Job Description Summary
As Legal Counsel supporting Global Medical Affairs and Quality, you\'ll provide strategic guidance on GxP matters across Development and Biomedical Research. This high-impact role offers a unique opportunity to shape compliance and influence decision-making in a dynamic, science-led environment. If you\'re passionate about partnering with cross-functional teams and driving excellence in global standards, we would love to hear from you.
Location: Basel, Switzerland
Job Description
Key Responsibilities:
* Strategic Legal Partnering – Lead legal support for Global Medical Affairs (GMA), including Medical Affairs Excellence and Governance, evidence generation, Scientific Communication and field medical activities.
* Legal & Medical Governance Leadership – Provide pragmatic legal counsel to advance GMA strategies across the enterprise providing pragmatic counseling and proactively identifying opportunities and solutions that reflect a solid understanding of needs across the Novartis enterprise and RDC continuum.
* Global Standards & Controls – Advise on creation and implementation of global standards and processes for medical programs (e.g., Investigator Initiated trials, non-interventional studies, and managed access programs).
* Evidence Generation Strategy – Counseling on the development of global evidence generation strategies involving Phase 3, Phase 4, real world evidence, investigator-initiated trials and in-licensing programs for various products to address US and top market needs and address priority evidence gaps to optimize access and clinical adoption.
* Strategic Scientific Communication Compliance – Guide compliant execution of medical education and communications across the Global, International and U.S. Medical Affairs organizations and embed best practices.
* Cross-Functional Coordination – Ensure consistency across global, international, and U.S. Medical Affairs.
* Regional Support – Provide legal guidance to regional Medical Affairs and Quality teams.
* Governance Board Engagement – Assist and deputize for Head Legal Global Medical Affairs, PS PV and Quality on cases brought to GGO Governance Board.
* Training & Oversight – Deliver legal training and compliance guidance across global functions on risks in the Medical Affairs area.
* R&D Quality Legal Support – Advise on Quality (GxP) issues in Biomedical Research and Development collaborating with Quality Assurance, Legal Operations and all relevant teams.
* Compliance & Risk Management – Ensure adherence to laws, regulations, policies, and legal governance. Advise on compliance issues, policies and operations as they relate to medical, GxP activities, and coordinate pharmacovigilance related matters with the R&D Legal Head Safety.
* External Landscape Monitoring – Track legal and industry trends to proactively advise senior leaders.
Essential Requirements:
* Law Degree or equivalent & licensed to practice law (e.g. admitted to the Bar or equivalent)
* Proficiency in English required – spoken & written
* Demonstrated post qualification experience required: ideally gained within a healthcare / pharmaceutical environment, or alternatively, with a top-tier law firm representing healthcare & technology clients.
* Strong proficiency in analyzing complex legal issues - Excellent problem-solving skills
* Strong verbal & written communication skills; high ability to influence and negotiate.
* Demonstrated competence in working within tight timelines and demanding clients/business partners.
* Sound experience in handling a high volume of activity involving multiple, complex projects simultaneously.
* Professional & culturally sensitive work ethic.
* Demonstrated competence in high pressure environments – with a proactive approach and curious mindset.
* Ability to work collaboratively in cross-functional and multi-cultural teams.
* Strong Business acumen and ability to manage change.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in any order to receive more detailed information about essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
* Administrative Law
* Automated Process
* Behavioral Economics
* Business Acumen
* Business Partners
* Compliance Risk
* Conflict Management
* Empathy
* Finance
* Law (Legal System)
* Legal Advice
* Litigation Law
* Mergers and Acquisitions (M&A)
* Microsoft Office
* Public Speaking
* Quick Learner
* Results-Oriented
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