EISEISUS Looking for Safety Application Manager at Nutley, NJ Full Time

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world’s most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Analyzes business and technical processes to formulate and develop new and modified business

information processing systems. Develops, maintains, and establishes operational specifications for

systems considering such things as information flow, volume, ad hoc reporting, analysis and document

format. Represents the business unit to define requirements and business cases for the technology

developments. Coordinates with business and technology teams ascertaining system requirements, such

as program functions, output requirements, input data acquisition, execution of users acceptance and may

coordinate testing, and system techniques and controls. Requires knowledge of computer system

capabilities, business processes, and workflow.

Job Summary

The Application Manager (Safety) is responsible for ensuring the ongoing support, maintenance, and

system administration of business-critical Safety and Clinical Pharmacology solutions that support Eisai’s day to day business operations. Key, strategic business groups rely on the integrity, security, reliability, and health of these solutions for their ongoing global clinical studies.

Reporting to the Associate Director, IT Operations, the Application Manager’s primary responsibilities

consist of application support and change management, system administration, SaaS oversight, and

communications leadership across cross-geographical support teams. Management responsibilities include

overseeing support tickets, issues resolution, and application change management to deliver timely, well-coordinated

operations support. This leader also oversees system health monitoring to ensure compliance

with Eisai policies, procedures, and Good Clinical Practice (GCP) regulations.

The Application Manager(Safety) will lead a cross-functional support team of shared resources from the Eisai IT

organization and Cloud providers involved in the support, maintenance, and optimization of Safety and Clinical Pharmacology solutions.

Essential Functions

Application Support:

• Is accountable for ensuring the timely handling and resolution of issues, incidents, and requests.
• Coordinates, monitors, and oversees support activity on a daily basis.
• Escalates major incidents within the IT organization or Cloud provider in a timely manner.
• Communicates support status to appropriate stakeholders on a regular basis.

System Administration:

• Ensures the administration of applications is conducted as defined in the System Maintenance Manual.
• Partners with Business Owners and System Administrators to plan and deliver non‑functional changes such as meta-data and reference data updates.
• Ensures user access provisioning meets or exceeds service-level agreements (SLAs) and is also conducted in compliance with procedures.
• Ensures the system performs as expected across all applicable geographies.

Change Management:

• Plans and delivers functional changes to address unmet business needs and fix bugs.
• Collaborates with IT Business Relationship Managers (BRMs), Business Owners, and other stakeholders to plan roadmaps or functional changes.

Oversight of SaaS Providers:

• Oversees the system and support performance of Eisai’s SaaS providers.
• Partners with SaaS providers to plan maintenance and product releases.
• Partners with IT BRMs to review licenses and budget forecasts.

Audit Support:

• Partners with IT Quality Assurance and Compliance teams to prepare for and support internal and external audits.
• Leads reviews of all system validation deliverables and access management logs and conducts periodic reviews of user access management for clinical systems.

Requirements

Work Experience and Education:

• Bachelor’s Degree in the field of computer science, information science, management information systems, or business administration or equivalent experience relevant to this position.
• Minimum of 5 years experience in helpdesk/application support (includes 1 to 2 years managing complex applications).
• Minimum 2 years of Pharma experience preferably in GxP environment.
• Experience supporting global applications and working with cross geographical helpdesk teams.

IT Experience:

• Strong understanding of support processes based on ITIL principles.
• Solid understanding of SDLC and system lifecycle management.
• Solid understanding of helpdesk solutions such as ServiceNow, Zendesk.

Leadership and Teamwork:

Ability to lead diverse, cross-functional teams involved in business-critical system maintenance activities and issues resolution. Teams involved include technical Subject Matter Experts (SMEs), vendor support members, and Infrastructure teams.

Communication, Organization and Issues Resolution Skills:

• Excellent interpersonal and communication skills. Influential networker with a collaborative mindset and strong customer-centric focus.
• Ability to plan, organize, prioritize, and work effectively in a fast paced and dynamic environment.
• Proven problem solver who takes ownership and is driven by a strong sense of exigency, timely resolution, and keen attention to detail to execute successfully under time and resource demands.

Eisai Core Values:

Embodies and consistently demonstrates Eisai’s core company values: Quality, Teamwork, Respect, Integrity, and Professionalism.

Geographical:

• Position based in Nutley, NJ
• Global Application Manager for Safety systems such as LSMV and Metworks

Is responsible for oversight of support tickets, issue resolution, application change management, monitoring of system health, and ensuring applications comply with Eisai policies, procedures and GCP regulations

Business Units:

• ADBL, DHBL, PV

Financial and Organizational

• Leads contingent workforce of 3 to 5 from Managed Service Provider and/or Vendor Technology Platforms

Applications:

• Pharmacovigilance and Clinical Pharmacology solutions such as LSMV, SRA BO and Metwork
• IT tools such as ServiceNow, ValGenesis
• Collaboration tools such as Microsoft Teams, SharePoint, JIRA, Azure, DevOps
• Data Integration, ETL, and Visualization tools

Desktop:

• Office Productivity tools
• Remote Desktop
• DocuSign

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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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