Global Aggregate Reports and Risk Management Lead

hace 5 días


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

The Global Aggregate Reports and Risk Management Lead will be responsible for leading a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies. This role will align with the benefit-risk profile of the products and be supported by complex stakeholder matrices.

Your Key Responsibilities

• 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.
• Interact with Global Product Teams and Functions to ensure proper prioritization of programs and assign adequate resources.
• Align 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, developing, and implementing an onboarding program for new hires.
• Provide 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. Collaborate with Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
• 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.
• 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.

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