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

Job Description Summary

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

Skills Desired