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.
- 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.
• 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.