Head of Medical Affairs

As Head of Medical Affairs, a key leader, your role will involve providing strategic guidance to the Medical Affairs and RA/QA teams. By prioritizing patient needs and safety, you'll play a pivotal role in supporting the overall health and well-being of patients. You'll manage and lead teams, ensuring alignment, collaboration, and compliance within the organization.

Key Responsibilities:

• Contribute to the strategic roadmap of the organization, ensuring future capabilities are developed.
• Align and execute medical plans that are in line with the company strategy and delivered on time.
• Foster a team of highly qualified professionals, motivating them to achieve ambitious goals.
• Support on-boarding, training, and knowledge transfer within the medical and QA/RA departments.

Accountabilities:  

• Medical Affairs Leadership:

• Uphold Global Compliance Standards for Non-Commercial (Scientific) processes.
• Maintain scientific accuracy and ethical standards in medical information, staff training, and product promotion.
• Develop local tactical medical plans, including publications and advisory board meetings.
• Build relationships with Key Opinion Leaders and stakeholders, ensuring a strong network.
• Provide medical input in various areas, from tender business offers to market access negotiations.

• Clinical Research

• Lead the development of comprehensive clinical research plans aligned with global and local functions.
• Ensure the integrity, quality, and timely execution of local clinical studies.
• Oversee local Investigator Initiated Sponsored Research proposals in line with the company’s standards.

• Quality Assurance and Regulatory Affairs:

• Support the implementation of global standards and local SOPs for quality management.
• Oversee GxP documents and regulatory processes, ensuring compliance with local regulations.
• Manage label creation, review, and approval processes.

• Medical Information and Pharmacovigilance:

• Implement a system for handling medical inquiries and ensure accurate and balanced responses.
• Collaborate with global PV representatives to maintain robust Pharmacovigilance processes.

• Patient Services and Solutions:

• Develop patient support programs aligned with BU strategies.
• Collaborate with compliance and legal teams for service creation.
• Manage contracts and track KPIs related to patient services.