The Manager, Quality will lead the end-to-end onboarding process for commercial sites, ensuring all activities align with company quality standards and operational goals. They will coordinate with internal teams and external partners to facilitate seamless transitions while conducting site assessments and audits to ensure regulatory compliance.
The National Senior Director of Field Medical Affairs will lead and evolve the national MSL team, defining operational frameworks and ensuring the execution of medical strategies. This role involves strategic engagement with key opinion leaders, oversight of clinical trial support, and cross-functional collaboration to align field activities with organizational goals.
The coordinator will manage commercial marketing projects, including conference logistics and campaign workflows, while serving as the operational lead for the MLR review process. They will ensure all promotional materials are compliant, accurate, and effectively managed within Veeva Vault PromoMats.
The Medical Science Liaison will foster relationships with key opinion leaders and support the scientific strategy for next-generation cell therapies. They will also serve as a subject matter expert, providing clinical insights and supporting investigator-sponsored trials within the designated territory.
Develop and execute payer strategies with commercial, national, regional, Medicare, and Medicaid accounts to secure favorable coverage, reimbursement, and patient access for Orca Bio products. Serve as the payer-access contact for authorized treatment centers, support onboarding and hospital partnerships, resolve access issues, and track account performance.
The Senior Director will lead the U.S. Payer Account Director team to expand patient access and remove reimbursement barriers for TREGZI. They are responsible for developing market engagement strategies, managing pricing and contracting, and integrating market access insights into commercialization plans.
The Director will own the strategy, buildout, and day-to-day operation of the distribution channel, managing 3PL partners and specialty pharmacy networks. They will ensure end-to-end distribution and order-to-cash pathways are compliant and efficient to support patient care.
The Clinical Research Associate is responsible for monitoring clinical studies at investigative sites or remotely to ensure compliance with protocols, SOPs, and regulatory requirements. They will perform source documentation verification, review patient data, and provide support to site staff to ensure accurate reporting.
The Director/Head of Pharmacovigilance will lead the safety function, providing operational oversight and guidance to a dedicated team. They are responsible for managing risk mitigation activities, ensuring regulatory compliance, and representing product safety in cross-functional environments.
The Medical Science Liaison will foster relationships with key opinion leaders and support the scientific strategy for next-generation cell therapies. They will serve as a subject matter expert, providing clinical insights and managing scientific exchanges within the designated territory.
The Director of Case Management will lead the daily operations of the national case management function, ensuring efficient and empathetic coordination for TREGZI therapy. They will also collaborate with leadership to scale the customer service model, refine workflows, and manage team performance.
The associate is responsible for reviewing adverse events, determining regulatory reporting requirements, and managing safety database entries. They also serve as a liaison between internal teams and external vendors to ensure accurate and timely safety reporting.
The Senior Specialist will implement and maintain the global Quality Management System across all sites, including managing internal audits and supplier programs. They will also lead inspection readiness activities and collaborate with cross-functional teams to ensure compliance with GxP and regulatory standards.
