Global Risk Management Lead

hace 6 días


Barcelona, Barcelona, España Innovative Medicines A tiempo completo
About the Role

The Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in developing robust Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies. This role is aligned with the benefit-risk profile of the products and supported by complex stakeholder matrices.

Key Responsibilities
  • Responsible for timely high-quality deliverables through direct involvement or assignments, considering individual workload, experience, location, business needs, and individual development needs.
  • Interacts with GPTs and Functions to ensure proper prioritization of programs and assign adequate resources.
  • Aligns support provided by Global (Sr) RMP Managers/(Sr) Medical Writers/AR&RM Analysts to Global teams in developing and maintaining Safety RMPs, RMP strategy, and Aggregate Reports with business rules, regulatory guidance, and company standard operating procedures.
  • Responsible for recruiting, developing, retaining (Sr) Global RMP Managers/(Sr) Medical Writers/AR&RM Analysts, developing and implementing an onboarding program for new hires.
  • Provides operational and strategic guidance on RMP & AR processes, policy, templates, and training.
  • Responsible for AR & RM team objectives according to company and department priorities, development plans, and ongoing feedback on performance of direct reports.
  • Member of the AR&RM Leadership Team.
  • Collaborates with Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
  • Advises and influences the organization regarding Aggregate Reports & Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide as well as for lifecycle management by close connection with stakeholders and industry peers.
  • Guides a cross-functional matrix in the development of tools for RMP preparation, implementation tracking, working practices, and guidelines, implementation of regulatory guidance, and Safety RMP project management.


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