Quality Associate I, II, III, Senior (San Diego, CA) Quality Eisai Inc. -- San Diego, CA (1) Job Description * Performs a wide variety of activities to ensure safe product * Activites include, but are not limited to: conducting audits, administering training programs, data and documentation reviews and analysis and, ultimately, product disposition - all in compliance with applicable regulatory req

Planner/Scheduler Production Planning Eisai Inc. -- Ridgefield Park, New Jersey Job Description * This position will support manufacturing and packaging activities by: developing the most efficient schedules to meet the production demand-plan, minimize machine/line set-ups, and changeovers, and ensure material availability; establishing the priority plan for Manufacturing and Packaging; maintainin

Manager/Senior Manager, Clinical Quality Assurance Quality Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * The Manager/Senior Manager of Clinical Quality Assurance defines and implements procedures to assure that all activities subject to regulatory review and conducted within Eisai, Inc. comply with internal, International and U.S. domestic standards and guidelines. This position will

Information Technology Senior Validation Specialist Quality Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Responsible for managing and coordinating all validation activities for multiple IT projects. The person in this position will be responsible for writing validation plans, protocols and reports, reviewing validation and technical documents, executing protocols and preparing valida

Sr. Analyst, SAP FI/CO Finance, Information Technology and Administration Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * The Senior Analyst SAP FI/CO will provide leadership in process analysis, process and system design, systems development and configuration, as required to support the SAP system for Management Accounting and Product Costing Processes * As the SAP FICO expert, the pos

Manager, Clinical Quality Assurance (EGC) Clinical Quality Assurance Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Supervise and/or perform quality assurance audits of clinical documents (e.g., clinical study reports, investigator brochures, etc.) to assure compliance with ICH guidelines, company standards and Good Clinical Practice * A second major responsibility wi

Manufacturing Maintenance Mechanic Manufacturing Eisai Inc. -- Research Triangle Park, North Carolina Job Description * Provide support to the Manufacturing Department and to ensure that all equipment is in safe and optimal working condition * This position requires a self motivated individual with good work ethics * Basic mechanical, electrical and hydraulic troubleshooting skills * Working knowl

Senior Director/Director of Translational Medicine - Biostatistics (EGC) Biostatistics Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * This position will be responsible for leading the statistical strategy in support of early clinical development goals * This will include the defining of the PK profile, establishment of maximum tolerated dose, confirmation of pharmacol

Senior Clinical Research Scientist, CNS I (EGC) Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * The incumbent is responsible for, but not limited to assisting the Clinical Leader in the planning, implementation, managing, and reporting of clinical trials but may serve as Clinical Leader for selected trials * Preparing clinical trial synopses and clini

Associate Director, Postmarketing Regulatory Affairs (EGC) Regulatory Affairs Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * The incumbent will be responsible for, but not limited to providing regulatory input into strategic marketing initiatives and ESI policies regarding advertising and promotional activities * Reviewing and approval of all advertising and promotion

Manager, Forecasting Sales & Marketing Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Responsibilities include building a strong business alignment with internal customers and provide key internal customers with market/product specific forecasts and analytics to support decision-making * Developing and implementing a systematic approach to create a market-based and event-driven forecas

Product Manager, Aciphex Marketing Sales and Marketing Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Tactical implementation of professional and consumer marketing programs * Assist in development of product business plan * Run POA meetings and ensure its tactical implementation * Commercial chair for secondary publications committee meetings * Create and maintain relationships with k

Manager/Sr. Manager, Medical Education & Investigator Initiated Study Grants Medical Affairs & Services Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Manage the Eisai Medical Education and Investigator Initiated Study Grant Function * Manage the actvities of the Grants Coordinator * Primary interface with internal stakeholders, external investigators and educational grant requestors *

Supervisor, Production Planning Purchasing & Planning Eisai Inc. -- Research Triangle Park, North Carolina Job Description * Develop and maintain the production plan for 2 major pharmaceutical products (16 SKU's) in order to prevent backorders and ensure an uninterrupted supply of product to our customers * Maintain inventory levels for finished good, bulk tablets, and active ingredient to maxmize

Associate Director, Project Management - Oncology (EGC) Global Project Management Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Assist in the global development of oncology compounds * Interface with the oncology TA, IPTLs and global team members in clinical, clinical operations, regulatory affairs, data management, statistics, finance, and medical writing and throug

Senior Director, Clinical Operations (revised) (EGC) Clinical Operations Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Accountable for providing direction and oversight of the Clinical Operations department which includes; therapeutically aligned Directors and Associate Directors, RDDC & QC (within Clinical Operations) including aspects of eDMS, Clinical Drug Supplie

Senior Clinical Research Scientist, Oncology (EGC) Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Assist the Clinical Leader in the planning, implementation, managing, and reporting of clinical trials but may serve as Clinical Leader for selected trials * Prepare linical trial Synopses and clinical trial Protocols. Prepares patient SAE narratives, se

Senior Clinical Research Scientist, CNS 2 (EGC) Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Assist the Clinical Leader in the planning, implementation, managing, and reporting of clinical trials but may serve as Clinical Leader for selected trials * Prepare clinical trial Synopses and clinical trial Protocols. Prepares patient SAE narratives, sect

Associate Manager/Manager - Clinical Operations - SHKA-ER (EGC) Clinical Operations Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Responsible for ensuring that the therapeutic area is meeting EGC's short- and long-term goals with respect to monitoring/management of clinical trials in the SHKA-ER clinical operations group * Must have the technical capabilities and exp

Manager of Clinical Operations - CNS (EGC) Clinical Operations Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Responsible for independently managing and/or supervising management of all aspects of clinical trials (phase I-III) * Management of CROs and other vendors, liaising between Eisai upper management & CROs, and acting as a Clinical Operations leader for project

Manager/Senior Manager - Clinical Quality Assurance (EGC) Clinical Quality Assurance Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Coordinate and perform audits of clinical investigator sites and clinical vendors to support Medical Affairs' Phase 4 clinical research programs at ESI - Woodcliff Lake * Provide guidance to clinical personnel at ESI, to ensure that resea

Clinical Data Manager - CNS (EGC) Data Management Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Participate on teams in support of CNS project goals and objectives * Reviewing protocols, supervising CRF development, and monitoring database design * Supervising data management activities of CROs or in-house, as applicable Responsible for query generation and resolutio

Manager, Clinical Operations (EGC) Clinical Operations Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Responsible for independently managing and/or supervising management of all aspects of clinical trials (Phase I-III), including management of CRO and other vendors, liaising between Eisai upper management and CROs, and acting as Clinical Operations leader for project

Senior Manager, Data Management AI/GI (EGC) Data Management Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Responsible for the data management team within the AI/GI therapeutic area, as well as leading and participating on teams in support of project goals/objectives * Managing Senior Clinical Data Managers and providing performance evaluations Supporting data managem

Counsel R&D : EMR & Morphotek Support Legal Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Providing advice and counsel on a day to day and project basis on various legal maters including federal and state laws pertinent to Eisai's R&D, drug safety and related activities, FDA regulations, contractual relations, fraud & abuse/antikickback and related statues, product l

Financial Analyst, TMI & G&A Admin Finance & Administration Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Responsible for the administration and maintenance of the financial reporting system (TMI) * Responsible for the budgeting and forecasting of expenses in the G&A Administration departments * Will assist the Senior Manager, Budgeting & Forecasting with internal reporting of P&Ls, b

Associate Director, Sales Administration Sales & Marketing Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Responsible for the overall planning, organizing and operations of sales administration functions including sample compliance, incentive compensation, sample warehousing and distribution and creating and controlling costs related to all of these functions * Responsible for the acco

Director, Biostatistics (Oncology) (EGC) Biostatistics Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Directing the biostatistics strategy and contributing to its outcome within a specific area of responsibility * Assuming accountability for analysis for clinical trials/clinical development plans across EGC multiple therapeutic areas and worldwide locations, potential

Associate Director/Director, Corporate Communications (EGC) Corporate Planning Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Leading all aspects of internal strategic communications for EGC to support the implementation of key business objectives and initiatives * Collaborating with company leadership to manage the company's strategic communication efforts * Translat

Manager Global Market Research Global Medical & Marketing Services Eisai Corporation of North America -- Woodcliff Lake, New Jersey Job Description * Support the Global Brand Teams in all aspects of Branding, Positioning, and Messaging, etc. * Partner with Global Health Economics and Outcomes Research to conduct research on pricing and reimbursement in major launch markets * Partner with all globa

Product Manager, Fragmin Marketing Sales & Marketing Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Responsible for building and executing plans to expand the appropriate use of Fragmin in the oncology setting * Will build tools to assist reps in hospital settings * Responsible for driving advertising and promotion tactics specific to the extended treatment indication * Responsible for

Director, Biostatistics (Oncology) (EGC) Biostatistics Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Direct the biostatistics strategy and contributing to its outcome within a specific area of responsibility * Assume accountability for analysis for clinical trials/clinical development plans across EGC multiple therapeutic areas and worldwide locations, potentially ha

Senior Administrative Coordinator Sales & Marketing Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Provides overall administrative support to the Vice President of Sales * Responsible for maintaining calendar updates, travel arrangements and scheduling meetings as required and facilitating the overall coordination of the executive's activities * Job responsibilities may include various

Microbiologist III or IV PAR&D Eisai Inc. -- Research Triangle Park, North Carolina Job Description * Review and conduct microbiological methods and organize testing activities and GMP systems required to support quality control of manufactured product and clinical supplies * Perform all microbiological analyses and possess theoretical knowledge of the scientific methodologies employed. Train anal

Senior Manager, Human Resources (EGC) Human Resources Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Primary focus on establishing and growing business partnering relationships with specified client groups to ensure that all opportunities for identifying and developing talent and related support systems are realized in support of business objectives * Will partner wit

Associate Director/Senior Manager, Drug Regulatory Affairs CMC (ECG-US) Regulatory Affairs Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Position location may be in Ridgefield Park, NJ or Research Triangle Park, NC * Support commercial and corporate marketed products initiatives * Development of CMC dossiers and registration strategies in support of commercial object

Director/Senior Director, Imaging (EGC) Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Lead development (in conjunction with clinical teams, Imaging Group and external imaging KOLs) and imaging biomarker strategy for PoC as well as compound profiling and registration trial endpoints * Interface with preclinical groups to develop possible tracers for

Clinical Operations Financial Associate (revised (EGC) ) Clinical Operations Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Will work with all the Clinical Operations leads to understand the day-to-day activity of all clinical trials while supporting the Finance and Grants & Contracts Departments with the interpretation of all operational activity * Liaise with the Fi

eDMS System Specialist (EGC) Information Technology Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * The Documentum based electronic Document Management System (eDMS) System Administrator is responsible for the day-to-day support of eDMS for the entire US region including EMR, ESI, RTP, and ERI * This position serves as the first line of eDMS User Support and is respons

Associate Vice President - Global Therapeutic Area Head, Oncology (EGC) Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Build an effective Oncology area to achieve business objectives * Provide input and support Oncology business strategy with an enterprise-wide perspective and contribute to its outcome * Responsible for organization and successful op

SAP Financial Analyst Finance, Information Technology and Administration Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * The SAP Financial Analyst will provide leadership in process analysis, process and system design, systems development and configuration, as required to support the SAP system for Financial Accounting (including general ledger, accounts payable fixed assets and closing

Senior Analyst, IT Compliance and Administration Finance, Information Technology & Administration (FITA) Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Create, mange and lead the IT compliance program, which involves the creation, periodic review and updating of IT compliance documentation including Standard Operating Procedures (SOP's), supporting procedures, IT inventory databases, I

Director/Senior Director, Oncology (EGC) Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Assuming (Global) leadership for one or more Oncology area programs * Defining Oncology/project vision and strategy for achieving that vision, and engaging and motivating teams to buy into that vision and execute strategy through clear and persuasive communication

Associate Director/Director, Sepsis and Anti-Infectives Therapeutic Areas Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Primary focus on infectious disease * Support of the Sepsis/AI area function and strategy * Lead problem solving across the Sepsis/AI area with an enterprise-wide perspective; facilitating team(s) to identify issues and propose solutions * Contribut

Medicaid Rebates/Government Membership Analyst Government Pricing and Contracting Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * Responsible for the Medicaid Drug Rebates Process which includes, but not limited to, Medicaid/SPAPs/Supplemental Rebate processing within the time allotted by CMS; coordinating check requisition packages and approvals; coordinating the timely issuance of che

Associate Director - Clinical Operations (Frontier) (EGC) Clinical Operations Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Technical and content expertise to lead multiple teams and/or studies within the Clinical Operations Group * Sound knowledge of the entire drug development process, including clinical plan development, study areas and execution of the entire cli

Associate Senior Counsel (Business Development/Licensing & R&D) Legal Eisai Inc. -- Ridgefield Park, New Jersey Job Description * Provide advice and counsel to Eisai's participatiion in due diligence, deal structuring activities, coordination among disciplines and legal counsel, negotiation, drafting and management of outside counsel on deals, and assisting with the transitioning and integration o

Associate Senior Counsel (R&D:EMR & Morphotek support) Legal Eisai Inc. -- Ridgefield Park, New Jersey Job Description * Provide advice and counsel various legal maters including federal and state laws pertinent to Eisai's R&D, drug safety and related activities, FDA regulations, contractual relations, fraud & abuse/antikickback and related statues, product liability and other liability matters, h

Product Manager Sales & Marketing Eisai Inc. -- Woodcliff Lake, New Jersey Job Description * As a key member of the AcipHex marketing team, this person is responsible for the strategic development and tactical implementation of professional marketing programs designed to drive brand share and increase prescription volume, contributing to achievement of the brand business plan * Responsible for bot

Associate Director/Senior Manager, Regulatory Affairs - CNS (EGC) Regulatory Affairs Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Develop, implement and execute regulatory strategic plans and best practice departmental procedures for the therapeutic area group * Provide regulatory guidance for top-level project development/core teams * Actively liaise with FDA and r