- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and biostats to ensure availability of necessary data- Coordinate author review /approval internal review approval- Abstract/manuscript submission with vendor ... in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author… more
- Eisai, Inc (Nutley, NJ)
- …and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but is not limited to: Program design ... areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical...Assoc. Director of Clinical Programming will oversee the Data Review programming and JReview within IODS. Reporting to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... Operations and other cross-functional and regional stakeholders.- Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound… more
- Genmab (NJ)
- …learningsRepresents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results ... deviations classifications, DSUR, IB updates, tables, figures, and listings etc. Review assay validation reports, as applicable Perform exploratory analysis, ad hoc… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI contracts under negotiation (eg development,… more
- Eisai, Inc (Nutley, NJ)
- …strategic plan for assigned therapeutic area(s). These deliverables include development and review of compliant scientific exchange materials to be used in external ... and other senior-level medical communication initiatives as needed.Manage and support the review of SEM and internal medical documents through Medical Review … 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 ... completing requests/initiatives from the GSOP Committee)Proactively manage required periodic review for controlled proceduresEnsure global and cross-functional consistency of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewUnder specific direction, the Payroll Specialist will review and process bi-weekly payroll for approximately 400 employees.Will transmit direct deposit files ... to financial institutions and prepare manual checks as needed, maintain and review timesheets submitted through the electronic time collection system, compile and… more
- Genmab (NJ)
- …learningsRepresents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results ... deviations classifications, DSUR, IB updates, tables, figures, and listings etc. Review assay validation reports, as applicablePerform exploratory analysis, ad hoc… more
- Repligen (Waltham, MA)
- …Compile Quality metrics as inputs for monthly KPI's and management review meetings with the Senior Management team.Facilitate operational excellence initiatives in ... compliance across the organization and in support of the ISO 9001 standard. Review and approval of validation plans, deviations, failure investigations and corrective… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for ... within the siteReview and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for… more
- Eisai, Inc (Nutley, NJ)
- …IV clinical development programs for assigned products. Create IIS strategies and review proposals in conjunction with company policies. Participate in review ... key internal business processes including active participation in relevant medical review committees.Work with key internal stakeholders to support development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with ... and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document verification and targeted source… more
- Merck & Co. (North Wales, PA)
- …scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... Rheumatology, or ophthalmology, especially autoimmune or immune-mediated disorders.Experience with review of participant eligibility for trials (eg, inclusion and… more
- Aequor (Houston, TX)
- …and performance of associate interviews. Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to ... Attendance and occasional leadership of the daily management system and participating/leading the deviation review board. Perform other duties as assigned. more
- Merck & Co. (Durham, NC)
- …GMP, and calibration/maintenance procedures.Uses the SAP work order system to review work requests, identify required stock and non-stock materials, ensure ... to be in compliance and up to date with calibration orders. Review 's vendor calibration certificates.Maintain secondary and or working calibration standardsEducation… more
- Merck & Co. (Rahway, NJ)
- …tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to recruit, select, ... and other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure to project /… more
- Eisai, Inc (Raleigh, NC)
- …collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness, accuracy, and compliance ... quality assurance functions in a GMP setting (eg, batch record review , SOP writing, auditing, batch release functions, deviation investigation and resolution,… more
- Merck & Co. (Durham, NC)
- …to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality ... Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved… more
- Merck & Co. (Durham, NC)
- …to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality ... Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved… more
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