医学撰写 - 北京市
22小时前
工作描述
工作职责核心撰写工作:
独立负责撰写、编辑和审核各类复杂的医学文件,包括但不限于:
临床开发阶段: 临床试验方案(Protocol)、研究者手册(IB)、临床研究报告(CSR)、知情同意书(ICF)。
注册申报阶段: 临床试验部分摘要(CTD模块2.5和2.7)、核心处方信息(SmPC)、药品特性概要(SmPC)。
学术交流阶段: manuscripts(用于同行评议期刊发表)、摘要、会议海报及口头报告。
医学信息与教育: 医学信息文档、医学问答(Q&A)、幻灯片库、疾病教育材料。
跨职能协作:
与临床、统计、注册、安全等团队紧密合作,收集、整合和分析科学数据,并将其转化为结构清晰、符合目标受众需求的文档。
组织和领导文档开发相关的会议,协调多方评审意见,确保项目按时高质量完成。
质量与合规:
确保所有输出文件严格遵守国际国内(如ICH-GCP、GPP3、公司SOP)的法规指南、行业标准和出版道德规范。
管理文档的版本控制、归档和审核追踪。
战略支持:
参与医学沟通策略的讨论,为数据呈现和医学信息传递提供专业见解。
跟踪最新的法规指南和行业最佳实践,并应用于日常工作。
任职要求
学历与专业:
硕士或博士学历,生命科学、医学、药学、生物学等相关专业背景。博士学历(PhD, MD, PharmD)优先考虑。
工作经验:
高级职位: 5年以上在制药企业、CRO或医学传播机构的医学撰写经验,具有全程主导CSR或CTD模块撰写经验者优先。
初级职位可适当放宽要求。
知识与技能:
卓越的写作能力: 具备出色的中英文书面表达能力,能精准、清晰、简洁地呈现复杂的科学数据。
深厚的科学素养: 具备强大的文献检索、批判性阅读和分析能力,能深入理解研究数据和临床意义。
法规知识: 熟悉ICH、GCP等药品注册法规和临床研究相关指南。
项目管理能力: 优秀的项目管理能力,能同时处理多项任务,严格遵守时间线。
软件技能: 精通Microsoft Office (Word, PowerPoint, Excel);熟悉EndNote、PubMed等文献管理工具和数据库。
任职要求
有较强策划能力、撰稿能力、执行力,能够根据业务需求制定相应媒体方案并实施。
3年以上工作经验,有大型医学新媒体工作经验优先。
有责任感,沟通能力强,思路清晰。
英语六级以上。
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