研究启动与法规事务专员（2年以上经验）
Study Start Up and Regulatory Affairs Specialist (2 years plus experience)
医学在这里不断前进，你也将如此。
Ergomed 是一家专注于罕见病和特定肿瘤适应症的临床研究组织。我们专注于最复杂的试验，这些研究中，经验、判断力和严谨的运营责任能带来最大的影响。我们与中小型生物技术公司合作，推动有前景的疗法进入早期开发阶段，使它们更快地到达患者手中。
我们有意选择复杂的工作。罕见病和肿瘤试验具有真正的运营风险，而我们的员工是降低这种风险的专家，在保护时间表、数据质量和站点及患者的体验的同时，做到这一点。这是一项要求高且有意义的工作，这里没有人会忘记患者不能等待。
这就是为什么文化对我们而言和能力一样重要。我们建立了一个协作、国际化的团队，人们分享想法，提升职业发展，并被信任在早期承担职责。我们的同事遍布北美、南美、欧洲、亚洲和澳大利亚，我们重视团队合作、灵活性和对工作与生活平衡的真实承诺，因为优秀的科学来自感到被支持的人们。
如果你希望有目标地工作，拥有实现影响的敏捷性，并加入一个既关心工作本身也关心背后的人的团队，我们很期待收到你的来信。
该职位负责并协调所有与实现站点启动准备相关的活动。该角色提供专业领域知识，确保监管合规性，并作为内部团队、客户和外部利益相关者之间的关键联络人
· 对于指定范围内的研究启动和监管里程碑的交付负责。
· 在指定范围内就监管流程和文件方法独立做出决策。
· 处理中等复杂度的监管环境，包括适用的多国要求。
· 领导指定国家或中等复杂度项目的研发启动和监管活动，确保按时、符合质量标准和监管要求地完成。
· 领导监管和研究启动文件的准备、审查和质量控制（包括提交、必备文件和翻译），以确保完整性和准确性，并符合 ICH-GCP 和国家特定要求。
· 负责起草、协商、最终确定和执行…
查看英文原文
Medicine moves forward here. So will you.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.
We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.
That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.
If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.
The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related
to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory
compliance, and serves as a key liaison between internal teams, clients, and external stakeholders
· Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
· Make independent decisions within assigned scope regarding regulatory processes and documentation approaches.
· Handles medium-complexity regulatory environments, including multi-country requirements where applicable.
· Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
· Leads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
· Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines
· Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements.
· Contribute towards the preparation and/or review of complex technical/scientific/legal documentation.
· Arrange for and/or review translation of essential documents as required
· Provide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures and core documents
· Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables; support corrective/preventive actions
· Performs other work-related duties as assigned.
- Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
- Minimum 2 years within pharmaceutical or CRO industry or Regulatory body
- Good knowledge of ICH GCP and national regulations for territories of competency
- Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
· Quality: we hold ourselves to the standard patients deserve.
· Integrity and trust: we do the right thing, especially when it is hard.
· Drive and passion: we care about the outcome, because someone is waiting on it.
· Agility and responsiveness: we move quickly, because patients cannot wait.
· Belonging: everyone is welcome, and every voice counts.
· Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.