- Merck & Co. (Rahway, NJ)
- …regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product ... and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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).ResponsibilitiesReconcile the TMF document trackers generated by the CRO with the document … more
- Insmed Incorporated (Bridgewater, NJ)
- …such that all components are provided and presented in the correct format.Manage document review and approval as needed.Assists with other projects to support ... submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission… more
- Merck & Co. (North Wales, PA)
- …regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... business processes and systems.Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(LIMS). Prepare documents and coordinate Sample shipment (internal and external shipments). Review logbooks and/ or LIMs to align physical quantities of samples in ... freezers/refrigerators. Periodic inspection and consolidation of retains. Document and perform sample management related non-conformance investigations. Document … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed.Responsibilities- Contract Coordination: Collate exhibits to create contract draft, Review contract documents for completeness and accuracy; Ensure compliant ... Update CLM system/trackers throughout the process.- Conduct simple negotiations review contractual amendments details against original contract. Ensure internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational input into study protocol profiles, final protocols and amendments.Lead document review & coordination for the protocol and amendments. ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategic and planning alignment across regions and functions, and supports review of local country/regional Medical Affairs activities when applicable. Provides ... evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Merck & Co. (Boston, MA)
- …include the clinical pharmacology support of the Common Technical Document (CTD) and label, including relevant compound/program life-cycle management.The successful ... TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based… more
- Merck & Co. (Rahway, NJ)
- …include the clinical pharmacology support of the Common Technical Document (CTD) and label, including relevant compound/program life-cycle management.The successful ... governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of… more
- AAOS (Rosemont, IL)
- …the General Counsel, the Associate General Counsel provides corporate legal advice and review , research, and analysis on a wide variety of topics. Administers the ... Center Property Owners Association (affiliated entities). Conducts the primary, initial review of department contracts, creates initial drafts when there are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current training modules ... its annual and periodic Compliance policy and procedure plan, including the review and renewal of existing policies and procedures.Maintain current and accurate… more
- Merck & Co. (Rahway, NJ)
- …problem solve/troubleshoot, with knowledge of root cause analysis.Ability to prepare/ review Standard Operating Procedures (SOP) and cGMP documents.Experience with ... thinking and technical writing skillsProficient in MS Office Platform and document storage systemsAn ability to foster innovation, creativity, and self-initiative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …property colleagues (in particular in Japan)- Supports invention disclosure tracking, review , and evaluation- Drafts and/or assists in the drafting of IP-related ... BD contracts and related documents are properly stored in legal document repository- Other department-specific or cross-functional projects or tasks as assigned… more
- Merck & Co. (Rahway, NJ)
- …it relates to the calculation and reconciliation of Intercompany Profit.Gather and document business process and business / user needs to support the implementation ... facility or meet with stakeholders). -Please understand that, as permitted by applicable law , if you have not been vaccinated against COVID-19 and an essential… more
- BioAgilytix (Durham, NC)
- …maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networksAssist in document ... and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any...results of genetic testing, service in the military, or any other group protected by federal, state, or local law… more
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