Assistant Medical Information Manager

Full time

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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.

Qaulification & Experience

Advanced degree preferred: PharmD / PhD / MPharm (or MSc in Life Sciences with substantial MI leadership experience).
Additional certifications in GxP, Medical Affairs/ MI (e.g., MAPS/MILE/phactMI), or quality systems are an advantage.
Experience:
8 to 12 years total industry experience in Medical Information, with 3-5 years leading US MI/ Global operations (content governance, inquiry handling oversight, vendor management, SLAs/KPIs, PV/PQC handoffs)
Hands?on leadership of vendor/contact center delivery (qualification, calibration, QMS?aligned deviations/waivers, SOW/MSA/SDEA management).