Senior Medical Writer – Client Aligned (FSP)
职位标题：高级医疗作家 客户配合 (FSP) 工作地点：远程，英国的工作地点类型：远程工作合同类型：全日制工作资深级别：环境条件：办公室工作时间表：标准 （月-周五）工作时间表标准 （月 -周五）環境条件办公室职位描述 在 Thermo Fisher Scientific,你将发现有意义的工作在全球范围内产生积极影响。加入我们的同事来实现我们的使命 - 使我们的客户能够使世界更健康，更清洁和更安全。我们为团队提供实现个人职业目标所需的资源，同时通过研究，开发和交付改变生活治疗将科学进一步发展。在100多个国家进行的临床试验以及通过我们的 PPD 临床研究组合不断开发新的临床研究框架，我们的工作涵盖了实验室，数字和分散的临床测试服务。你提供质量和准确性的决心将改善人们和社区现在和未来依赖的健康结果。总结目的：我们很高兴扩大欧洲的医学写作 FSP 团队。我们正在寻找一个专注于客户的 MSW 在 FSP 领域；经验结构化内容编写系统和自动化支持交付将优先。我们正在寻求一名有才华和经验丰富的高级医学作家加入我们的团队。高级医学作者将负责开发高质量的临床和监管文件，确保它们符合所有监管要求和公司标准。关键责任：·撰写和编辑临床和规范文档，包括临床研究报告，协议，调查人员小册子和监管提交。·与跨职业团队合作，收集必要的信息并确保文件的准确性和完整性。· 确保文件符合监管指南，公司标准和行业最佳实践。·提供有关文档内容，结构和演示的输入。·审查和反其他团队成员编制的文件。·管理分配项目时间表和成果。· 辅导和监督初级医学作家，确保高质量成果。· 与行业趋势，指南和监管要求保持最新状态。教育和经验：· 学士学位在科学领域
查看英文原文
Job Title: Senior Medical Writer – Client Aligned (FSP)
Job Location: Remote, United Kingdom
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Environmental Conditions: Office
Work Schedule: Standard (Mon-Fri)
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
We are excited to be expanding our Medical Writing FSP Team in Europe. We are looking for a SMW to be dedicated to a client in the FSP space; experience in Structured Content Authoring systems and automation to support delivery would be preferred. We are seeking a talented and experienced Senior Medical Writer to join our team. The Senior Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards.
Key Responsibilities:
- Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
- Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.
- Ensure documents align with regulatory guidelines, company standards, and industry best practices.
- Provide input on document content, structure, and presentation.
- Review and provide feedback on documents prepared by other team members.
- Manage timelines and deliverables for assigned projects.
- Mentor and provide oversight to junior medical writers and ensure high-quality deliverables
- Stay current with industry trends, guidelines, and regulatory requirements.
Education and Experience:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.
- Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 5+ years).
- Experience working in the pharmaceutical/CRO industry required.
- Experience in managing and directing complex medical writing projects required.
- EU CTR experience preferred.
Knowledge, Skills, and Abilities:
- Excellent organizational and program management skills.
- Proven leadership skills to manage and mentor a team of medical writers.
- Extensive knowledge of regulatory guidelines and drug development processes.
- Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders.
- Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards.
- Self-motivated and adaptable.
- Excellent judgment; high degree of independence in decision making and problem solving.
- Why Join Us?
- When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas