Medical Goverance Lead – Scientific Affairs

Location: Montreal, #LI-Hybrid
About the role:
We are looking for innovative, experienced and passionate communicators who want to have an impact and make a difference joining us to reimagining medicine. As a Medical Governance Lead (MGL) you will be responsible for the Governance of GxP and other regulated medical affairs (MA) activities in Canada. The MGL supports strategy execution by providing sustainable governance solutions and by monitoring systems, processes and risk management activities..
The role reports directly into the CSO and VP scientific Affairs and will work closely with the medical leadership and cross functional teams.
Key Responsibilities:
• Monitor full project lifecycle adherence to Novartis MA processes, standards and country regulations, including overseeing KPI/KQIs using existing Country/Regional/Global systems & tools, as applicable
• Proactively identify potential MA risks and support risk management and mitigation to improve future audit/inspection performance, as well as provide insights for continuous improvement of procedures, KPIs and KQIs.Lead insights-driven integrated communications for disease awareness & activation campaigns, media milestones.
• Support country-level governance discussions, as applicable, between MA and internal collaborators, such as Global Governance Office (GGO), GDO/SSO, QA, Patient Safety (PS), Clinical Disclosure Office (CDO), ERC, Procurement, Legal, etcBuild appropriate program engagement strategy, ensuring cross-functional alignment, including where relevant budget and resource allocation management.
• Actively participate in regional/global MGL Network in order to ensure continuous procedural improvement (e.g. development or improvement of training materials, SOP/WP/Guidance, Tools, KPI/KQIs, systems, platforms, etc). May be called upon to lead/co-lead workstreams or working groups.

Essential Requirements:
• Scientific Degree: BSc, MSc, PhD, PharmD or equivalent.
• Extensive and relevant experience in pharmaceutical industry in compliance (at least 5 years).
• In depth understanding of GCP, ICH, and all applicable Canadian laws and regulations.
• Strong collaborative attitude and ability to manage complex projects in cross functional teams.
• Resilience and agility with strong leadership, collaboration, communication, presentation and negotiation skills.
• Initiative, self-motivation and superior organizational and time management skills
Desirable Requirements:
• Experience in the Pharmaceutical industry
• Bilingual: English and French an asset
Novartis
Our purpose is to reimagine medicine to improve and extend people’s life and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network