Empowering Muscle Empowering Lives
Heart Failure • Amyotrophic Lateral Sclerosis • Hypertrophic Cardiomyopathy
August 14
🏡 Remote – New York
Empowering Muscle Empowering Lives
Heart Failure • Amyotrophic Lateral Sclerosis • Hypertrophic Cardiomyopathy
• Cytokinetics is seeking an Associate Director, Regulatory Systems & Training to support implementation, maintenance/upgrades, and usage of Regulatory Affairs systems and tools including EDMS, RIM Systems, publishing systems, and authoring templates. • This role will serve as the business administrator for Cytokinetics’s EDMS, RIM, and publishing systems, and support the development, validation, and day-to-day use/troubleshooting of Regulatory systems.
• Broad range of experience across various Regulatory Operations Disciplines: including document formatting/publishing, submission publishing, EDMS system use, RIM system use (8+ years) • Proven track record of working with management, business stakeholders, vendors, IT, and QA to develop, deliver, and maintain regulatory systems-focused training • Previous experience supporting regulatory systems implementations and usage required • Previous experience supporting CSV activities preferred • Strong written and verbal communication skills • Ability to deliver system use training via in-person and virtual (e.g., Zoom) sessions • Strong organizational skills • Analytical and problem-solving skills and ability to identify process and technical issues requiring escalation • Bachelor’s degree required
Apply Now