Cytokinetics is hiring a
Associate Director

Summary

Cytokinetics is seeking an Associate Director for Regulatory Systems & Training to manage and maintain their regulatory affairs systems and tools. The role involves providing training, working with various departments, and identifying issues related to these systems. A broad range of experience in Regulatory Operations Disciplines is required, along with strong communication skills and organizational abilities.

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
• 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

Responsibilities

• Develop, maintain, and deliver regulatory systems and tools-focused training to all Cytokinetics stakeholders in the regulatory submission process
• Work with Regulatory Affairs leadership and members of Cytokinetics R&D functions to roll out document management/RIM/other processes across the organization
• Serve as the business administrator for Regulatory Affairs systems, performing tasks such as object and data dictionary creation/updates
• Identify and escalate functionality, useability, and other issues related to regulatory systems to Regulatory Operations leadership and IT
• Work with management, IT, QA, and vendors on data/document migration activities
• Assist in the development, and execution of test scripts for implementation and updates/upgrades to validated systems
• As needed, provide 1:1 training and support to new users of Cytokinetics Regulatory systems
• As needed, participate in cross-functional and Regulatory-centric process improvement initiatives
• During times of peak workload, may assist other Regulatory Operations functions with submission preparation, publishing, and QC tasks
• Monitor emerging trends and best practices with respect to regulatory systems and their use, and provides recommendations to continuously improve the use of Cytokinetics’s regulatory systems and management of regulatory information
• Manage consultants/vendors (e.g., supporting system configuration, data migration, training development), as needed