• Provide customer education on the healthcare landscape to expand product adoption and customer retention. • Partner closely with US sales organization to deliver customer value messaging. • Present to various stakeholders, including physicians, hospital C-Suite, service line leadership, purchasing, prior authorization, and billing/coding staff. • Provide approved health economic education to the commercial sales organization. • Capture and record customer interactions to track touchpoint activity across multiple engagements. • Collaborate on corporate-initiated reimbursement strategies as needed. • Deliver market dynamics on customer insights, trends, and challenges learned from the field in cross departmental meetings and conference calls. • Manage travel and entertainment within the confines of the allowable budget. • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. • Maintain positive and cooperative communications and collaboration with employees, customers, contractors, and vendors. • Participate in regular, internal business unit meetings to influence and provide recommendations. • Adhere to corporate compliance programs and successfully participate in training and continuing education programs. • Ensure deliverables are accomplished on time and within budget.

• Define and execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant, robust, and fit for purpose. • Lead method transfer, validation, and lifecycle management activities, identifying opportunities for improvement and supporting post-approval changes. • Provide analytical leadership for PPQ, CPV, commercial manufacturing, and stability programs, ensuring reliable data, product quality, and regulatory compliance. • Review and approve analytical documentation, including protocols, reports, specifications, method validations, Certificates of Analysis, raw data, chromatographic integrations, and audit trails. • Oversee analytical execution at CDMOs, ensuring timely, compliant deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections. • Lead analytical investigations involving OOS/OOT results, deviations, complaints, and CAPAs, driving root cause determination and technical recommendations consistent with FDA and EU GMP expectations. • Assess analytical risks associated with manufacturing, supply chain, and process changes, ensuring appropriate impurity controls and lifecycle management strategies are maintained. • Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities. • Serve as the analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations and informed decision-making.

• Provide telephonic case management for Workers’ Compensation cases. • Assess medical appropriateness of treatment plans and coordinate services to optimize recovery and cost efficiency. • Develop, implement, and modify individualized case management care plans. • Perform ongoing clinical assessments and review medical records to ensure quality and timely care. • Identify and address barriers to recovery with proactive action planning. • Coordinate communication between injured workers, employers, providers, insurers, and other stakeholders. • Promote and document return-to-work capability at each medical milestone. • Ensure compliance with state-mandated treatment guidelines, nationally published protocols, and client requirements. • Track outcomes including patient satisfaction, return-to-work progress, and disability duration. • Utilize utilization review tools when indicated (pre-certification, concurrent review, retrospective review, medical director review). • Monitor provider and vendor performance to ensure quality and appropriate care delivery. • Maintain detailed and accurate documentation within the case management system. • Serve as a patient advocate while adhering to all legal, ethical, accreditation, and regulatory standards. • Participate in Quality Assurance, Grievance, or other committees as assigned. • Provide training or mentorship to claims staff or junior team members as appropriate. • Perform additional duties as assigned.

• Own the team’s shift to an agentic operating model across both Delivery and Quality Intelligence. • Lead the design and delivery of onboarding, upskill, and continuous learning programs across all support tiers and channels. • Lead a team of QA analysts focused on audit execution, model validation, and trend identification. • Build the QA-to-coaching routing, calibration cadence, and feedback frameworks. • Serve as the connective tissue between learning outcomes, quality signals, and business priorities. • Own the KPI framework across both teams and translate program activity into business impact.