Head of Medical Affairs

il y a 4 semaines


Asse, Belgique Novellas Healthcare Temps plein

Permanent
- Pharmaceutical
- Are you a talented individual with a passion for strategic leadership and a commitment to better patient health? Join a growing team and contribute to the mission of the creation of a brighter future for the patients we serve.

**Vacancy information**:
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 onboarding, 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.

**Requirements information**:

- Extensive medical experience and a Medical degree.
- Advanced management degree (e.g., MBA, MPH, MHA) is an advantage
- Minimum 3 years in a team environment, including supervisory experience.
- Minimum 6 years of pharmaceutical industry experience.


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