Medical Affairs Project Management & Medical Information

Project Management Medical Education / Signature Events:

Partner to engage seasoned medical project manager who can fully oversee and manage your medical education and signature events. I offer comprehensive management, including coordination with the Scientific Committee and speakers, and handling the internal approval processes. Alternatively, I can collaborate with a local medical advisor, where I assume all back-office responsibilities as the project manager, while the medical advisor handles all external engagements.

Coverage for Medical Affairs:

Utilize Rebien Pharma Consult's external resources to provide coverage and back-up support for Medical Affairs during vacation/vacancy periods, ensuring continuity of operations and regulatory compliance.

Medical Information Competencies:

Partner with Rebien Pharma Consult to provide competencies for medical information services. Thereby ensuring healthcare professionals and patients have uninterrupted access to accurate and timely medical information.  

Governance & Compliance 

Compliance Review & Approval of promotional material:

Rely on me to handle compliance approval tasks of all kinds of promotional material in accordance with local legislation and ENLI rules, ensuring uninterrupted operations.  

Medical Affairs Approval:

Outsource approval processes for medical affairs materials. This streamlines workflow and ensures timely processing.

Preparation of Short Text Based on SmPC:

Outsource the preparation of short text based on SmPC to ensure accuracy, consistency, and compliance with regulatory guidelines. Including upload to Veeva Vault.

Medical Assessment & Regulatory Affairs Interactions 

Stock Keeping Units (SKU) - Regulatory Collaboration:

I can act as the medical affairs partner to assess and provide guidance on SKU-related matters, optimizing inventory management and ensuring compliance with regulatory standards.

Out-of-Stock Medical Assessment:

Outsource medical assessment tasks related to out-of-stock situations for rapid response and resolution, minimizing impact on patient care and regulatory compliance.

Narcotic Suspicious Case Assessment:

Partnering to address narcotic suspicious cases, ensuring appropriate handling and regulatory compliance.

Medical Affairs Partner for Regulatory Work:

Medical Affairs Support to regulatory activities related to all products. Proof reading and language reading of new or updated text to SmPc.

Late-Stage Products - Medical Assessment Regulatory Collaboration:

Partnering with regulatory experts to assess and address regulatory implications of Late-Stage Products (verification of transfer) products, ensuring compliance and facilitating smooth product transfers.