Associate Director - Regulatory Systems and Training

August 14

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Cytokinetics

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Empowering Muscle Empowering Lives

Heart Failure • Amyotrophic Lateral Sclerosis • Hypertrophic Cardiomyopathy

201 - 500

💰 $450M Post-IPO Debt on 2022-06

Description

• 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.

Requirements

• 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