- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Daiichi Sankyo's mission by leading conversations across functional teams (ie Grant Review Committees) around the grant and/or project decisions that meet the ... Internal Strategy and Operations- In alignment with senior colleagues, collect, review , and make decisions in collaboration with relevant Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the ... quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, ... level.- Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership teams). Functional Expertise:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Process for the respective business areas.Responsibilities:Leadership and Project Management:Lead the end-to-end quality execution across Medical Affairs ... QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs).… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and gene therapy components and associated manufacturing processes.Provide support in project management, purchasing, shipping, and invoice review for technical ... decisions that drive both supply assurance, cost savings as well as project executions.The individual manages suppliers from contact to contract within a category,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including project -specific training and coaching of team members and review of team output cross-functionally.Effectively represent the CSPV on the Global ... Safety MD, will lead the development and implementation of integrated project /product risk management strategies aimed at achieving the optimum benefit-risk for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in setting strategies and plans for their teams with the CROs. Responsible to review metrics and issues for their studies and ensure proper attention and mitigations ... the needs of the overall development plan agreed to by the Global Project Team (GPT). People and Resource Management:Develops talent through providing focused career… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to optimize and enhance efficiencies and ways of working. Takes ownership and project manages a high volume of high level projects which involves working with ... suppliers and internal stakeholders to define scope and review of work orders and agreements, Mitigates supplier issues, develops action plans to resolution. Leads… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance with written ... Policies and procedures as required for batch releasePerform First Quality review for executed batch records dailyPerform other assigned duties as may be required in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo ... post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review and document CRO-generated reports, such as site monitoring trip… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring ... Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product ReviewsWorks in a collaborative team setting with Quality,… more
- Genscript USA Inc. (Piscataway, NJ)
- …performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility Engineer will provide high-level technical oversight ... lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.- - Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all ... the Company development products and non-Company marketed products. Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and… more
- Merck & Co. (Rahway, NJ)
- …Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic and operational plans associated ... and distribution for Clinical Finished Goods (CFGs) - Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendor related activities in Patient Safety including, but not limited to contract review and vendor management support in regard to safety reporting. To serves as ... initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, management of SDEA requirements, and supplier… more
- Merck & Co. (Rahway, NJ)
- …with applicable USDA regulations/ guidelines, customer requirements, SOPs and project specific guidelines/ instructions.Evaluate audit findings and ensure timely ... health authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer , compliance officer, other GMP/regulatory role or Site Quality Head… more
- ValSource, Inc. (Rahway, NJ)
- …equipment, etc. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required ... conduct Risk Assessments and Impact assessments, and establish system boundaries Generation, Review , and editing of Standard Operating Procedures. Review and… more
- Merck & Co. (Rahway, NJ)
- …main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… more
- Merck & Co. (Rahway, NJ)
- …activities performed by external partners.Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, ... milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.)… more
- Merck & Co. (Rahway, NJ)
- …updates to templates. The successful candidate will be expected to: Review , draft and/or develop legal documents and communications independently. Independently ... wide array of legal documents. Screen requests for legal advice/support, and review information provided from client for completeness, as needed. Respond to… more
