Description
Objectives/Purpose:
The Medical Review (Responsible person for Information and Publicity) and Excellence Manager serves as the single point of contact for medical review and approval processes, ensuring compliance with local laws, industry codes, and internal standards. This role oversees the lifecycle of medical quality documentation, supports operational excellence within the medical team, and leads process improvement initiatives.
Accountabilities:
1. Medical Review Leadership:
Act as the Responsible Person for Information (RIP), ensuring expertise in medical review processes.
Lead the review and approval of promotional, medical-to-medical, and corporate materials.
Ensure compliance with Belgian regulations, EFPIA, and pharma.be codes.
2. Compliance & Risk Management:
Enforce rigorous review standards to minimize compliance risks.
Consult with Marketing and Medical teams on content creation.
Maintain documentation and audit readiness for reviewed materials.
3. Process Optimization:
Lead training and continuous improvement initiatives.
Act as a super-user of electronic approval systems (e.g., Veeva, PromoMats).
4. Metrics & Reporting:
Analyze performance metrics related to medical review.
Report to leadership on review efficiency and compliance trends.
5. Medical Quality Oversight:
Enhance SOPs and work instructions.
Streamline operations and documentation practices.
Support audits and maintain audit-ready documentation.
Lead digital transformation initiatives.
6. Support for Medical Information:
Respond to medical inquiries and conduct training.
Review promotional materials and participate in cycle meetings.
Education, Behavioral Competencies, and Skills:
7. Advanced degree in Pharmacy or Medicine.
8. Minimum of 5 years of experience in Medical Affairs, Regulatory, or Compliance and Responsible person for Information and Publicity
9. Deep understanding of Belgian pharmaceutical regulations and industry codes.
10. Strong communication and stakeholder management skills.
11. Fluent in Dutch, French, and English.
12. Proficiency in electronic approval systems and compliance platforms.
13. Project management and analytical skills.
Locations
Brussels, Belgium
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time