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Senior Legal Counsel, R&D Legal EMEA
Johnson & Johnson. Provide strategic legal guidance and support to R&D business partners on clinical development activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive legal expertise in clinical development and R&D, providing strategic guidance and risk assessment in compliance with applicable laws and regulations. Proficient in drafting and negotiating clinical research agreements while collaborating with cross-functional teams in a highly regulated environment.
Highest-signal resume keywords
Master Of Laws Degree7 Years Of Legal Experience5 Years Supporting R&DLegal Risk AssessmentFluent In English
ATS Keywords
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Hard Skills
Legal GuidanceClinical ResearchRegulatory ComplianceDrafting AgreementsNegotiation SkillsAnalytical SkillsJudgmentCounselingInfluencingCollaboration
Soft Skills
Strategic ThinkingCommunication Skills
Industry Keywords
Clinical DevelopmentLife SciencesHealthcareGCPICH GuidelinesGXPsMultinational CorporationsEuropean RegulationsNational RegulationsExternal Research Collaborations
About the role
Key responsibilities & impact- Provide strategic legal guidance and support to R&D business partners on clinical development activities
- Support program, portfolio and study-level reviews by identifying legal and compliance considerations and advising on mitigation strategies
- Advise on applicable laws, regulations, industry codes, GCP requirements and Johnson & Johnson policies
- Conduct and support legal risk assessments for clinical development activities, external collaborations, cross-border activities and evolving regulatory issues
- Partner with cross-functional stakeholders to evaluate business objectives, identify legal issues and develop practical solutions
- Develop and implement legal guidance, training materials, policies, practices and governance tools across EMEA
- Provide legal input into operational processes, escalation pathways and governance forums
- Serve as a trusted legal partner to regional and global R&D teams
- Draft, review and provide legal oversight for clinical research-related agreements and documentation
- Support contract negotiations, issue resolution and escalation of material legal or compliance issues
- Collaborate with regional R&D lawyers and colleagues in regulatory, intellectual property, litigation and other functions
- Work with Global Development, Global Clinical Operations, Therapeutic Area Delivery Units, Medical Affairs, Regulatory Affairs, Healthcare Compliance, Privacy, Tax and other functions
Requirements
What you’ll need- Master of Laws degree, having obtained excellent results
- Minimum of 7 years of legal experience
- 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 in multinational corporations
- Fluent in written and spoken English
- Strong understanding of the legal and regulatory framework applicable to pharmaceutical R&D, clinical research, GCP and related industry standards
- Strong strategic legal guidance, legal risk assessment, judgment, analytical, communication, drafting, counseling, influencing, negotiation and collaboration skills
Benefits
Comp & perks- An annual bonus with set target (% of pay) depending on pay grade / location, with the actual amount based on employees’ and companies’ performance of the previous calendar year, or sales commissions
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs for financial, physical and mental health
- Service anniversary and recognition awards
- Several insurance plans for employees and, in some locations, eligible dependents