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