锦鲤求职岗位描述
岗位职责
1.文档撰写：撰写和编辑临床试验相关文档，包括研究方案、临床研究报告（CSR）、知情同意书（ICF）和患者信息手册等。Document Writing: Write edit clinical trial-related documents, including study protocols, clinical study reports （CSR）, informed consent forms （lCF）, patient information leaflets
2.法规遵从：确保所有文档符合国际和当地的法规要求，如ICH-GCP、FDA和EMA指南.Regulatory Compliance: Ensure all documents comply with international local regulatory requirements, such as lCH-GCP, FDA, EMA guidelines.
3.数据解读：分析和解读临床数据，将其转化为清晰、准确的科学文档。Data Interpretation: Analyze interpret clinical data, translating it clearly accurate scientific documents.
4.跨部门合作：与临床解决方案、项目管理和其他相关部门紧密合作，确保文档的准确性和及时性。Cross-functional
Collaboration: Collaborate closely with clinical solutions, project management, regulatory affairs, and other relevant departments to ensure the accuracy timeliness of documents.
5.质量控制：进行文档的质量控制检查，确保所有文档在提交前达到高质量标准。Quality Control: Conduct quality
control checks on documents to ensure all documents meet high-quality standards before submission.
6.版本管理：管理文档的版本控制，确保所有修订和更新都得到适当记录和批准。Version Control: Manage version
control of documents, ensuring all revisions updates are properly documented and approved.
7.支持上级分配的其它工作内容。Support other tasks assigned by superiors.
岗位要求
1. 硕士或博士学位，生命科学、药学、医学或相关领域。Masters Ph. D. Degree in Life Sciences, Pharmacy,
Medicine, related fields.
2.有血液科医生经验和药企工作经验。Experience as a hematologist and in the pharmaceutical industry
3.熟悉临床试验流程和相关法规要求。Familiar with clinical trial processes relevant regulatory requirements.
4.对医学写作的工作任务充满兴趣。Have a strong interest in the tasks of medical writing.
5.负责撰写和编辑各种医学和科学文档，确保内容的准确性、清晰性和符合法规要求。This role will be responsible for writing editing various medical scientific documents, ensuring accuracy, clarity, and compliance with regulatory
requirements.
6.具备相关的学术背景、出色的写作能力和对细节的关注。This role should have a strong related education
background, excellent writing skills, attention to detail.