Medical Affairs Associate

Dawar ConsultingSanta Monica, CA
Hybrid

About The Position

In this role, you will support expanded access programs, single-patient IND requests, and clinical study operations. You will coordinate program activities, manage timelines and documentation, communicate with investigators, sites, CROs, and vendors, and ensure compliance with regulatory and company requirements.

Requirements

  • BS/BA/RN in Life Sciences, Nursing, or related field
  • 3–5 years of clinical research, clinical operations, or medical affairs experience
  • Knowledge of ICH-GCP and clinical trial processes
  • Strong project coordination and communication skills

Nice To Haves

  • Oncology, hematology, or cell therapy experience preferred
  • Medidata RAVE/EDC experience is a plus

Responsibilities

  • Support Medical Affairs and clinical program activities
  • Coordinate expanded access and single-patient IND processes
  • Track study milestones, timelines, and deliverables
  • Manage vendor and CRO communications
  • Review study and regulatory documentation
  • Prepare status reports and support issue resolution
  • Collaborate with cross-functional teams and clinical sites

Benefits

  • Medical
  • Dental
  • Vision
  • Paid Sick Leave
  • 401K
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