Cytokinetics
Associate Director, Regulatory Systems and Training
Cytokinetics, Radnor, Indiana, United States,
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
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 will 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.
This position is located onsite in Radnor, PA.
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, usability, 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
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
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
#J-18808-Ljbffr
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 will 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.
This position is located onsite in Radnor, PA.
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, usability, 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
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
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
#J-18808-Ljbffr