Assistant Medical Information Manager

Job Description:

Responsibilities

•  MI Operations Leadership – U.S. Focus and also Global Flexibility -
• End?to?end U.S. MI operations run per MI Control Docs and GMI SOPs; compliant, balanced, timely responses; documented separation of promotional/non?promotional; flexible support to other regions as assigned.
•  Content Governance & Change Control
• U.S. SRDs/FAQs and digital MI content aligned to current U.S. PI and evidence standards; controlled updates for label/safety changes; complete audit trails in repository; periodic content quality reviews passed.
•  Inquiry Handling Oversight, Documentation & Privacy
• Unsolicited, non?promotional fulfillment; accurate verbatim capture; documentation completeness; adherence to privacy expectations (incl. HIPAA?aligned handling where applicable); periodic QC shows ?95% documentation accuracy.
•  Assist GMI Head/ Designee in miscellaneous activities and projects as assigned
• Effective support for strategic and operational initiatives; tasks completed within agreed timelines
•  PV & Product Quality Integration
• Reliable intake and on?time routing of AEs/special situations and PQCs to PV/QA per SOPs and regulatory timelines; reconciliations completed; zero critical PV/QA findings linked to MI channels.
•  Vendor/Partner Management & QMS Alignment