Summary:
Client is looking for a Germany -based Consultant with Regulatory or Compliance or Nominated Signatory Review experience as an Medical Information Officer for promotional and scientific communication materials (Pharmaceuticals). The regulatory consultant will work with Client's material review team to support its engagement with the medical Pharmaceutical client partner and serve as a consultant to assist as an MLR SME (especially on Pharmaceutical advertising and promotion regulations) on Pharmaceutical project.
Background
Client partners with life science organizations to provide effective, AI-enabled material review and compliance solutions. We provide comprehensive medical, regulatory, and editorial review services as well as operations support through a team of 350+ experienced professionals. We have a good knowledge of key market regulations and codes of practice and our span of operations covers North American, European, and Asia-Pacific regions.
Responsibilities:
- Serve as an Information Officer for review of promotional and medical materials containing information on pharmaceutical company's marketed products and compounds in development, as well as the corresponding disease states for Germany market
- Medical Information Officer will perform the Code Compliance Check and Final approval/Sign Off before approving asset, which is then released to Production.
- Ensure that medical and scientific information provided to patients and health care professionals is accurate and in compliance with the product's marketing authorization and ensure the advertisements are in line with the German SPC and PIL including the approved indications.
- Review materials and ensure data included are accurate, within context, and presented in a fair/scientifically balanced manner. Verify substantiation of all claims and comparisons. Determine acceptability of references, advise on whether claims are consistent with appropriate approved label, and ensure that the piece is
📌 Medical Information Officer (España)
🏢 Nityo Infotech
📍 España
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