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Job Function:
Legal & Compliance
Job Sub Function:
Law Business Partners
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
Senior Legal Counsel, R&D Legal EMEAContract: Full Time - Hybrid
Location: UK, High Wycombe
Role SummaryThis professional must have at least 7 years of legal experience, with a minimum of 5 years supporting R&D or clinical development or life sciences or healthcare industry.
The Senior Legal Counsel, R&D Legal EMEA will provide regional legal guidance and strategic legal support for clinical development-related activities for Johnson & Johnson’s Innovative Medicine Research & Development organization in Europe, the Middle East and Africa. This role will serve as a trusted legal advisor to business and functional partners on regional and cross-regional clinical development matters, including early- and late-stage clinical trials, investigator-initiated studies, collaborative research, external research activities, and other initiatives supporting the R&D portfolio.
The role will focus on providing practical, risk-based legal guidance; supporting program and portfolio reviews; identifying, assessing and helping mitigate legal and compliance risks; and enabling well-informed, compliant decision-making across the R&D organization. The Senior Legal Counsel will also provide legal oversight, drafting, and legal negotiation support for clinical research-related agreements and related documentation, including contract drafting, review, negotiation support, and timely escalation of complex or sensitive legal issues.
Key ResponsibilitiesThe Senior Legal Counsel will be responsible for providing strategic, pragmatic, business-oriented and timely legal guidance on complex clinical development-related matters in EMEA. Key responsibilities include:
- Provide strategic legal guidance and support to R&D business partners on clinical development activities, including early- and late-stage clinical trials, investigator-initiated studies, collaborative research, external research collaborations and other R&D initiatives.
- Support program, portfolio and study-level reviews by identifying legal and compliance considerations, assessing potential risks, and advising on appropriate mitigation strategies.
- Advise on the interpretation and practical application of applicable laws, regulations, industry codes, GCP requirements and Johnson & Johnson policies in support of compliant business decision-making.
- Conduct and support legal risk assessments for proposed clinical development activities, including novel or complex research models, external collaborations, cross-border activities and evolving regulatory issues.
- Partner with cross-functional stakeholders to evaluate business objectives, identify legal issues, develop practical solutions and support well-considered decisions that enable compliant business success.
- Develop and implement legal guidance, training materials, policies, practices and governance tools to promote consistent, efficient and compliant support for clinical research activities across EMEA.
- Provide legal input into operational processes, escalation pathways and governance forums to support effective issue resolution, timely legal escalation and risk management.
- Serve as a trusted legal partner to regional and global R&D teams, providing clear, practical and solutions-oriented advice on key strategic, operational and compliance matters.
- Draft, review and provide legal oversight for clinical research-related agreements, templates and related documentation, and support negotiation strategy and issue resolution for complex, novel or cross-regional matters.
- Partner with business and functional stakeholders to support contract-related negotiations, escalate material legal or compliance issues as appropriate, and help drive practical, risk-based resolution of agreement-related matters.
- Collaborate closely with other regional R&D lawyers and legal colleagues in regulatory, , intellectual property, litigation, and other relevant functions to ensure aligned and comprehensive legal support.
- Work in a multi-disciplinary, diverse and evolving environment, collaborating with Global Development, Global Clinical Operations, Therapeutic Area Delivery Units, Post-Approval Delivery Unit, Medical Affairs, Regulatory Affairs, Healthcare Compliance, Privacy, Tax and other business or supporting functions in furtherance of the company’s R&D activities.
Required Skills & Capabilities- Strong ability to provide strategic legal guidance on complex clinical development matters and translate legal, regulatory and compliance requirements into practical, business-oriented advice.
- Demonstrated ability to conduct legal risk assessments, identify emerging issues, evaluate mitigation options and guide stakeholders through complex or ambiguous matters.
- Ability to support program, portfolio and study-level reviews by applying sound legal judgment and a practical understanding of clinical development operations.
- Strong understanding of the legal and regulatory framework applicable to pharmaceutical R&D, clinical research, GCP and related industry standards, with the ability to apply that knowledge in a practical and risk-based manner.
- Excellent judgment, consultative and analytical skills, with the ability to assess risk, identify practical solutions and support sound decision-making.
- Strong communication, drafting, counseling and influencing skills, including the ability to explain complex legal concepts clearly and effectively to business stakeholders.
- Client-oriented and solutions-focused, with the ability to proactively engage with stakeholders, understand business objectives and partner on compliant and practical outcomes.
- Ability to work effectively in a multinational and cross-border environment, engaging with regional and global teams across legal, compliance, regulatory, clinical operations and other functions.
- Ability to influence and work collaboratively at all levels and across functions.
- Self-starter with strong drive for results, ownership and independence, balanced with good judgment on when to escalate or seek alignment.
- Comfortable working as part of a global team, with openness and flexibility to take on new or varying responsibilities in a changing environment.
- Able to lead by example, promote high ethical, legal and compliance standards, and proactively identify opportunities to enhance legal and compliance approaches.
Qualifications- Master of Laws degree, having obtained excellent results.
- Minimum of 7 years of legal experience, with a minimum of 5 years supporting R&D, clinical development, life sciences, healthcare or another highly regulated industry.
- Strong practical experience providing legal guidance on clinical research, clinical development, external research collaborations or related R&D activities.
- Experience conducting legal risk assessments and advising on program, portfolio or study-level issues in a regulated environment.
- Comprehensive knowledge of current laws, regulations and industry standards governing R&D and clinical research, including national and European rules and regulations, ICH Guidelines and GXPs.
- Experience advising on clinical research-related agreements and related documentation preferred, but with primary emphasis on broader legal counseling, risk assessment and strategic support.
- Fluent in written and spoken English.
- Experience in multinational corporations; healthcare industry experience preferred.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Agility, Commercial Laws, Compliance Management, Corporate Governance, Dispute Resolution, Lawyering, Legal Services, Litigation, Negotiation, Organizing, Process Improvements, Representing, Strategic Thinking, Tactical Thinking, Technical Credibility