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

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 E-Mail schreiben  and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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