Eisai, Inc Hiring for Senior Associate, Global Regulatory Systems – Onsite in Nutley, NJ job in Nutley 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.

Provide support, strategies and business solutions for the development and maintenance of Eisai regulatory systems. Establish, manage, and support regulatory systems according to the system requirements and develop regulatory requirement and business and system support processes. Ensure the integrity of the data either managed within the system or migrated from legacy systems, utilizing Quality Control processes and training end users for key tasks within the managed system. Maintain the data integrity of data within the regulatory systems. Ensure that Regulatory Information Systems are supported and managed according to business need and regulatory compliance. Capture and implement system enhancements to optimize their operational capabilities according to business need. Develop user requirements specifications for future information systems and create business justification for new systems, Initiate UAT Scripts. Deployment of software, design and deliver training systems accordingly. Stay current with industry best practice and software regarding Regulatory Information Management, identifies opportunities to shorten approval timelines through enhanced knowledge sharing. Engage with vendors and internal partners to drive future state of the shelf software package. Ensure completeness of content contained in information management systems specifically as it relates to compliance. REQUIRES Bachelor’s degree (or foreign equivalent) in Pharmacy, Pharmacology, Drug Regulatory Affairs, or closely related life science discipline plus 2 years of experience with Document Management Systems in job offered or as Senior/ Regulatory Affairs Associate/Officer. Also requires 2 years of experience with/using the following (which may have been obtained concurrently): Regulatory Information Management systems supporting regulatory information or publishing tool., QC processes, Data Integrity and Data Quality Standards Processes, UAT Scripts , Mapping User Requirements to Functional Specification. Send resumes to HR Department, Job Code: R3266, Eisai Inc., 200 Metro Blvd., Nutley, NJ 07110.

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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