Senior Medical Advisor (m / w / d)

Hormosan Pharma GmbH – A Lupin Group Company; Frankfurt; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Medical Affairs Operations Manager to enhance medical innovation and optimize patient outcomes. In this pivotal role, you will establish an operational framework, oversee medical programs, and ensure compliance with regulations. Your expertise in budgeting and process improvement will be crucial in driving efficiency and effectiveness within the team. Collaborating with various functions, you will support the implementation of key performance indicators and manage Investigator-Initiated Trials. If you are passionate about advancing healthcare through operational excellence, this is an exciting opportunity for you.

Qualifikationen

• 5+ years of experience in Medical Affairs or related field.
• Strong understanding of regulatory requirements and compliance.

Aufgaben

• Establish and oversee the operational framework for Medical Affairs.
• Identify and implement process improvements for medical operations.

Kenntnisse

Budget Management

Process Improvement

Regulatory Compliance

Project Management

Medical Affairs Knowledge

Ausbildung

Bachelor's Degree in Life Sciences

Master's Degree in Healthcare Management

Tools

KPI Monitoring Tools

Budgeting Software

Jobbeschreibung

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.