. S/He also serve as the primary contact point for most of the documents.

（资深）医学撰写专员主导注册用重要临床文件的准备、审阅并为文件提供内容输入。文件类型包括但不限于:

（资深）医学撰写专员的主要工作重点是为特定的高优先级临床试验文件提供医学注册/科学内容，并为这些文件的高质量、格式规范和及时交付负责；同时也负责MRA医学撰写有关的交流工作。成功完成文件需要灵活的时间表管理，协调跨部门会议，与各职能部门专家（提供内容的专家）高效及时沟通，解决修改意见，注重细节和质量，严格遵守公司SOP、政策、指令、集团子公司标准、赫尔辛基宣言、业界标准、有关质量管理规范、以及中国监管部门/国际准则/***操作。医学撰写团队将同各利益相关方/SME紧密合作，分担医学注册文件的准备、修改和更新。她/他也将承担大多数文件的主要联络人工作。