臨床標籤運營專員（100% 遠程）
Clinical Labeling Operations Specialist (100% Remote)
我们客户是生物技术和基因治疗领域的全球领先企业，现寻找一名临床标签操作专员（100%远程）。
工作时长：长期合同（可能延长）
薪资：$56.79/小时（W2）
公司福利：医疗、带薪病假、401K
临床标签操作专员负责在监管事务、质量保证、供应链、项目团队和包装站点全球范围内协调新临床标签及标签更新的实施。该职位确保标签内容准确地从源文件中转移、映射、审查并按照 FDA 要求、cGMP 标准和适用的监管指南进行实施。
主要职责
- 与监管事务、质量、供应链、项目经理和包装站点协调全球临床标签的实施。
- 在 Bartender 中创建并映射标签内容，开发业务连续性标签。
- 审查最终产品标签内容和映射，确保准确性和与源文件的一致性。
- 与监管事务合作获取批准文本，管理时间表，并确保满足要求。
- 领导运营卓越和流程改进项目。
- 编写和更新 SOP、指南和操作说明。
- 支持标签更新，并跨职能协作以实现部门目标。
所需资格
- 本科学历且有6年以上相关经验，或硕士学历且有4年以上相关经验。
- 药品或其他受监管行业的经验。
- 临床或商业供应链运营经验。
- 熟悉药品艺术设计和标签制作。
- 熟悉 FDA 法规、cGMP 标准和监管指南。
- 具备良好的项目协调、沟通、技术写作和人际交往能力。
- 熟练使用 Microsoft Office。
优先条件：有 Bartender 软件和标签内容映射经验。
如感兴趣，请将更新的简历发送给我们
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最初发布于喜马拉雅山
查看英文原文
Our client, a worldleader in biotechnology and gene therapy, is looking for anClinicalLabeling Operations Specialist (100% Remote).
Job Duration: LongTerm Contract (Possibility Of Extension)
Pay Rate : $56.79/hr onW2
Company Benefits:Medical, Paid Sickleave, 401K
The Labeling OperationsSpecialist coordinates the implementation of new clinical labeling and labelingupdates across Regulatory Affairs, Quality Assurance, Supply Chain, projectteams, and packaging sites worldwide. This role ensures label content is accuratelytransferred, mapped, reviewed, and implemented in accordance with sourcedocuments, FDA requirements, cGMP standards, and applicable regulatoryguidance.
Key Responsibilities
- Coordinate global clinical labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites.
- Create and map label content within Bartender and develop Business Continuity Labels.
- Review final product label content and mapping for accuracy and alignment with source documents.
- Partner with Regulatory Affairs to obtain approved text, manage timelines, and ensure requirements are met.
- Lead operational excellence and process improvement projects.
- Author and update SOPs, guidelines, and work instructions.
- Support labeling updates and collaborate cross-functionally to meet departmental objectives.
Required Qualifications
- Bachelor’s degree with 6+ years of relevant experience, or Master’s degree with 4+ years of relevant experience.
- Experience in the pharmaceutical or other regulated industry.
- Experience with clinical or commercial supply chain operations.
- Familiarity with pharmaceutical artwork and labeling production.
- Knowledge of FDA regulations, cGMP standards, and regulatory guidance.
- Strong project coordination, communication, technical writing, and interpersonal skills.
- Proficiency with Microsoft Office.
Preferred:Experience with Bartendersoftware and label content mapping.
If interested, pleasesend us your updated resume at
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Originally posted on Himalayas