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Global Head of Risk Management and Aggregate Reports
hace 2 meses
The Global Head of Risk Management and Aggregate Reports is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role is critical in ensuring the company's compliance with regulatory requirements and maintaining a strong reputation in the industry.
Key Responsibilities:
- Lead a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.
- Collaborate with cross-functional teams, including Global Product Teams (GPTs), Functions (e.g., Global Product Heads, Health Product Strategy, Medical Writing, Regulatory Affairs), to ensure proper prioritization of programs and assign adequate resources.
- Recruit, develop, and retain top talent in risk management and regulatory affairs, including (Sr) Global RMP Managers, (Sr) Medical Writers, and AR&RM Analysts.
- Develop and implement an onboarding program for new hires to ensure a smooth transition into the team.
- Member of the AR&RM Leadership Team, collaborating with the Global Head of Aggregate Reports & Risk Management to set departmental objectives and achieve them.
- Advise and influence the organization on Aggregate Reports & Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide.
- Guide a cross-functional matrix in the development of tools for RMP preparation, implementation tracking, working practices, and guidelines.
- Act as AR&RM Subject Matter Expert (SME) in inspections and audits, representing the company's interests and ensuring compliance with regulatory requirements.
- Evaluate the impact and ensure compliance with worldwide regulations and industry practices on current AR&RM plans strategy, processes, and tools, in collaboration with the Operations Excellence (OPEX) team.
- In collaboration with OPEX and the AR&RM office, design, develop, and maintain metrics to monitor the quality of RMPs & AR.
- Provide input into the development of regular and up-to-date AR & RM training to the organization, ensuring that all employees are equipped with the necessary knowledge and skills to perform their roles effectively.
- Deputize for the Global Head of Aggregate Reports & Risk Management and other Group heads when required, ensuring seamless leadership and continuity within the team.
Requirements:
- Scientific degree required, with a life sciences degree being desirable.
- Advanced degree (Masters, MD, PharmD, or PhD) required.
- Fluent in spoken and written English.
About Novartis:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
