Provide legal counsel on clinical trials, data privacy, and data transfer matters.
Draft, review, and negotiate a wide range of R&D-related agreements, including:
Clinical trial agreements
Informed consent forms
Consultancy and service agreements
Investigator-initiated studies
Research collaborations and MTAs
Support academic collaborations and research consortiums.
Advise on regulatory compliance, transparency, pharmacovigilance, and inspection readiness.
Collaborate with internal legal, IP, compliance, and privacy teams to ensure alignment with applicable laws, regulations, and internal policies.
Contribute to continuous improvement of legal processes and templates.
Support other legal projects and initiatives as needed.
Advantage - experience interacting with U.S. clinical sites and applying legal guidance on FDA regulations related to clinical trials obligations and ensuring alignment with FDA expectations in global R&D activities.
Your experience and qualifications
Master of Law or equivalent European / International legal degree; bar admission required
3–8 years of relevant legal experience, ideally in a law firm, pharmaceutical company, or academic research setting
Solid understanding of legal and regulatory frameworks related to clinical research and drug development
Experience supporting U.S.-based clinical trials and regulatory related submissions is a strong advantage
Strong contract drafting and negotiation skills
Ability to assess complex legal issues and provide clear, actionable advice
Excellent communication and interpersonal skills with the ability to work effectively with stakeholders in different time zones, especially in the US
Team-oriented with a proactive, solution-focused mindset
Strong organizational skills and ability to manage multiple priorities in a fast-paced environment
High level of integrity, professionalism, and commitment to ethical conduct
Strong business acumen
Techniques to work effectively under pressure, meet deadlines, and adjust to changing priorities
Ability to think strategically and tackle complex problems
Ability to identify, advise on, minimize business risks, and propose practical solutions
Strong customer-orientation; an ability to see issues from the point of view of others
Ability to work successfully and cooperatively with colleagues across multiple cultures and time-zones
Substantive experience in Word, Excel, and PowerPoint
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