- Daiichi Sankyo, Inc. (New Orleans, LA)
- …informationIdentifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) ... for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boardsGathering customer insights regarding DSI and competitor… more
- BioAgilytix (Durham, NC)
- …chromatographic and mass spectrometric (LC/MS) techniques in support of preclinical, clinical , and product release studies .Design, plan, and execute experiments ... Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies -including project scope definition, proposal preparation, timelines, scheduling, budget,… more
- Genmab (NJ)
- …and editing of critical documents such as protocols, investigator's brochures, and clinical study reports.Contribute to Health Authority briefing documents and ... immunology experience preferredDemonstrated experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should… more
- Merck & Co. (Rahway, NJ)
- …for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards ... and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.The incumbent will be… more
- Merck & Co. (North Wales, PA)
- …final regulatory review and approval of:Worldwide marketing applicationsClinical study protocols and reportsInvestigator brochuresLocal registration study ... initial content review and approval for IND/CSA submissions to enable clinical trial initiation.Participate in regulatory due diligence activities for in-licensing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects.At the time of implementation of a CDx study /IVDR performance evaluation study integration of an assay into clinical testing (before testing) and ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Merck & Co. (North Wales, PA)
- …PK, PD and covariate dataProduce tables and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to ... or related field plus 5-9 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences,… more
- Eisai, Inc (Nutley, NJ)
- …regional medical directors and MSL leadership, Publications, Medical Communications, Clinical Development, Biostatistics, Field HEOR, Patient Advocacy, and other ... prepare medical affairs personnel to enter strategic and compliant discussions regarding medical/ clinical data on Eisai products. The AD assumes a leadership role by… more
- Genmab (NJ)
- …through scientific exchange in a fair and balanced manner and provide clinical /scientific support for Genmab's pipeline.Domestic travel of approximately 50% will be ... regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical data that enhance the value and appropriate use of… more
- Eisai, Inc (Exton, PA)
- …supply of DS/ADI for pre- clinical and phase I to phase III clinical studies , including the development of long-range planning and weekly production ... in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well...produce material for toxicology and phase I to III studies ), and in the late-stage processes at CMOs that… more
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