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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob SummaryAt Innovative Medicines, we are seeking a highly skilled professional to lead our Global Aggregate Reports & Risk Management team. As the Group Head, you will be responsible for developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.About the RoleThe Group Head, Global...
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Global Risk Management Lead
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob Title: Group Head, Global Aggregate ReportsAbout the Role: We are seeking a highly skilled and experienced professional to lead our Global Aggregate Reports and Risk Management team. As the Group Head, you will be responsible for developing and implementing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned...
Global Head of Aggregate Reports and Risk Management
hace 2 meses
The Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans (RMPs) and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements, industry trends, and business needs.
Key Responsibilities:- Lead a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in the development of RMP strategies and Aggregate Reports.
- Collaborate with cross-functional teams, including Global Product Teams, Regulatory Affairs, and Medical Writing, to ensure alignment with business objectives and regulatory requirements.
- Develop and implement an onboarding program for new hires and provide operational and strategic guidance on RMP and AR processes, policy, templates, and training.
- Advise and influence the organization on Aggregate Reports and Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide.
- Guide a cross-functional matrix in the development of tools for RMP preparation, implementation tracking, working practices, and guidelines.
To be successful in this role, you will need:
- Proven leadership experience in Risk Management and Regulatory Affairs, with a strong track record of developing and implementing RMPs and Aggregate Reports.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and stakeholders.
- Strong analytical and problem-solving skills, with the ability to interpret complex data and regulatory requirements.
- Knowledge of regulatory requirements, industry trends, and business needs, with the ability to apply this knowledge to develop effective RMP strategies and Aggregate Reports.