Medical Operations Manager

Job Description - Medical Affairs Operations Manager

As a leading specialty healthcare company, they are committed to advancing medical innovation and optimizing patient outcomes. Medical Affairs plays a vital role in ensuring the efficient execution of medical strategies while maintaining compliance so we are looking for an operations manager that allows the team to run efficiently.

Operational Framework

• Establish an operational Medical Affairs framework to support the implementation of medical activities, including the integration of innovative digital technologies.
• Oversee the operational aspects of medical programs, projects, and responsibilities in close collaboration with other Medical Affairs functions, such as: Medical Information, Scientific Communication, Real-World Evidence & Medical Education

Process Improvement and Monitoring

• Identify and implement process improvements to enhance the efficiency and effectiveness of medical operations.
• Define, review, and provide training on Standard Operating Procedures (SOPs) to ensure that Global Medical initiatives and responsibilities are conducted efficiently and in compliance with all relevant internal and external regulations.
• Develop and monitor suitable Medical Affairs Key Performance Indicators (KPIs) to measure success and impact based on defined expectations.
• Support national and regional Medical Affairs teams in implementing Global KPI standards.

Budget Management and Controlling

• Establish and coordinate the budgeting and forecasting process.
• Oversee budgets related to Global Medical Affairs to ensure cost-effective resource utilization.
• Collaborate closely with the Global Medical Head, respective Global Medical Leaders (GMLs), and the finance team to ensure timely and accurate budget management.

Compliance and Regulatory Support

• Ensure all medical operations comply with applicable regulations.
• Support the preparation and submission of regulatory documents, such as Periodic Safety Updates.

Investigator-Initiated Trial (IIT) Governance

• Provide operational expertise and support for the Investigator-Initiated Trial (IIT) program.
• Oversee and manage IIT activation processes and follow up on project execution in accordance with IIT SOPs.
• Maintain the IIT database and ensure proper documentation of program progress, including milestone tracking and payment monitoring.
• Work closely with the IIT Chair, respective GMLs, and the finance team to ensure accurate and timely budget management.

Other Duties as Assigned

• Serve as a deputy to other team members and a point of contact for affiliate countries.
• Assist with additional duties related to Global Medical Operations or Project Management as needed.