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Global Head of Aggregate Reports and Risk Management

hace 2 meses


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
About the Role

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.
Requirements:

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.