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Medical Information Officer – Regulatory Review

Indegene · Allemagne

Neu
🇬🇧 English

Stellenbeschreibung

About the role

Indegene is seeking a Medical Information Officer to lead regulatory and compliance review of promotional and scientific communication materials for pharmaceutical products in the German market. The role supports our clients by ensuring all medical content meets strict regulatory standards before release.

Key responsibilities

  • Conduct Code Compliance Checks and provide final approval/sign‑off for promotional and medical assets.
  • Verify that medical and scientific information is accurate, balanced, and aligned with the product’s marketing authorization.
  • Ensure advertisements comply with German SPC and PIL requirements, including approved indications.
  • Review claims, comparisons, and references for substantiation and relevance to the target audience.
  • Advise on regulatory acceptability of content and guide the material review team on compliance matters.

Required profile

  • Consultant experience in regulatory, compliance, or nominated signatory review for pharmaceutical promotional materials.
  • Strong knowledge of German pharmaceutical advertising regulations and codes of practice.
  • Ability to interpret and apply SPC, PIL, and label information to marketing content.
  • Excellent attention to detail and a commitment to scientific accuracy.

Required skills

  • Regulatory review and medical‑information compliance expertise.
  • Familiarity with German pharmaceutical advertising regulations.
  • Experience as an MLR (Medical‑Legal‑Regulatory) subject‑matter expert.

What we offer

  • Opportunity to work with a global, AI‑enabled material review team.
  • Exposure to leading life‑science clients across Europe.
  • Professional growth in a technology‑driven healthcare environment.

Questions fréquentes

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Indegene

Allemagne