Senior Manager, Patient Access Operations
TakedaAbout the role
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Job Description
Job Summary
The Senior Manager, Patient Services Operations (Free Goods Programs) is responsible for the strategic and operational oversight of the company’s Free Commercial Goods, Trial, and Product Replacement programs within Patient Services. This role ensures compliant, efficient, and patient‑centric delivery of free product to eligible patients while maintaining rigorous operational controls, regulatory adherence, and strong vendor performance.
This position owns end‑to‑end operational execution, serves as the primary operational lead for pharmacy and hub partners, and plays a critical role in balancing patient access, compliance obligations, operational excellence, and financial stewardship.
Key Responsibilities
Free Goods & Patient Assistance Program Operations
Own day‑to‑day and end‑to‑end operations for Free Commercial Goods programs, including free trials, PAP‑related operations, product replacement, renewals, and discontinuations.
Ensure programs operate in alignment with company policy and applicable legal and regulatory requirements, including government payer exclusions and patient eligibility rules.
Develop, maintain, and enforce SOPs and work instructions governing free goods and PAP operations.
Resolve complex patient, provider, and pharmacy escalations across the free goods and PAP portfolio.
Contract, Vendor & Relationship Management
Serve as the primary operational point of contact between the company and dispensing pharmacy partners as well as hub vendors and service partners.
Manage multiple vendor interdependencies across specialty pharmacy, hub, and support partners.
Own operational management of Master Service Agreements (MSAs), Statements of Work (SOWs), SLAs, KPIs, and performance commitments.
Lead annual contract and SOW reviews, including negotiation of free commercial, trial, and PAP services.
Conduct regular business reviews (monthly, quarterly, annual) and verify accuracy of vendor reporting and presentations.
Address service failures, disputes, and performance gaps, issuing corrective action plans as needed.
Performance Monitoring & KPI Management
Monitor and report on KPIs including order accuracy, shipping turnaround times, inventory accuracy, returns processing, cold‑chain compliance, call‑center performance (if applicable), and patient service metrics.
Lead root‑cause analyses and ensure implementation of corrective and preventive actions (CAPAs) when performance trends fall below expectations.
Drive accountability and continuous performance improvement with vendors.
Quality, Regulatory & Compliance Oversight
Ensure pharmacy and vendor compliance with FDA regulations, DSCSA requirements, state pharmacy laws, and internal quality standards.
Review, approve, and maintain SOPs related to product handling, storage, dispensing, packaging, and shipping.
Manage quality incidents including temperature excursions, mis‑shipments, product complaints, quarantines, and adverse event reporting workflows.
Lead and participate in recurring quality reviews, call calibrations, scorecard evaluations, and corrective action follow‑up.
Inventory & Supply Chain Oversight
Oversee free goods inventory management, including forecasting, replenishment, cycle counts, shrinkage, expiry management, and safety stock levels.
Partner with internal Supply Chain teams and external partners (e.g., Americares) to ensure uninterrupted product availability.
Provide ad‑hoc operational support during low‑stock or stock‑out situations.
Manage supplies ordering, kitting, and troubleshooting when procurement challenges arise.
Oversee quarantine reviews, investigations, approvals, and compliant product destruction or returns.
Financial & Budget Management
Review and validate monthly pharmacy and vendor invoices.
Investigate billing discrepancies, overc
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