Jobs at Orca Biotech

Manage end-to-end onboarding for East Coast commercial treatment sites, coordinating internal teams, conducting assessments and audits, ensuring quality and regulatory compliance, training partners, tracking milestones, resolving issues, maintaining documentation, and improving onboarding processes through stakeholder feedback.

Coordinates commercial marketing operations and Medical, Legal, and Regulatory review processes for biotech promotional materials. Manages conferences, campaigns, agencies, vendors, marketing assets, project timelines, and budgets. Facilitates PRC/MRC meetings, administers Veeva PromoMats workflows, performs submission quality checks, tracks material approvals and expirations, and supports FDA Form 2253 submissions while ensuring compliance with applicable regulations.

Lead payer market access across the Southeast for Orca Bio’s cell therapy products. Develop payer strategies, secure favorable coverage and reimbursement, support treatment-center onboarding, address patient access issues, and build relationships with commercial, Medicare, Medicaid, hospital, and health-system stakeholders. Present clinical and economic value propositions, maintain payer policies, track market access KPIs, and collaborate with Sales, Medical Affairs, Legal, Quality, Marketing, and Case Management. Travel is approximately 40%.

Monitor clinical studies at investigative sites or remotely, ensuring protocol, ICH-GCP, SOP, and regulatory compliance. Responsibilities include site monitoring visits, source data verification, medical record and adverse event review, site staff support, monitoring report authoring, trial material development, SOP contributions, and eTMF documentation. The role requires CRA experience, preferably in oncology, hematology, or cell and gene therapy, plus proficiency with clinical trial systems and regulatory requirements.