Senior R&D Counsel, Global Medical Affairs (GMA) and Quality

Band

Level 6

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’d love to hear from you.


#Hybrid
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 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.

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