Jazz Pharmaceuticals - Philadelphia, PA
posted 4 months ago
The Associate Director of Global Risk Management at Jazz Pharmaceuticals plays a pivotal leadership role within the GRADS Team, focusing on risk minimization activities for the company's products on a global scale. This position is integral to the development and maintenance of effective risk management strategies, particularly in relation to the US REMS and the Jazz Success Program in Canada. The Associate Director will act as a subject matter expert, facilitating collaboration across various functional teams and ensuring that risk management operations align with regulatory requirements and best practices. In this role, the Associate Director will be responsible for building and leading a high-performance Risk Management team, providing strategic input to workstreams, and assisting in the operational aspects of risk minimization. The individual will work closely with departments such as REMS Operations, Pharmacovigilance (PV) Operations, Regulatory Affairs, and Market Research, among others, to ensure compliance and effective program delivery for investigational and marketed products. The Associate Director will also be accountable for fostering strong working relationships within GRADS and across the organization, ensuring timely and accurate communication regarding risk management activities. Key responsibilities include providing strategic advice on risk management planning, developing and revising standard operating procedures (SOPs), and facilitating organization-wide understanding of REMS programs. The Associate Director will also support continuous improvement initiatives, manage relationships with external vendors, and contribute to the resolution of conflicts within teams. This role may involve line management responsibilities, mentoring team members, and participating in audits and inspections to maintain compliance with industry standards and regulations.