Medical Information operations leader

Job Title: Medical Information System Project Manager / Operations Consultant (20-40 hours / 12 -months)

Role Overview Our client is currently transitioning their medical inquiry platform in-house from an outsourced vendor. To support a global rollout—including the EU and Japan—they are seeking an expert to provide strategic project management and operational support as they migrate to a new system (Veeva Med Inquiry). This consultant will initially focus on evaluating existing processes and drafting new Standard Operating Procedures (SOPs), eventually ramping up to manage the system build, outline functional requirements, and oversee a rigorous validation process.

Key Responsibilities

• SOP Strategy & Development: Assess current outsourced operational and safety processes to identify and draft the necessary internal SOPs for the new system, focusing on areas like unsolicited request handling, content development, and user access management.
• System Configuration & Workflow Planning: Define functional requirements and guide system architecture to ensure optimal data-entry workflows, ensuring the system is built correctly the first time to avoid costly rebuilds.
• Global Integration & Compliance: Plan configuration requirements for a rolling global launch (including the EU and Japan), ensuring compliance with international data privacy regulations (e.g., GDPR, consent tracking, data deletion) and mapping integrations with external systems like CRM and safety databases.
• Validation & Testing Management: Oversee a rigorous, estimated 3-month validation phase, managing test scripts, IQ/OQ/PQ processes, and User Acceptance Testing (UAT)

Required Expertise and Qualifications

• Deep Medical Information Experience: Proven operational background in medical information workflows, staffing, and inquiry handling.
• System Implementation Expertise: Strong prior experience in managing, implementing, and configuring medical information databases. Familiarity with Veeva Med Inquiry and its specific architectural capabilities is highly preferred.
• SOP Writing: Demonstrated ability to audit existing operational processes and write clear, compliant internal SOPs for medical information systems.
• Validation Knowledge: Expertise in validating global IT systems that handle patient data and Adverse Events, with an understanding of global data privacy laws like GDPR.

The client mentioned that they are specifically seeking someone with strong Medical Information leadership and hands-on operational experience, ideally a former Medical Information Director or senior MI leader, who can:

• Provide oversight of medical information databases (eg, MEDINQUIRY)
• Lead and govern SOP development and optimization
• Bring deep understanding of end-to-end MI operations (beyond system PM)