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Global Head, Aggregate Reports and Risk Management
hace 2 meses
The Global Head, Aggregate Reports and Risk Management 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. This role will be responsible for ensuring alignment 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 in processes or through assignments considering individual workload, experience, location, business needs, and individual development needs.
- Interacts with Global Product Teams and Functions to ensure proper prioritization of programs and assign adequate resources.
- Responsible for recruiting, developing, and retaining Senior Global RMP Managers, Senior Medical Writers, and 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.
- 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.
- 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.
- 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.
- Acts 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.
- Acts as AR&RM SME for assigned collaborations at early stages of partnerships, influencing these collaborations beyond Patient Safety.
- Represents AR&RM in MSRB, GLC, GPTs & SMTs and other relevant boards/teams and provides expert opinion as required.
- Evaluates the impact and ensures compliance in collaboration with OPEX of worldwide regulations and industry practices on current AR&RM plans strategy, processes, and tools.
- Collaborates with OPEX and the AR&RM office in designing, developing, and maintaining metrics to monitor quality of RMPs & AR, and escalates any potential risk and issues.
- Provides input into the development of regular and up-to-date AR & RM training to the organization.
- Deputizes for the Global Head Aggregate Reports & Risk Management as needed.
- Scientific Degree required. Life sciences degree desirable. Advanced degree (Masters, MD, PharmD or PhD) required.
- Fluent in spoken and written English.
