法律专员(波兰)
Legal Specialist (Poland)
Description
法律专员支持法务部为公司的临床研究运营提供高效、准确和及时的法律和行政协助。该职位在符合适用于临床研究活动的相关法律、法规和内部政策的前提下,参与合同管理、公司治理、监管合规支持和法律文件工作。
具体而言,法律专员需要:
- 协助准备、审查、协调和管理与临床研究相关的合同,包括但不限于:临床试验协议(CTAs)、保密披露协议(CDAs)、供应商和顾问协议、修订和合同附加条款
- 协调合同执行流程,包括跟踪签名、版本和审批情况
- 维护和更新合同数据库、跟踪表和文档管理系统
- 支持与临床试验相关的法律合规活动,包括审计、检查和尽职调查所需的文件
- 根据需要进行与医疗保健、临床研究、数据保护和公司法相关的法律和监管研究
- 提供隐私合规支持,完成并跟踪隐私评估、数据保护影响评估(DPIAs)和其他所需文件
- 协助法务部回应与合同、政策和法律流程相关的内部咨询
- 协助开发、更新和整理法律模板、标准操作程序(SOPs)、政策和培训材料
- 与内部利益相关者(临床运营、财务、采购、人力资源、质量等)沟通,确保及时准确的法律支持
- 在需要时与外部律师、公证人和监管机构协调
- 确保保密性、准确性,并遵守适用的法规(例如GCP、隐私法、合同义务)
Requirements
- 法律助理或同等法律培训的文凭或证书
- 3–5年法律助理或律师助理经验,最好在CRO、制药、生物科技或受监管环境中工作过
- 会考虑不同组合的相关教育和工作经验
- 对合同管理和法律文件有深入了解
- 熟悉临床研究运作、GCP和监管框架
- 优秀的组织能力
查看英文原文
Description
The Legal Specialist supports the Legal Department in providing efficient, accurate, and timely legal and administrative assistance related to the Company’s clinical research operations. The role contributes to contract management, corporate governance, regulatory compliance support, and legal documentation, in alignment with applicable laws, regulations, and internal policies governing clinical research activities.
More specifically, the legal specialist must:
- Assist in the preparation, review, coordination, and administration of contracts related to clinical research activities, including but not limited to: Clinical Trial Agreements (CTAs) , Confidential Disclosure Agreements (CDAs) , Vendor and consultant agreements , Amendments and contract addenda
- Coordinate contract execution workflows, including tracking signatures, versions, and approvals.
- Maintain and update contract databases, trackers, and document management systems.
- Support legal compliance activities related to clinical trials, including documentation required for audits, inspections, and due diligence processes.
- Conduct legal and regulatory research related to healthcare, clinical research, data protection, and corporate law as required.
- Privacy compliance support, completing and tracking privacy assessments, DPIAs, and other required documentation.
- Support the Legal Department in responding to internal inquiries related to contracts, policies, and legal processes.
- Assist in the development, updating, and organization of legal templates, SOPs, policies, and training materials.
- Liaise with internal stakeholders (Clinical Operations, Finance, Procurement, HR, Quality, etc.) to ensure timely and accurate legal support.
- Coordinate with external counsel, notaries, and regulatory bodies when required.
- Ensure confidentiality, accuracy, and compliance with applicable regulations (e.g., GCP, privacy laws, contractual obligations).
Requirements
- Diploma or certificate in Paralegal Studies or equivalent legal training.
- Minimum of 3–5 years of experience as a paralegal or legal assistant, preferably in a CRO, pharmaceutical, biotech, or regulated environment.
- Different combinations of relevant education and work experience will be considered
- Strong understanding of contract administration and legal documentation.
- Familiarity with clinical research operations, GCP, and regulatory frameworks.
- Excellent organizational skills with strong attention to detail.
- Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
- Strong written and verbal communication skills in English.
- High level of discretion and professionalism when handling confidential information.
- Proficiency with Microsoft Office and contract/document management systems.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Permanent full-time position
- Vacation, PPK, health allowance
- Home-based position with teleworking allowance
- Ongoing learning and development
Work location
This position is opened to candidates across Poland (home-based position).
Recruitment process: what to expect
- As part of the recruitment process for this position you will meet various team members at Indero
- The first interview will be conducted by phone (20 minutes) and the second via video conference (1 hour)
- The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Poland.
Originally posted on Himalayas