文件控制与培训经理
Manager, Document Control and Training
关于Jade Biosciences
Jade Biosciences是一家处于临床阶段的生物技术公司，专注于开发最佳疗法，以解决自身免疫疾病中的关键未满足需求。Jade的候选药物JADE101针对细胞因子APRIL，目前正在针对免疫球蛋白A肾病进行I期临床试验。Jade的产品管线还包括JADE201，这是一种无岩藻糖的抗BAFF-R单克隆抗体，以及JADE301，一种尚未公布的抗体候选药物，两者目前均处于临床前开发阶段。Jade基于从Paragon Therapeutics获得的资产启动，Paragon Therapeutics是一家由Fairmount创立的抗体发现平台。如需更多信息，请访问 并关注LinkedIn上的公司页面。
职位概述
文档控制与培训经理将支持端到端的文档管理和培训流程。该职位将支持日常管理与文档管理和培训系统的行政工作。
主要职责
- 支持完整的文档生命周期，包括创建、审查、批准、分发、修订、归档和作废。
- 确保受控文档符合所有内部要求，包括受控文档的格式。
- 传递文档以供签署，并确保满足相关要求。
- 建立并维护与岗位职能一致的培训矩阵/课程。
- 创建并管理培训和文档管理指标。
- 推动培训有效性的持续改进（包括入职培训、定期培训和检查准备），以及文档管理流程。
- 确保培训记录准确且可审计追溯。
- 在数据评审中代表文档控制与培训部门，包括管理评审，按要求突出趋势、风险和改进机会。
- 确保文档正确组织、存储，并可供授权人员访问。
- 维护准确的日志和档案。
- 监督文档版本控制并支持报告生成。
- 支持文档管理和培训系统的流程和/或系统变更。
- 与跨职能团队协作并跟进，收集和审查文档需求，提供系统/流程特定的支持，并收集和审查改进领域。
资格要求
- 本科及以上学历，5-8年以上制药/生物技术研发经验，包括3-5年以上文档控制或相关领域的经验。
查看英文原文
About Jade Biosciences
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit and follow the Company on LinkedIn.
Role Overview
The Manager, Document Control and Training will support the end-to-end Document Management and Training processes. This role will support various functions within the day-to-day management and administration of the document management and training system.
Key Responsibilities
- Support the full document lifecycle including creation, review, approval, distribution, revision, archival, and obsolescence.
- Ensure controlled documentation complies with all required internal requirements including formatting of controlled documents.
- Route documents for signature and ensure requirements are met.
- Establish and maintain training matrices/curricula aligned to job functions.
- Create and manage training and document management metrices.
- Drive continuous improvement in training effectiveness (including onboarding, recurring training, and inspection preparedness) and document management processes.
- Ensure accurate training records and audit-ready traceability.
- Represent Document Control and Training at data reviews, including Management Review, highlighting trends, risks and improvement opportunities as requested.
- Ensure that documents are properly organized, stored, and accessible to authorized personnel.
- Maintain accurate logs and archives.
- Oversee document version control and support report generation.
- Support process and/or system related changes to the document management and training systems.
- Collaborate and follow up with cross-functional teams to gather and review documentation requirements, provide system/process specific support and gather and review areas of improvement.
Qualifications
- Bachelor’s degree and 5-8+ years of pharmaceutical/biotech R&D experience, including 3-5+ years of experience in Document Control
- Experience administering training and documentation in Veeva Basics is a must
- Strong administrative and organizational skills
- Proficient in file and electronic data management systems
- Excellent technical writing skills
- Knowledge of records management principles and practices
- Familiarity with document management software
- Proficiency in using SharePoint and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).
Position Location
This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is $130,000 - $140,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.
As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.
Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Originally posted on Himalayas