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Eisai Open Job Positions
Aseptic Mechanic
Research Triangle Park (RTP),
North Carolina
Job First Active on:
DIVISION: Eisai -
The Aseptic Mechanic must have a minimum of three years experience in the operation of equipment
associated with parenteral manufacturing. The Aseptic Mechanic will have a minimum of 1 year
experience performing Preventative Maintenance on parenteral manufacturing equipment. Additionally,
experience with sterile gowning is preferred. A minimum of a high school diploma is required, Associate's
degr ..
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Associate Director Director - Regulatory Affairs
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
The incumbent will be responsible for developing and guiding the global regulatory strategy for assigned products, and serve as the core global regulatory representative on International Project Teams for assigned products and provide regulatory leadership.
Other responsibilities include (burt are not limited to):
Supervising the preparation of global regulatory submissions, and serving as the p ..
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Associate Director Director CMC Regulatory Affairs
Exton,
Pennsylvania
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DIVISION: Eisai -
Conduct CMC related business for aquisition of approvals by understanding EPCS (Eisai Product Creation Systems)objectives based on corporate policy and management strategy.
Responsibilities include (but are not limited to);
Establishing strategy and planning for CMC on submission of marketing approvals (BLA, NDA)
Acquire CMC related information globally for market application and development
Pla ..
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Associate Director, Clinical Operations
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
The Associate Director, Clinical Operations will function as a group leader for the Clinical Study Managers within Medical Affairs, Oncology and Institutional Care and is accountable for assigned programs and staff, reporting directly to the Director of Clinical Operations and Project Management.
To provide the technical, content and management expertise to lead teams and complex studies executed ..
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Associate Director, Marketing, AcipHex
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
The Associate Director Marketing for AcipHex will have primary responsibility for the daily brand operations and will be the lead on the AcipHex ER launch. This person understands resource allocation needs and appropriately aligns those resources to support strategy and drive results. The Associate Director must have the competency to partner cross-functionally with diverse business leaders and dr ..
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Associate Director, Project Management, Frontier
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
In association with the International Project Team Leader (IPTL), serves as Project Manager and manages the development of one or more compounds from candidate selection to NDA/MAA filing, in accordance with agreed development plans and corporate objectives.
1.Institutes and maintains overall International Project Team (IPT) organization, coordination and management.
2.Ensures optimal communicati ..
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Associate Manager,Technical Operations
Research Triangle Park (RTP),
North Carolina
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DIVISION: Eisai -
To provide support to the primary Manufacturing activities. This includes research and documentation of deviation investigations, implementation of Continuous Quality Improvement Management processes, improvement projects, improvement of manufacturing operation efficiencies through measurement systems and the implementation of competency training and development for manufacturing staff. Lead trans ..
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Associate Senior Counsel Shared Services
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
This mid-level attorney's role is to assist in the management of the legal affairs of the US Eisai organizations, risks and opportunities in a proactive and collaborative manner, and in the achievement of Eisai's business strategies and overall mission. The focus will be primarily on legal matters impacting the clinical research arms of the US Eisai organizations(s) and related functions such as R ..
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Clinical Study Manager
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
The Study Manager will be accountable for the overall management of clinical studies in late phase development. This position is essential to the successful operational execution of clinical studies conducted by Eisai Medical Affairs Oncology & Institutional Care. Successful execution of the responsibilities envisaged by this position will result in timely completion of high-quality, within-budget ..
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Dir, Global Reg Sys Clinical
Woodcliff Lake,
New Jersey
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DIVISION: Eisai -
Main purpose of the job:
The purpose for this role is represented through functional work in 4 areas: Business Process Re-engineering Information Technology, Regulatory Affairs and Project Management,.
Business Re-engineering: To work closely with the Clinical Organisation to understand their process and system needs as they relate to Regulatory Affairs. This will be achieved by acting as an inte ..
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