16 Aug
|
Glenmark Pharmaceuticals
|
Mumbai
16 Aug
Glenmark Pharmaceuticals
Mumbai
Role Summary:
This role leads the U.S. Medical Information (MI) program from India, ensuring compliant, accurate, balanced, and timely responses to HCP/patient inquiries, with end‑to‑end ownership of U.S. MI operations (content governance, inquiry handling oversight, documentation quality, PV/PQC intake and routing, SLAs/KPIs, audit/inspection readiness etc). Operations are executed per MI Control Documents/ Work instructions/ Policies and applicable U.S. standards (non‑promotional, unsolicited request handling, privacy). The role partners closely with the U.S. based MA Manager (GMA) for in‑country context, event triage, and escalations, while MI retains operational ownership. The position also provides global MI support as needed (shared content, harmonized SOPs, surge coverage) while aligning to regional labels and regulations.
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; adaptable 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 timel
📌 Assistant Medical Information Manager (Mumbai)
🏢 Glenmark Pharmaceuticals
📍 Mumbai