高级医学撰稿人/资深医学撰稿人
Senior Medical Writer/Principal Medical Writer
职位概述：
高级医学撰稿人/资深医学撰稿人将负责领导高质量且按时完成的临床研究文件的开发。具体职责包括临床文件规划、撰写、编辑/排版以及执行质量检查。根据 Precision MW 风格指南、Precision 标准操作程序（SOP）、适用的监管指南（如 ICH、FDA、GCP）和 eCTD 要求来编写文件。成功候选人应清楚了解基于监管要求的所有开发阶段的关键临床文件的内容要求，并以极高的细致程度完成医学撰稿相关工作。
该职位的核心职责包括但不限于：
- 规划、撰写、编辑、排版及质量检查及时且高质量的临床文件，包括临床研究方案、研究者手册（IB）、知情同意书（ICF）模板、DSUR、CSR、CSR 患者叙述，具备基于监管指南的内容要求的清晰理解
- 与发起方、外部供应商和/或内部 Precision 项目团队/部门协作，确保从模板到最终批准版本的文档管理顺畅且高效
- 能够独立从临床研究数据中提炼关键信息
- 能够运用知识和技能，理解流程，撰写复杂内容
- 能够清晰简洁地与内部团队和客户团队进行书面和口头沟通
- 参与医学撰稿流程、SOP、模板和工作指导文件的开发与维护
- 优秀的解决问题能力
- 进行基于文献的研究以支持撰稿工作
- 其他指派的任务
资格要求：
最低要求：
- 科学或医学领域的学士学位或同等学历，并具备相关的写作经验
- 在发起方和/或 CRO 环境中担任高级医学撰稿人5年以上，或担任资深医学撰稿人7年以上
其他要求：
- 熟练使用 Microsoft Windows、Teams、Word、Excel、Adobe Acrobat 和 PowerPoint
- 清楚了解适用的法规（如 ICH、FDA、GCP）、临床试验透明性要求（如 EudraCT、CT.gov）以及所有开发阶段的 eCTD 要求
- 极高的细致程度，能够按时完成撰稿任务
- 能够在快速变化的环境中有效工作
查看英文原文
Position Summary:
The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.
Essential functions of the job include but are not limited to:
- Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidance's
- Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
- Ability to independently formulate key messages from clinical study data
- Ability to author complex content using knowledge/skills and understanding of processes
- Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
- Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
- Excellent problem-solving skills
- Performing literature-based research to support writing activities
- Other duties as assigned
Qualifications:
Minimum Required:
- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5+ years of experience as a Sr. Medical Writer in the sponsor and/or CRO setting or 7+ years of experience as a Principal Medical Writer.
Other Required:
- Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
- Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development
- Impeccable attention to detail and ability to complete writing assignments in a timely manner
- Ability to work effectively in a fast-paced environment with multiple high-priority projects with no instruction on routine work and minimal instruction on new assignments
Preferred:
- Advanced degree (MS/PhD)
- Oncology and/or rare disease experience (especially protocol and CSR development)
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