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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: As the Global Head of Aggregate Reports and Risk Management at Novartis Farmacéutica, you will lead a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies. Your expertise will be crucial in aligning these strategies with the benefit-risk profile of the products and supporting complex stakeholder matrices.

Your Key Responsibilities Include:

  1. Deliver High-Quality Results: You will be responsible for timely and high-quality deliverables, either through direct involvement or through assignments, taking into consideration individual workload, experience, location, business needs, and individual development needs.
  2. Collaborate with Cross-Functional Teams: You will interact with Global Product Teams and Functions (e.g., Global Product Heads, Medical Writing, Regulatory Affairs) to ensure proper prioritization of programs and assign adequate resources.
  3. Align Risk Management Strategies: You will align the support provided by Global (Sr) RMP Managers, (Sr) Medical Writers, and AR&RM Analysts to the Global teams in developing and maintaining Safety RMPs, RMP strategies, and Aggregate Reports with business rules, regulatory guidance, and company standard operating procedures.
  4. Lead and Develop a Team: You will be responsible for recruiting, developing, retaining (Sr) Global RMP Managers, (Sr) Medical Writers, and AR&RM Analysts, and developing and implementing an onboarding program for new hires.
  5. Provide Operational and Strategic Guidance: You will provide operational and strategic guidance on RMP & AR processes, policy, templates, and training.
  6. Drive Team Objectives: You will be responsible for AR & RM team objectives according to company and department priorities, development plans, and ongoing feedback on performance of direct reports.
  7. Contribute to Leadership Team: You will be a member of the AR&RM Leadership Team, collaborating with the Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
  8. Advise on Regulatory Affairs: You will advise and influence 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.
  9. Develop Tools and Guidelines: You will guide 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.