Position: Clinical Education Specialist, Structural Intervention - NYC/New Jersey A dynamic organisation seeks an experienced Clinical Education Specialist, Structural Intervention - NYC/New Jersey to take on a multifaceted and impactful role. This is an opportunity to be part of a purpose-driven team reshaping industry standards and best practices. Key Deliverables and Responsibilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Develop SOPs, work instructions, and training materials for clinical operations teams. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Professional Requirements: Strong communication, presentation, and interpersonal skills across all organisational levels. Willingness to travel, adapt, and take on additional responsibilities as the business demands. Hands-on experience with tools, software, and platforms standard to the profession. A structured, results-driven approach with the ability to meet defined milestones consistently. 26 years of relevant industry experience with evidence of increasing responsibility. Demonstrated teamwork skills and the ability to build trust and rapport across functions. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We value talent and invest in our people this role offers both professional challenge and meaningful rewards.