- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Assurance. Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, ... functional units and corporate functions.Lead Training function team and Document and record management function team to enhance training and document and record… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …use of standards. Works closely with site stakeholders on training and document needs. Relationships Reports to: according to the organizational chart. Essential ... for sharing of best practices to/from other M2-US or NN teams Lead document control process across site Design & own process for implementation of new/revised… more
- Aequor (Thousand Oaks, CA)
- Fully remote MCS Supply Chain Sr Associate Ideal candidate: Experience is document management. Very document orientation and detail oriented Description: Reports ... - Support inventory reconciliation for inspection readiness - Support document upload in eTMF and ensure document ...Support document upload in eTMF and ensure document readiness for inspection Qualifications: Master's Degree & no… more
- Repligen (Waltham, MA)
- …tracker information, cross-functional daily communication, batch record reviews, document revisions, IOPQ qualification documentation and executionThis role will ... also provide extensive support with document writing, document revisions, and handling investigations. Must have thorough understanding of Good Documentation… more
- Merck & Co. (Rahway, NJ)
- …collaboratively with cross-functional teams.Ability to review own work to ensure document quality (eg, accuracy, completeness, reading level, grammar, and alignment ... with document requirements).Technical expertise in office applications (eg, Microsoft Office Suite, Adobe Acrobat) and shared document systems (eg,… more
- Merck & Co. (Rahway, NJ)
- …problem-solving capabilities.Ability to meticulously review own work to ensure document quality (eg, accuracy, completeness, reading level, grammar, and alignment ... with document requirements)Technical expertise in office applications (eg, Microsoft Office...applications (eg, Microsoft Office Suite, Adobe Acrobat) and shared document systems (eg, SharePoint); familiarity with medical writing-specific tools… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifications for Veeva CRM. Collaborate with business stakeholders to gather and document business needs, objectives, and processes related to Veeva CRM as it ... experience required) in and out of Veeva CRM system.- Documentation: Document various system related documentations such as system configurations, data flow… more
- Formation Bio (New York, NY)
- …documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing oversight to the assigned author. Partners with ... risk assessments. Develops and implements continuous improvement processes for document writing processes. Accomplishes department objectives by managing and leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the TMF document trackers generated by the CRO with the document ... information on required public forums (eg.clinicaltrials.gov).Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and… more
- Aequor (Thousand Oaks, CA)
- …risk identification, tracking and planning for mitigation of risks. Develop and document business processes in the form of process flows, SOPs/business practice ... business continuity plans for approval. Administration (if necessary) of 's document repository software. Support the development of and approve risk assessment… more
- Eisai, Inc (NJ)
- …for internal/ external audits and inspections, which may include supporting document retrieval during audit/inspection and speak to eTMF current state, history ... CDISC TMF Reference Model GroupKnowledge/understanding of technologies to support document collection and archiving.Administrative experience with management of SharePoint… more
- Eisai, Inc (Nutley, NJ)
- …clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and maintaining ... project trackers in EPICProvides support for document preparation and follow-up (eg Informed Consent Form, eTMF fling plan, Co-Monitoring Plan)Creates Clinical Trial… more
- Novo Nordisk Inc. (Durham, NC)
- …Troubleshoot and resolve issues related to XR application development and deployment Document and test XR solutions to ensure the performance and functionality are ... conduct performance and usability tests with industry standard tools, and document gained data appropriately required Good understanding in transforming business… more
- Aequor (Seattle, WA)
- …proactive and independent thinker.Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), ... Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.Exceptional interpersonal… more
- Merck & Co. (Rahway, NJ)
- …technology solutions to improve efficiency and reduce legal costs. Help document legal processes/procedures to keep our internal knowledge management portal updated. ... Keep abreast of market trends, alternative fee arrangements, and best practices. Legal Services Spend Reporting and Analytics: Manage legal spend reporting and analysis, including maintaining and enhancing PowerBI dashboards. Analyze spending patterns to… more
- Aequor (Thousand Oaks, CA)
- …GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no ... foundation. Must be able to methodically and meticulously inspect printed materials for print quality defects, clinical product components (eg syringes and vials) for physical defects, and batch record documentation for accuracy and completeness. Must be able… more
- Merck & Co. (Rahway, NJ)
- …within electronic computer systems, eg, Material Management Systems (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems, etc.Support MDCP ... sites with new/revised QMS Quality Standards and/or Global Procedures.Perform related duties, as assigned. Skills Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management… more
- Repligen (Clifton Park, NY)
- …abilities. Experience working in a classified cleanroom, and knowledge of GMP/ISO/ document -controlled processes would be beneficial. Attention to detail, and the ... ability to work in a team environment are essential. ResponsibilitiesLead and supervise all site personnel involved, collaborating with headquarters functions for harmonization for matrixed roles.Lead all operations at the site, including Planning,… more
- Merck & Co. (Rahway, NJ)
- …best practices, processes, and procedures.Use our DCIM tool Sunbird to document , design, and plan IT equipment installations for our Technology Spaces.Qualifications ... Required 5+ years operating and supporting enterprise DC environments with 24x7x365 uptime requirements.5+ years' experience designing and deploying Technology Spaces supporting servers, storage, and virtualization technologies across multiple vendors in a… more
- Aequor (Aliquippa, PA)
- …Distribution Practices (GDP) and other applicable regulations Perform cGMP process, procedure, document and record review, and approval, including but not limited to ... deviations, CAPAs, change controls, risk assessment, and validation records Perform incoming raw material inspection, environmental monitoring, and documentation review Provide leadership updates regarding the health and initiatives relating to the QMS at site… more
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