Associate Director, US Medical Review Committee Operations

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The position of Associate Director, US Medical Review Committee (MRC) Operations is responsible for the overall implementation of strategic and complex projects within the US Medical Review organization and cross functionally. The Associate Director is responsible for all oversight and day-to-day operations associated with medical, legal, and regulatory review of non-promotional materials. Collaborate with therapeutic area US Medical Affairs teams, Regulatory, Legal, Compliance, and Medical Communications to ensure best practices, long-term planning, quality, and compliance with policies and standard operating procedures (SOPs). This includes coordinating and collaborating with the Medical, Legal and Regulatory leadership on execution of core projects, system enhancements, and operations related to vendor oversight and management. Guide and coordinate external agencies and vendor activities to ensure effective and efficient adherence to established SOPs. Develop and manage all applicable SOPs, working practices/instructions, training materials and ensure that all applicable MRC team members are trained accordingly.

YOU WILL BE RESPONSIBLE FOR:

• Providing oversight of US Medical Review Committee (MRC) process including maintaining system, training, management of coordinator, Standard Operating Procedures (SOPs)
• Assisting with project planning, development, and maintenance of departmental Policies, Standard Operating Procedures (SOPs); Work Practice Documents (WPDs); and related training materials (e.g., training matrices, training modules, learning management system training assignments) for all departmental, contracted and vendor employees.
• Developing and delivering durable and live trainings, including interactive training modules
• Interacting effectively and collaboratively with therapeutic area Medical Affairs teams, Medical Communications, Compliance, Legal, Regulatory, and other MRC stakeholders
• Working collaboratively with US Promotional Review Committee (PRC) Operations team to support tactical planning process to consolidate database and process enhancements and to coordinate training requirements.
• Assisting in executing tactical deliverables identified during US Medical Communications objective setting and based on departmental strategic imperatives.
• Assisting with budget planning, forecasting, accruals
• Overseeing the development and execution of departmental dashboards, metric reports, tracking, departmental communications to cross-functional partners (e.g., Global Medical Affairs; MRC team members), and departmental project plans.