Quanticate
Document Specialist (Consultant)
IN · India · Remote · Contract · Mid
Salary not stated
AI summary
About the company
Quanticate是全球领先的以数据为核心的CRO，服务全球顶尖制药公司及小型生物科技公司，聚焦复杂临床试验的数据相关服务。
Role overview
该岗位为合同制远程岗位，隶属于全球领先的CRO公司Quanticate，负责临床与监管文档的格式排版、发布、质量控制及披露相关的编辑工作，需与多跨职能团队协作，确保文档符合监管要求与质量标准，支持全球临床试验相关提交工作。
Responsibilities
- 编译、排版、发布符合ICH E3要求的临床研究报告及附录
- 准备带书签、超链接等功能的提交就绪PDF文档
- 处理全球提交所需的各类临床与监管文档
- 开展文档级质量控制，确保格式、内容等合规准确
- 对临床与监管文档进行编辑以满足披露要求
- 支持电子文档包准备及文档全生命周期管理
- 与多团队协作解决文档相关问题
- 参与流程改进，保持对监管指南的了解
Requirements
- 生命科学、药学等相关专业学士学位
- 3年以上制药、生物科技或CRO环境的相关经验
- 具备编译发布临床研究报告及附录的实操经验
- 熟练使用Adobe Acrobat及文档发布软件
- 具备文档质量控制及编辑的相关经验
- 精通Microsoft Word、Adobe Acrobat等工具
- 了解临床与监管文档标准及GCP要求
- 具备优秀的沟通能力及细节把控能力
Pay & benefits
- 有竞争力的薪资
- 灵活的工作时间
- 多种假期（年假、病假等）
- 本人及直系家属的医疗保险
- 退休金（Gratuity）
- 意外保险及学习发展机会
Hiring process & how to apply
- 招聘基于 merit，无付费要求
- 合法沟通来自Quanticate指定域名
- 可在官网查看招聘流程及求职安全指南
Notes for China-based candidates
- 岗位为远程合同制，面向全球候选人
- 结算相关信息未明确，需以雇主通知为准
- 需具备良好的英文沟通能力
- 需熟悉临床与监管文档相关要求
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Excerpt
Are you passionate about delivering high-quality clinical and regulatory documents that support global submissions and clinical trial transparency? We are looking for a Document Specialist (Consultant) to join our team and play a key role in the formatting, publishing, quality control, and…
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