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Global Head, Aggregate Reports and Risk Management
hace 2 meses
About the Role
The Global Head, Aggregate Reports and Risk Management will lead a team of Senior Risk Management Plan Managers, Medical Writers, and Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products and therapies. This role will align with the benefit-risk profile of products and be supported by complex stakeholder matrices.
Key Responsibilities
- Leadership and Strategy
- Responsible for timely and high-quality deliverables through direct involvement or 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.
- Align the support provided by Global Risk Management Plan Managers, Medical Writers, and Analysts to the Global teams in developing and maintaining Safety RMPs, RMP strategy, and Aggregate Reports with business rules, regulatory guidance, and company standard operating procedures.
- Responsible for recruiting, developing, retaining Senior Risk Management Plan Managers, Medical Writers, and Analysts.
- Develop and implement 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 the Global Head, Aggregate Reports and 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.
- 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, e.g., integrations, mergers, and acquisitions.
- 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.
- Drives the internal alignment on the company position with multiple functions and boards involved.
- Oversees the Global Teams' strategies for AR & RMP related responses to Health Authorities.
- Provides input into the development of regular and up-to-date AR & RM training to the organization.
- Deputizes for the Global Head, Aggregate Reports and Risk Management, e.g., MSRB for AR & RMP related aspects, and strategic initiatives.
- Deputizes for other Group heads when required, supporting their teams.
Educational Background
Scientific Degree required. Life sciences degree desirable. Advanced degree (Masters, MD, PharmD, or PhD) required.
Languages
Fluent in spoken and written English.
