医学撰稿人（制药行业）
Medical Writer (Pharmaceutical)
职位名称：医学撰写人（制药行业）
职位类型：合同工
工作地点：远程
micro1 正在招募医学撰写人/临床文档作者，参与一个客户项目，专注于开发先进的AI辅助写作工具用于临床文档。在此职位中，您将运用专业知识帮助训练下一代AI系统。您的工作将影响模型如何通过高质量的现实输入进行学习、推理和执行。无需AI相关经验——您的专业领域知识才是关键。
工作范围
- 根据临床研究报告、DSUR、PSUR/PBRER及相关的临床文档，撰写和审核真实的评估任务，以指导AI工具的开发。
- 运用专业判断评估AI生成的内容是否符合临床模板和结构要求，包括ICH E3的组织结构、章节顺序、交叉引用和附录管理。
- 评估叙述部分的科学准确性，如疗效、安全性摘要、讨论和结论，区分真正的科学或解释性错误与风格差异。
- 追踪叙述性主张的来源记录—表格、图表、列表和方案—以验证所有断言是否得到适当支持。
- 为每次评估提供清晰且结构化的书面理由，以便精确诊断和改进AI模型行为。
- 与项目负责人合作，完善评估框架，并在AI背景下记录临床法规撰写的最佳实践。
优先资格
- 在申办方、CRO或作为独立顾问，至少5年的法规医学撰写经验。
- 独立撰写或领导撰写完整临床研究报告的经验，而非摘要或部分贡献。
- 熟悉ICH E3以及定期安全报告（ICH E2F、ICH E2C）的规范和eCTD放置。
- 能够阅读和解读TFL和方案文件，识别叙述内容与源数据之间的差异。
- 出色的书面和口头沟通能力，特别是在提供结构化、可操作的临床内容反馈方面。
- 生命科学、药学或医学领域的高级学位（博士、药学博士、医学博士、硕士），或同等深度的撰写经验。
- 具有多项临床阶段和治疗领域的经验；尤其重视肿瘤学和血液学的专业知识。
- 加入我们客户的团队
查看英文原文
Role Title: Medical Writer (Pharmaceutical)
Role Type: Contractor
Location: Remote
micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.
Scope of Work
- Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
- Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
- Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
- Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
- Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
- Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.
Preferred Qualifications
- Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
- Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
- Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
- Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
- Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
- Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
- Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.
Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.
Originally posted on Himalayas