Medical Governance Lead

Job Description Summary

#LI-Hybrid

Location: Toronto, Ontario

This role is based in Toronto, Ontario Canada. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Help shape trusted, agile and high-quality Medical Affairs execution in Canada. As Medical Governance Lead, you will provide end-to-end governance for GxP and other regulated Medical Affairs activities. You will translate complex requirements into pragmatic, sustainable solutions, strengthen audit and inspection readiness, and enable efficient, risk-based decision-making. Working across Medical Affairs and partner functions, you will help ensure that governance enables quality, operational excellence and effective execution while maintaining high ethical and compliance standards. delivery.

This job posting is for an existing position.

Job Description

Key responsibilities

• •Lead end-to-end governance of regulated Medical Affairs activities, including interventional and non-interventional studies/real-world evidence, investigator-initiated trials, managed access programs and research collaborations.
• •Monitor adherence to Novartis processes, standards and applicable Canadian requirements, while supporting data quality and integrity across Medical Affairs.
• •Ensure compliance and robust medical governance in the medical affairs’ external engagements and events processes.
• •Provide expert governance advice, coaching and practical, risk-based solutions to activity owners and Medical Affairs teams.
• •Proactively identify, assess and mitigate risks; track issues, deviations, escalations and CAPAs through resolution.
• •Oversee local audit and inspection readiness and execution in close partnership with Quality Assurance, and apply root-cause insights to improve future performance.
• •Monitor and report KPIs and KQIs using relevant global systems and tools, and use insights to strengthen processes, capabilities and decision-making.
• •Act as the Medical Affairs governance point of contact for partner functions including GGO, Development Operations, Quality Assurance, Patient Safety, Clinical Disclosure Office, Ethics, Risk & Compliance, Procurement and Legal.
• •Advise activity owners on due diligence, governance and oversight of third parties engaged in evidence and data-generation activities.
• •Support Medical Affairs onboarding, learning and capability-building, and promote consistent, simplified and effective ways of working across Canada.

Essential requirements

• •Scientific degree such as BSc, MSc, PhD, PharmD or equivalent.
• •At least 5 years of relevant pharmaceutical-industry experience in Medical Affairs governance, quality, compliance, clinical development or a related regulated environment.
• •Strong knowledge of GCP, ICH guidelines and applicable Canadian regulations, with practical understanding of scientific and operational aspects of clinical development and Medical Affairs.
• •Demonstrated leadership in risk assessment, audit and inspection readiness, issue management, CAPA, process excellence and continuous improvement.
• •Ability to communicate complex requirements in clear, practical terms and influence effectively across senior, cross-functional and matrix stakeholders.
• •Strong planning, prioritization, negotiation, problem-solving and change-management capabilities, with a pragmatic and solution-oriented mindset.
• •French speaking and writing: Advanced; English speaking and writing: Advanced.

Desirable requirements

• •Experience leading or co-leading governance, quality, capability-building or process-improvement workstreams in a complex matrix organization.
• •Hands-on experience with Medical Affairs systems and governance of evidence-generation, third-party oversight, grants, training and onboarding activities.

Why join us?

This is an opportunity to join a passionate, collaborative Medical Affairs team and make a meaningful contribution to Medical Governance in Canada. You will help turn governance into an enabler of quality, speed, consistency and trusted decision-making, while shaping sustainable ways of working across the organization.

About Novartis Canada

At Novartis Canada , we are determined to be a valued partner and advocate, with a deep understanding of patient needs along the entire care journey – from drug development, to diagnosis, to access and beyond. Part of the way we are doing this is by leveraging data, technology, and partnerships.

Research & Development : we focus on four core therapeutic areas: Cardiovascular, Renal & Metabolic, Immunology, Neuroscience and Oncology. We also develop and deliver treatments through other promoted and established brands, which today are helping millions of patients. Over the last three years, our average annual research and development investment in Canada was over $30 million, and we conduct clinical trial research in every region throughout Canada.

Commitment to Diversity and Inclusion : Novartis is committed to building outstanding, inclusive work environment and diverse team’s representatives of the patients and communities we serve.

Skills Desired

Change Agility, Change Agility, Clinical Protocols, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Evidence Generation, Graduate Medical Education (GME), Healthcare Industry, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Medical Affairs, Medical Communications, Patient Care, People Management, Pharmaceutics, Product Launches, Product Strategies, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies, Results-Oriented {+ 3 more}