Assistant Medical Information Manager

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; 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
  
  

Qualified vendors with clear MSA/SOW/SDEA; SLA/KPI targets met; issues tracked to CAPA; deviations/waivers managed via QMS; alignment with SOP‑GM‑26.03 and related WIs/templates.

• Metrics, Insights & Continuous Improvement
  
  

U.S. MI dashboards (timeliness, quality, AE/PQC routing, channel analytics) published; trend insights drive prioritized content updates/congress readiness; closed‑loop improvements documented.

• Audit/Inspection Readiness & SOP Governance
  
  

SOP/WI ownership and periodic reviews completed; training currency maintained; mock audits performed; inspections/audits supported with zero critical observations attributable to MI.

• U.S. MA Partnership (RACI‑Bounded)
  
  

Clear handoffs: MA triages on‑site at U.S. events and hands off to MI; MI fulfills/documents; escalation playbooks and SLAs maintained across time zones.

• Training & Enablement
  
  

MI onboarding/refresher delivered to MI/vendors/partners (unsolicited requests, documentation, PV/PQC intake, privacy); targeted job aids for field/MA booths; training completion ≥95%

Key Interfaces / Interactions

External Interfaces

• Approved MI service vendors/ contact centers and medical writing partners (SOW/MSA/SDEA governed)
• Congress /medical meeting organizers (logistics for MI triage enablement; no promotional engagement)
• HCPs/patients/caregivers only via approved MI channels (phone/web/email/chat/portal/social media etc), strictly non‑promotional
• Auditors/inspectors (as required; front-/back‑room support coordinated with QA/PV)
  
  

Internal Interfaces (Other Than Direct Reports)

• Global Medical Information Team
• Global Pharmacovigilance Team (GPV)
• Regional Medical Information Points of Contact (MI POCs) and Regional MI Points of Contact for global content harmonization, surge support
• Medical Affairs Team, U.S.-based Medical Affairs Manager (Scientific Services) for in country context, congress triage, escalation support
• Regulatory Affairs/Labeling- USPI changes, safety communications, change control
• Quality Assurance (QA)/ PVQA/ QMS QA Team- deviations, CAPAs, vendor qualification, audits/inspections
• IT/ Digital Team- MI platforms/CRM, channel uptime, access control, reporting, SharePoint and data management support
• Finance Team (for vendor-related financial processes), if any.
• Internal Audit teams (supporting the internal audit)
• Production/ Formulations and development team
• Marketing/ Commercial team- clear separation of promotional vs. non‑promotional activities and materials
• Product Management Team
• Legal Team
• Prescribing Information Stakeholders
• Product Development Cell (PDC Team)
  
  

Knowledge, Skills And Abilities

• Education :
• 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).
• Experience collaborating with PV, QA, Regulatory Labeling, Compliance/Legal, and Digital/IT for MI channels, systems, and data integrity.
• Comfortable working U.S. time‑zone overlaps and managing cross‑time‑zone teams/stakeholders.
• Deep understanding of non‑promotional MI standards, unsolicited request handling, and documentation discipline (verbatim capture, medical references, audit trails).
• Strong command of U.S. Prescribing Information (PI) alignment and change control; ability to lead SRD/FAQ life cycle and ensure scientific balance and evidence hierarchy.
• Working knowledge of U.S. privacy expectations (e.g., HIPAA‑aligned practices for PHI in MI channels), GDPR, AE/special situation intake, and PQC routing processes with PV/QA.
• Proficiency with MI platforms/CRMs (case management, content libraries, reconciliation, metrics) and SharePoint/knowledge repositories; fluency in creating and reading MI dashboards (quality/SLAs, content utilization, trends).
• QMS literacy: deviations, CAPA, change control, and SOP/WI/template governance aligned to MI Control Docs.
• Excellent scientific writing and evidence appraisal skills; able to coach writers/vendors and enforce consistency, tone, citations, and disclaimers.
• Risk‑based thinking and inspection‑ready rigor in everyday operations.
• Leadership / Managerial Attributes
• Demonstrated ownership mindset for end‑to‑end MI operations with clear RACI boundaries (keeps MI accountable; partners with U.S. MA for in‑country context and triage).
• Builds a culture of quality, compliance, and service excellence; coaches teams/vendors through calibration and continuous improvement.
• Data‑driven decision‑making; proactively identifies risks, trends, and insights and converts them into actions (content updates, process fixes, training).
• Strong stakeholder management across PV/QA/RA/Compliance/MA/IT; effective communicator across time zones.
• High organizational agility—able to pivot during label changes, launches, or inspections while maintaining day‑to‑day service stability.
• Other requirements (licenses, certifications, specialized training
• Mandatory: Company Code of Conduct/GxP and PV awareness training (AE/PQC intake basics) within onboarding timelines.
• Preferred: MAPS/MILE/phactMI coursework/certifications; quality systems or auditing certifications.
• Work pattern: Willingness to support U.S. time‑zone overlap windows; limited travel for audits, vendor calibration, or global MI workshops

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