Senior Legal Counsel, R&D Legal EMEA

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function

Legal & Compliance Job Sub Function

Law Business Partners Job Category

Professional All Job Posting Locations

Beerse, Antwerp, Belgium, Diegem, Flemish Brabant, Belgium Job Description

Senior Legal Counsel, R&D Legal EMEA Contract

Full Time - Hybrid Location

Diegem or Beerse, Belgium Role Summary

This 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 Responsibilities

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, elevate 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