Medical Writer 医学撰写

Medical Writer 医学撰写 Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies . With over 25 years of experience and a world-renowned focus in renal research , Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role Researches, writes, and edits clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, sections of regulatory submission documents, and scientific manuscripts by applying therapeutic expertise and clinical drug development knowledge and relevant experience to the development of drugs, biologics, devices and or other products for human use. May provide writing support for more complex clinical documentation, with appropriate departmental supervision. 研究、撰写和编辑临床文档，包括临床研究报告、临床研究方案、临床计划大纲、监管申报文件的相关章节以及科学手稿。通过运用治疗领域专业知识、临床药物开发知识及相关经验，支持用于人体的药物、生物制品、医疗器械和/或其他产品的开发。在适当的部门监督下，可为更复杂的临床文档提供写作支持。 Responsibilities Independently writes, reviews, and edits routine documents (e.g., protocols, CSRs, IBs, scientific manuscripts). Independently interprets non-clinical and clinical data in preparing technical reports. Independently performs literature searches and reviews. Participates in project teams, coordinating report specifications and data analysis. Schedules and conducts peer and team quality control reviews for assigned projects. Reviews relevant documents and interacts with functional leader and project manager to understand project timelines. Performs other tasks as directed by line manager. 独立撰写、审阅和编辑常规文档（如方案、CSR、研究者手册、科学手稿等）。 独立解读非临床和临床数据，准备技术报告。 独立执行文献检索与综述。 参与项目团队，协调报告规范起草和数据分析。 安排并执行指定项目的同行及团队质量控制审查。 审阅相关文档，与职能负责人和项目经理沟通，了解项目时间表。 根据直属经理的指示执行其他任务。 Job Factors (Knowledge, Skills and Abilities) 胜任力要求（知识、技能和能力） Knowledge: Solid background in clinical medicine or pharmaceutical sciences; familiar with ICH-GCP and key NMPA/FDA requirements; knowledge of full clinical trial process and basic statistical principles. Skills: Independently drafts moderately complex documents (protocols, CSR drafts, IB); good data interpretation skills; proficient in English and Chinese (reading and writing). Abilities: Good cross-functional communication skills; ability to manage timelines for 1–2 projects; problem-solving awareness. 知识：扎实的临床医学/药学背景；熟悉ICH-GCP及NMPA/FDA核心要求；熟悉临床试验全流程及基础统计原理。 技能：独立撰写中等复杂度文档（方案、CSR初稿、研究者手册）；具备良好数据解读能力；中英文读写熟练。 能力：良好的跨部门沟通能力；能够管理1-2个项目的时间节点；具备问题解决意识。 About You Bachelor's/Master's degree from an accredited institution in Life Sciences or Health-related Sciences. 2-4 years of science or medical related writing experience. Familiar with common medical terminology and clinical research terminology. Proficient in PC-Windows and MS Word; familiar with basic document templates. Excellent written, oral communication and presentation skills; able to participate in project team communications. Fluent in English reading, writing, and speaking; able to independently draft English documents. 1-3 years of experience in pharmaceutical company or CRO developing drugs for human use (e.g., medical writing, clinical trial management). Basic experience in clinical study design and protocol development/writing (participated in protocol drafting). Basic knowledge of regulatory submission requirements and ICH CSR writing guidelines. 持有经认可机构颁发的生命科学或健康相关科学领域的本科/硕士学位。 具备2-4年科学或医学相关写作经验。 熟悉常用医学术语及临床研究相关术语。 熟练使用PC端Windows操作系统及MS Word，熟悉基础文档模板。 具备优秀的书面、口头沟通及演示能力，能够参与项目组沟通。 英语读写说流利，能够独立撰写英文文档，与国外客户或同事进行英文沟通。 具有临床研究设计及方案制定/撰写的基础经验（参与过方案撰写）。 了解监管申报要求及ICH临床研究报告撰写指南的基本内容。 Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work : You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise : Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience. • Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates. Department Medical Writing Role Medical Writer Locations Multiple locations Remote status Fully Remote Employment type Full-time Applicant tracking system by Teamtailor