Medical Affairs - II*

Job Description: Seeking a Medical Affairs Associate to support expanded access programs, out-of-specification (OOS) programs, and single-patient IND processes. This role supports clinical operations and treatment-use activities through study coordination, vendor management, site communications, and clinical program execution. Support clinical trials and expanded access programs from study start-up through closeout. Coordinate study-related documentation, timelines, milestones, and deliverables for expanded access and single-patient IND requests. Review clinical study documents, including protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, and case report forms. Manage CROs, vendors, and external partners to ensure timely execution of assigned activities. Coordinate site feasibility assessments, investigator communications, and site-specific activities. Track screening, enrollment, data flow, protocol deviations, and other clinical program milestones. Identify program risks, support issue resolution, and upscale operational challenges. Prepare program metrics, status reports, site newsletters, and clinical study communications. Support clinical data queries, interim analyses, and final database lock activities. Ensure compliance with ICH-GCP, clinical study protocols, and applicable regulatory requirements. Education Bachelor's degree in Nursing, Life Sciences, or a related healthcare/scientific discipline preferred. Associate degree with an active RN license may be considered. RN candidates with relevant clinical operations experience are encouraged to apply.