Associate Director, Regulatory Systems and Training

Role Overview

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 with be responsible for working closely with leadership and colleagues in Regulatory Affairs, IT, and QA, as well as vendors/consultants to develop, maintain, and deliver regulatory systems training across the organization.  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.

Responsibilities

• With oversight from the Head of Regulatory Operations & Submission Management, and in partnership with IT and QA, 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 (e.g., Publishing, Submission Management) 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

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• 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

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do –all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer