医学撰写员
Medical Writer
在Clario，Thermo Fisher Scientific旗下部门，我们的使命是通过解锁更好的证据来改变生命。通过我们的数字生理解决方案，我们帮助制药、生物技术和医疗设备公司生成评估新疗法安全性和有效性的数据。
作为全球心脏解决方案团队中的一名医学撰稿人，你将在临床试验结果和科学证据的沟通中发挥关键作用。你将与统计学家、科学家和心脏安全专家紧密合作，撰写高质量的专家报告、统计分析计划和其他临床研究文档，以支持监管提交和关键开发决策。这是一个为经验丰富的科学撰稿人提供的令人兴奋的机会，你将享受将复杂的临床和统计数据转化为清晰、准确且具有说服力的科学成果，并为改变生命的疗法开发做出贡献。
我们提供
- 竞争性的薪酬和激励计划
- 私人医疗、养老金和人寿保险
- 支持工作与生活平衡的灵活工作安排
- 丰厚的年假和健康促进计划
- 在全球组织中的职业发展机会
- 接触协作的全球团队和创新技术
- 参与改善全球患者预后的研究的机会
你将负责
- 基于统计结果、研究发现和科学结论，撰写、编辑、校对并最终定稿高质量的专家报告。
- 与统计和科学团队合作，制定和维护心脏安全研究的统计分析计划（SAP）。
- 确保所有书面交付物科学准确、表达清晰，并符合监管要求。
- 与内部利益相关者合作，解读研究数据，并向客户有效传达结果。
- 在多个研究中管理文档的时间表和优先级，同时保持卓越的质量标准。
- 按需支持其他科学和临床研究文档的准备。
- 为科学和医学撰稿活动中的流程改进和最佳实践做出贡献。
- 参与客户互动和科学讨论，以支持项目的成功交付。
- 与统计和科学团队合作，支持客户在研究综述开发中的工作
查看英文原文
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. Through our Digital Physiology solutions, we help pharmaceutical, biotechnology and medical device companies generate the data needed to assess the safety and effectiveness of new therapies.
As a Medical Writer within our Global Cardiac Solutions team, you will play a critical role in the communication of clinical trial results and scientific evidence. Working closely with statisticians, scientists and cardiac safety experts, you will develop high-quality expert reports, statistical analysis plans and other clinical study documentation that supports regulatory submissions and critical development decisions. This is an exciting opportunity for an experienced scientific writer who enjoys translating complex clinical and statistical data into clear, accurate and compelling scientific deliverables that contribute to the development of life-changing therapies.
What We Offer
- Competitive compensation and incentive programmes
- Private healthcare, pension and life assurance
- Flexible working arrangements supporting work-life balance
- Generous annual leave and wellbeing initiatives
- Opportunities for professional growth within a global organisation
- Access to collaborative global teams and innovative technologies
- The opportunity to contribute to research that improves patient outcomes worldwide
What You'll Be Doing
- Author, edit, proofread and finalise high-quality Expert Reports based on statistical outputs, study findings and scientific conclusions.
- Partner with Statistical and Scientific teams to develop and maintain Statistical Analysis Plans (SAPs) for cardiac safety studies.
- Ensure all written deliverables are scientifically accurate, clearly communicated and aligned with regulatory expectations.
- Collaborate with internal stakeholders to interpret study data and effectively communicate results to sponsors.
- Manage document timelines and priorities across multiple studies while maintaining exceptional quality standards.
- Support the preparation of additional scientific and clinical study documentation as required.
- Contribute to process improvements and best practices within scientific and medical writing activities.
- Participate in client interactions and scientific discussions to support successful project delivery.
- Partner with Statistical and Scientific teams to support sponsors in the development of study synopses, protocols and other clinical research documents related to cardiac safety.
- Coordinate the timely delivery of Expert Reports, Statistical Analysis Plans and other key study outputs.
- Maintain a strong understanding of FDA, EMA, ICH and other relevant regulatory guidance related to clinical trial reporting and documentation.
- Stay current with developments in clinical research, cardiac safety assessment and scientific communication.
- Support cross-functional initiatives within the broader Digital Physiology business.
What We Look For
- Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Healthcare, or a related scientific discipline. Advanced degree (MSc, PhD or PharmD) preferred.
- Minimum 5 years' experience in medical, scientific or clinical writing within the pharmaceutical, biotechnology, CRO or clinical research sectors.
- Experience authoring scientific reports, statistical analysis plans, clinical study documentation and regulatory deliverables.
- Previous experience supporting Cardiology, Cardiac Safety, ECG analysis, electrophysiology or cardiovascular clinical trials is required.
- Strong understanding of clinical trials, ICH guidelines, and FDA and EMA regulatory requirements.
- Proven ability to interpret and communicate complex clinical and statistical data.
- Excellent written communication skills, attention to detail and document quality standards.
- Strong organisational and project management skills, with the ability to manage multiple priorities and deadlines.
- Experience collaborating with cross-functional teams, including statisticians, physicians and scientific experts.
- Proficient in Microsoft Office applications, particularly Word.
- Able to work independently and effectively within a fast-paced global environment.
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It's a cause that unites and inspires us. It's why we come to work—and how we empower our people to make a positive impact every day.
Whether you're advancing clinical science, developing innovative technology, or supporting our customers around the world, your work helps bring life-changing therapies to patients faster.
Originally posted on Himalayas