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Global Risk Management Strategist
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob Summary:As a key member of the Innovative Medicines team, the Group Head, Global Aggregate Reports & Risk Management will lead a group 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.This...
Group Head, Global Aggregate Reports and Risk Management
hace 2 meses
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 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 matrices.
Key Responsibilities:
- Deliver High-Quality Results: Responsible for timely high-quality deliverables through direct involvement in processes or through assignments, considering 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.
- Lead and Develop a Team: Responsible for recruiting, developing, and retaining Senior Global RMP Managers, Senior Medical Writers, and AR&RM Analysts. Develop and implement an onboarding program for new hires. Provide operational and strategic guidance on RMP & AR processes, policy, templates, and training.
- Collaborate with Global Leadership: Member of the AR&RM Leadership Team. Collaborate with the Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
- Advise and Influence: 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.
- Develop Tools and Processes: 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.
- Expertise and Representation: Act as AR&RM Subject Matter Expert (SME) in inspections and audits, including handling of pre-inspection/audit requests, participating in interviews with inspectors/auditors, and supporting CAPAs.
- Collaborate with Partnerships: Act as AR&RM SME for assigned collaborations at early stages of partnerships, e.g., integrations, mergers, and acquisitions. Influence these collaborations beyond Patient Safety, in global and local cross-functional and cross-divisional aspects of RMP, e.g., Regulatory Affairs, Marketing, Countries, which impact worldwide launches.
- Represent AR&RM: Represent AR&RM in MSRB, GLC, GPTs & SMTs, and other relevant boards/teams, and provide expert opinion as required.
- Evaluate and Comply: Evaluate the impact and ensure compliance in collaboration with OPEX of worldwide regulations and industry practices on current AR&RM plans strategy, processes, and tools, e.g., ensure the templates and internal guidance on strategy are in accordance with new/changing regulations.
- Design and Maintain Metrics: In collaboration with OPEX and the AR&RM office, design, develop, and maintain metrics to monitor quality of RMPs & AR, and escalate to Head of department, QPPV, PS&PV leadership, and cross-functional boards any potential risk and issues.
- Develop Training: Provide input into the development of regular and up-to-date AR & RM training to the organization, namely SMT/GPTs, Medical Safety, Regulatory, Quantitative Safety and Epidemiology, Clinical, Medical Affairs.
- Deputize for Global Head: Deputize for the Global Head Aggregate Reports & Risk Management, e.g., MSRB for AR & RMP related aspects, and strategic initiatives.
