Medical Governance Lead

Lead on Medical Governance for the UK CPO with a focus on high standards and continuous improvement in materials and GxP processes across the medical function.

About the Role

Major accountabilities:

• Proactively identify risk and support risk management and mitigation.
• Oversee and monitor local audit & inspection readiness and execution, related to medical affairs activities.
• Oversee local CAPAs and operational monitoring relating to medical affairs to ensure rapid resolution, escalation and proactive identification of wider implications.
• Monitor and report KPI/KQI using existing Global systems & tools.
• Lead the End-to-End medical governance of regulated activities (Interventional and NIS/RWE, IIT, MAP, RC) and promotional and non-promotional materials generation.
• Provide governance support, advice, coaching and expert input to the local MA activity owners and teams.
• Acts as country expert on MA processes, Novartis standards, compliance and local regulations.
• Monitor adherence to Novartis processes, standards and local regulations.
• Proactively participate in regional/global Medical Governance networks for ensuring continuous improvement.
• Chairs the Local Medical Affairs Council (LMAC).
• Single point of contact for partner functions.
• Training Responsible Person for Medical Affairs.

Requirements:

• Significant experience of working in Medical affairs or in a Compliance/Clinical Trials focused role in Pharmaceutical company.
• Deep and detailed understanding of the process of GXP.
• UK understanding and experience is beneficial.
• Operations Management and Execution experience.
• Negotiation and problem-solving skills.
• Proactive and team-player approach for managing effective international and cross-divisional/matrix collaboration.
• Pragmatic, solution oriented and solid “sense for risk assessment” attitude.

Location:

London based role on a hybrid basis of 12 days per month in the London office.

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.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives 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!

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.