- Merck & Co. (Durham, NC)
- …including periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including ... VMF's to include the following:Direct in-line Quality support for all cGMP compliance , batch review , and environmental monitoring matters. Review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Global QA mission across boundaries and with different stakeholders. Continuously review compliance metrics trends from regulators/ industry experts and ... role that is responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of… more
- BioAgilytix (Boston, MA)
- …here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by ... OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work closely with the scientific staff to ensure data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing materials and promotional activities. Work closely with legal, regulatory, and compliance teams to review and approve promotional materials, ensuring ... resources to ensure attainment of unit, department and Company profitability goals Compliance and Regulatory: Ensure compliance with regulatory requirements and… more
- Marion County (Salem, OR)
- …to apply tracking systems; develop contract timelines, monitor timeline to ensure compliance by all parties; review required paperwork to ensure inclusion ... procedures; and work with appropriate internal and external parties to ensure financial compliance procedures are in place, compliance with grant performance is… more
- Eisai, Inc (Nutley, NJ)
- …want to hear from you. Job Summary: As the Americas IT Security and Compliance Director, you play a pivotal role in ensuring the organization's adherence to ... security, regulatory, and compliance standards. Collaborating with business and EIT stakeholders, you promote awareness of best practices and strengthen … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and ... laws, guidelines, and regulations. This individual will partner with members of the Compliance team on critical projects and provide support; will be responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and appropriate.Support the team in developing and tracking its annual and periodic Compliance policy and procedure plan, including the review and renewal of ... rare diseases and immune disorders. SummaryThis position will be part of the Compliance organization and will report directly to the Director, Compliance … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role ... Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory ...team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements. Develops… more
- Medina Center for Rehabilitation (Valley City, OH)
- …changes. - Coordination - Interacts with Medicare, Managed Care and Medicaid claims review unit and compliance unit to assist facilities in complying with ... intermediary in professional areas of coverage and documentation. - Assists in review and preparation of denied claims or administrative record reviews by outside… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document and manage records for corrective and preventative actions, ensuring compliance with regulatory standards. Draft, review , and approve Standard ... Conduct regular reviews of system audit trails / periodic review to ensure data integrity and compliance ....periodic review to ensure data integrity and compliance . Manage equipment access rights and perform periodic reviews… more
- Merck & Co. (Durham, NC)
- …Right First-Time culture by reducing waste and constantly driving continuous improvement-- Review and approve compliance documents, as per procedures or ... standard operating procedures that impact the efficiency and effectiveness of own unit. Compliance - Creating and sustaining a culture that ensures that compliance… more
- Merck & Co. (Durham, NC)
- …culture by reducing waste and constantly driving continuous improvement. -Responsible to review and approve compliance documents, as per procedures or ... operating procedures - that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture that ensures that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for the creation, management, and documentation of GCO's CRO SOP review and maintaining the master Daiichi Sankyo (DS) SOP list for ... the ownership and maintenance of GCO-owned procedural document packages.Lead authoring, review , and periodic reviews/updates for all GCO procedural packages and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Standards and Procedures (SOPs) and Training Activities: Responsible for development and review of procedural documents that set compliance in QA GMP ... to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and ...for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Merck & Co. (Rahway, NJ)
- …through participation in equipment design and testing as well as preparation, review , and completion of GMP documentation. Support compliance with Industrial ... to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lead and biostat to ensure availability of necessary dataCoordinate author review /approval & internal review approvalSubmit abstract/manuscripts with vendor ... in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author… more
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