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Senior r&d counsel, global medical affairs (gma) and quality

Basel
Novartis Farmacéutica
F&E
EUR 135’000 pro Jahr
Inserat online seit: 16 Oktober
Beschreibung

Choose LocationChoose Location# Senior R&D Counsel, Global Medical Affairs (GMA) and QualityREQ-10062798Oct 09, 2025Switzerland### SummaryAs 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’d love to hear from you. #Hybrid Location: Basel, Switzerland### About the Role**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 in-volving 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 collab-orating with Quality Assurance, Legal Operations and all relevant teams.* Compliance & Risk Management – Ensure adherence to laws, regulations, policies, and legal governance. Ad-vise 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.**Why Novartis:****Join our Novartis Network:****Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:LegalUniversal Hierarchy NodeSwitzerlandBasel (City)C028 (FCRS = CH028) Novartis Pharma AGLegal & Intellectual Property & Compl.Full timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ-10062798### Senior R&D Counsel, Global Medical Affairs (GMA) and Quality
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