Medical Affairs Associate

Hi, Job role:

Medical Affairs Associate Location:

Santa Monica / El Segundo, CA - Onsite/Hybrid Role Overview This role supports Medical Affairs activities related to expanded access programs, out-of-specification case support, and single-patient IND processes. The individual contributes to operational execution of treatment-use and clinical support activities by coordinating program deliverables, managing vendors, supporting site/investigator communications, and ensuring alignment with applicable regulations and internal procedures. Key Responsibilities Review study-related and start-up documents (protocols, ICFs, investigator brochures, pharmacy manuals, monitoring plans, CRFs, etc.) as delegated Manage assigned components of clinical studies and expanded access activities as part of the study team Coordinate timelines, documentation, communications, and cross-functional follow-up for OOS programs, EAPs, and single-patient IND requests Manage vendors and CROs - communicate timelines, oversee obligations, and ensure performance expectations are met Attend team meetings to support planning, issue resolution, and program execution Provide training at investigator meetings, site initiation visits, and teleconferences as needed Create and review site feasibility assessments Track key deliverables: screening, enrollment, data flow, protocol deviations, and program milestones Proactively identify risks, recommend solutions, and escalate appropriately Prepare metrics and status updates for management review Support resolution of clinical trial queries for interim, primary analyses, and final database locks Draft site newsletters and correspondence including best practices and FAQs Resolve routine queries from clinical sites and stakeholders per ICH Google Cloud Platform and protocol requirements Apply standard medical and scientific terminology in documentation and communications Basic Qualifications

BS / BA / RN

in Nursing, Science, or a health-related field 3-5 years of related experience Preferred Qualifications Oncology / Hematology experience; Cellular Therapy is a plus Experience with iMedidata/RAVE EDC Study start-up experience from site-based, CRO, or sponsor role Working knowledge of transplant patient care and apheresis collection Strong analytical, organizational, and communication skills Ability to manage competing priorities in a fast-paced environment