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Global Aggregate Reports and Risk Management Lead
hace 2 meses
The Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers and Senior Medical Writers and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the products and supported by complex stakeholder matrixes.
Your Key Responsibilities Include:- Responsible for timely high-quality deliverables through direct involvement in processes or through assignments taking into consideration individual workload, experience, location, business needs, and individual development needs.
- Interacts with GPTs and Functions (e.g. GPH, HPS, Medical Writing, Regulatory Affairs) to ensure proper prioritization of programs and assign adequate resources.
- Aligns the support provided by Global (Sr) RMP Managers/(Sr) Medical Writers/AR&RM Analysts to the Global teams in developing and maintaining the 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, and 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 the 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.
