- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. ... portfolio. This role as CSO (Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study Supply Plans, managing… more
- Merck & Co. (Rahway, NJ)
- …support to the organization to facilitate and implement new quality systems introductions and/or improvements. Assists with and/or lead the development, and ... participate in cross functional initiatives to develop and optimize Quality systems and business processes. - The... (QRM) Facilitator Experience with Quality Risk Management , External Entity Oversight, Quality Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Merck & Co. (Rahway, NJ)
- …knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management systems and quality control tools is ... & Enterprise Management , related to regulatory agency inspections.Act as the Quality Management subject matter expert and primary point of contact for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems .Company Sponsored Studies (CSS) ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review and approvals… more
- Merck & Co. (Rahway, NJ)
- …with the overall business goals.Drive innovation and continuous improvement in SAP systems and processes.Team ManagementBuild and lead a high-performing team of ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...They will ensure the smooth operation of our SAP systems with a mindset towards continuous improvement.- Their expertise… more
- Merck & Co. (Rahway, NJ)
- …affairs.Three (3) years of experience in managing regulatory submissions and document management systems such as Veeva Vault and RIMSStrong knowledge of ... individual with a strong background in regulatory affairs and project management to support our cross-functional projects and streamline our regulatory operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Good Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality systems , cGMP, and Learning Management System (LMS) ... experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …many stakeholders.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to complete ... multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of...in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all ... and industry best practices.Ensure /support the development of GLP/GCLP systems , risk management processes such as SOPs... Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational ... and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions of Daiichi Sankyo… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Essential Functions Revenue Management Systems (Contracting, Medicaid, Govt. Pricing, Chargebacks) Technologies Leadership ... support and rollout of relevant technologies and platforms. Accountable for overall quality and delivery of Revenue Management (Contracting, Medicaid, Govt.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive continuous improvement.Have advanced computer ... is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA...based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliant execution of all congresses.Responsibilities- Congress Planning and Execution Management - Manage the planning and onsite execution for the global and ... list of congresses that would best support the company and brand objectives.- Lead planning and execution weekly meetings with Global and/or National Congresses key… more
- Merck & Co. (Rahway, NJ)
- …and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, ... focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team...testing, and process validation, with a strong understanding of quality management systems and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …administration of validated electronic systems such as LMS or other quality management systems .- Strong interpersonal, communication, negotiation and ... project teams. This position has advanced skills in technology systems , including word processing software and data management...data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate… more
- Merck & Co. (Rahway, NJ)
- …Environmental Policies and Procedures. Familiarity with Computerized Maintenance and Management Systems (CMMS). Reliability-based engineering experience and ... Primary responsibility will be to maintain the Rahway based clinical equipment, systems and facilities in accordance with GMP and Safety requirements, as well… more
- Eisai, Inc (Nutley, NJ)
- …strategy.Provide business consulting services to key business stakeholders including systems integration best practice and process excellence principles. Lead ... university degree in the field of computer science, information science, management information systems , or business administration preferredExperience leading… more
- Eisai, Inc (Nutley, NJ)
- …College diploma or university degree in computer science, information science, management information systems , or business administration. 3-5 years related ... allowing us to meet Eisai business needs. Strong understanding of project management principles and Systems Development Life Cycle standards and familiarity… more
- Merck & Co. (Rahway, NJ)
- …pipeline. This role may support facility operations, support compliance investigations/change management , author GMP documentation and manage/ lead engineers in ... providing technical mentorship.Experience with Potent Compound processing and containment systems (eg, isolators).Experience with Quality systemsNOTICE FOR… more
