高级医学撰写员 – 客户对齐（FSP）
Senior Medical Writer – Client Aligned (FSP)
职位名称：高级医学撰稿人 – 客户对齐（FSP）
工作地点：远程，英国
工作地点类型：远程
工作合同类型：全职
职位级别：
环境条件：办公室
工作时间：标准（周一至周五）
工作时间
标准（周一至周五）环境条件
办公室职位描述
在Thermo Fisher Scientific，您将从事具有深远意义的工作，在全球范围内产生积极影响。加入我们的同事，让我们的使命得以实现——帮助客户让世界更健康、更清洁、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、开发和交付改变生命的疗法，推动科学向前发展。我们已在100多个国家开展临床试验，并通过PPD临床研究组合持续开发新的临床研究框架，我们的工作涵盖实验室、数字和去中心化临床试验服务。您对质量和准确性的坚持将改善人们和社区所依赖的健康结果——现在和未来。
主要职责：
· 撰写和编辑临床和监管文件，包括临床研究报告、方案、研究者手册和监管提交文件。
- 与跨职能团队合作，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。
- 对文件内容、结构和呈现方式提出建议。
- 审核并为其他团队成员准备的文件提供反馈。
- 管理分配项目的进度和交付物。
- 指导和监督初级医学撰稿人，确保高质量的交付成果
- 跟踪行业趋势、指南和监管要求。
教育和经验：
· 科学相关专业的学士学位
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.
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Originally posted on Himalayas