职位描述
Regulatory and Clinical Trial Support: advise on legal and regulatory compliance for clinical trials, FDA requirements, and drug development activities.
Corporate Governance: oversee corporate governance, entity compliance, and board material preparation, support corporate structure management and related transactions.
Contract Management: negotiate, draft, and manage a variety of agreements, including collaboration, service contracts, supply agreements, clinical trial and R&D related agreements.
Employment Law: advise on U.S. employment law, policies, and internal investigations, partner with HR to manage employee relations and compliance.
Risk & Compliance: identify and mitigate risks related to healthcare regulations, FCPA, IP and date privacy, support compliance with U.S. and global regulatory frameworks.
Cross-Functional Collaboration: collaborate with internal teams and external partners to align legal advice with business objectives, act as liaison with global legal teams and external counsel.
职位要求
uris Doctor (JD) degree from an accredited law school.
Admission to practice law in at least one U.S. jurisdiction.
Minimum of 8 years of legal experience, preferably in the biopharma or life sciences industry.
Proven experience advising on U.S. healthcare laws, FDA regulations, intellectual property, and privacy laws (e.g., HIPAA, CCPA).
Significant experience in drafting and negotiating business agreements, managing litigation, and advising on regulatory matters.
Strong interpersonal and communication skills, with the ability to work effectively with diverse teams and stakeholders.
Skills:
Leadership Potential: Demonstrated ability to lead complex projects and collaborate effectively across departments, showing potential for more senior leadership responsibilities.
Strategic Thinking: Strong business acumen with the ability to align legal strategies with company goals and anticipate future legal and regulatory challenges.
Problem Solving: Ability to assess legal risks, provide proactive solutions, and navigate complex legal landscapes in a fast-paced environment.
Contract Negotiation: Expertise in contract negotiation, drafting, and managing business agreements.
Communication: Excellent interpersonal and communication skills, with the ability to present legal concepts clearly to non-legal stakeholders and senior management.
Adaptability: Flexibility to manage a broad range of legal issues, from regulatory compliance to corporate governance and business transactions.
Team Collaboration: Proven track record of working collaboratively with internal teams, external counsel, and other stakeholders to achieve business goals.
