- Aequor (Thousand Oaks, CA)
- …with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have ... sampling for Biotech/pharma Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to detail and excellent communication… more
- Eisai, Inc (Exton, PA)
- …processes and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company's ... discretion.5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the organization follow the hierarchyLead establishment of principles for document and record management processes including authoring, review , approval, ... Quality Assurance. Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units,… more
- Aequor (Aliquippa, PA)
- …Distribution Practices (GDP) and other applicable regulations Perform cGMP process, procedure, document and record review , and approval, including but not ... staff and partner groups Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to post trial information on required public forums (eg.clinicaltrials.gov).Under supervision, review and document CRO-generated reports, such as site monitoring ... compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the TMF document trackers generated by the CRO with the document … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes, and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document verification and targeted ... disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with… 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)
- …environment, working both independently and collaboratively with cross-functional teams.Ability to review own work to ensure document quality (eg, accuracy, ... medical writing responsibilities, including design, planning, writing, editing, and review of accurate, clear, high-quality documents that reflect the principles… more
- Merck & Co. (Rahway, NJ)
- …cross-functional teams.Demonstrated critical thinking and problem-solving capabilities.Ability to meticulously review own work to ensure document quality (eg, ... medical writing responsibilities, including design, planning, writing, editing, and review of accurate, clear, high-quality documents that reflect the principles… more
- Formation Bio (New York, NY)
- …writing strategies and operational plans.Responsibilities Leads and manages the writing, review , and finalization of clinical development documents such as protocol ... documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing oversight to the assigned author. Partners with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this ... as a key regional point of contact for cross-functional process and procedural document related questions. The individual in this role will also be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as needed.ResponsibilitiesContract Coordination: Collate exhibits to create contract draft, review contract documents for completeness and accuracy; ensure compliant ... and update CLM system/trackers throughout the process.Conduct Simple Negotiations: Review contractual amendment details against original contract. Ensure internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complex study problems.Responsibilities:Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Genmab (NJ)
- …with cross-functional trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing support to elevate ... and ICH guidelines.Proficiency with writing tools such as MS Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical data… more
- AUROBINDO (Durham, NC)
- … Document work clearly and perform tests accurately.Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.Perform maintenance and calibrations ... chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of Analytical documents as requiredQualifications - Skills & RequirementsBS… more
- AUROBINDO (Durham, NC)
- …as LIMS, Quality Assurance Management System (QAMS),Waters Empower, Document Management System, Training ManagementSystem etc.ResponsibilitiesEnsure key software ... development lifecycle (SDLC) processes, such as ChangeControl, Release, Deviations, etc. Review and approval of test scripts and defects associated with… 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 ... CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the Quality Manual.Previous experience in Medical… more
- Merck & Co. (Rahway, NJ)
- …vials, medical device release testing in a timely manner following GMP procedures. Document the execution, procedure, results, and conclusions of experiments in a ... certificates, investigations/deviation records, and SOPs. Perform data entry, data review /approval, and author analytical reports or data summaries.Troubleshoot and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in design and geographic scope). Prepares clinical section of regulatory document . Collaborates as team member with AROs/CROs. Drafts development plans, protocol ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Regions Bank (Hoover, AL)
- …section of the system. **Job Description:** At Regions, the Enterprise Operations Document Review Specialist ensures loan documentation is complete and accurate ... Schedule for a minimum of three years. You may review , modify, or update your information by visiting and...clear and concise written communication on missing or incorrect document exceptions This position requires the tracking of time… more
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