- 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)
- …the DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various ... and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes… 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)
- …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)
- …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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and ... documentation of testing.Create, review and approve relevant QC documents, SOP's and WI's.Perform...constraints and desired outcomes to make effective decisions.Employs good project management principles to appropriately align time, resources, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to the policy ... Head a monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the appropriate section of… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality.Work closely with Sr. Manager, Strategic Initiatives to ... design of facility upgrades to support integration of new technology.Ensure project deliverables are executed in an effective, efficient, and compliant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various department projects to drive continuous ... lead as a change agent to promote flexibility, creativity, and accountability. Project management skills, responsiveness to issues, and demonstrated passion for… 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)
- …issue resolution Queue Management : Monitor and manage procurement queues, review purchase orders, change orders and marketplace purchases, assist suppliers with ... needed Tools and Systems : Provide support for emerging tools including project databases, Power BI dashboards, and digitized procurement processes; Represent the… 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)
- …laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures.This position is based at the Rahway, New Jersey ... associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and… more
- Merck & Co. (Rahway, NJ)
- …data review , and author analytical reports and data summaries.Conduct project management and/or scientific oversight of studies and samples performed at Contract ... laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the Rahway, New… 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)
- … review technical documents. Complete assigned work within established project timelines. Support GMP compliance and continuous improvement of laboratory ... ALCOA principals and SOPs. - Ability to manage work to meet project timelines. Capability to work independently with minimal supervision. Ability to identify… more
- Merck & Co. (Rahway, NJ)
- …to headquarters submission (ex-USA) and in collaboration with RDMAs, while also serving as a review panel member on TA specific MISP's to support the EDSA review ... analytical, communication skills (written and oral) in addition to results-oriented project management skillsPreferred: At least 3 years regional medical affairs… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical, project , and people management responsibility. - This SSO Facility Lead role within the SSO ... and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard… more
