- Vitalief (New Brunswick, NJ)
- …as needed. + Facilitates clinical trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with ... is complete and accurate and to ensure that the research project , database or protocol is carried... of financial data and transactions. + Experience in clinical research administration; knowledge of regulatory… more
- J&J Family of Companies (Titusville, NJ)
- …Disease is required + Requires at least 10 years of experience in clinical research and development (including Phase 2-3b studies). + Experience interacting ... Pre- Clinical / Clinical Development **Job Sub** **Function:** Clinical Development & Research - MD **Job...to a matrixed cross-functional Compound Development Team and the Clinical Team. Team matrix interactions may include project… more
- System One (Florham Park, NJ)
- …reports, and strategic documents for leadership discussions. + Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure ... regulatory documents related to antiviral programs to regulatory authorities. + Conducting research on ...+ Preparation of Type C/B/D Meetings for antivirals in clinical development (as needed) + Contributions to and finalization… more
- Bristol Myers Squibb (Princeton, NJ)
- …to regulatory submissions. This individual will work on cross-functional project teams to drive execution of translational/biomarker plans working with disease ... and lab scientists, as well as BMS members from clinical , medical, commercial, regulatory , and diagnostics. Individual will also engage with external academic… more
- Bristol Myers Squibb (Princeton, NJ)
- …the Global Research organization in BMS and leads late stage clinical , pharmacological and translational research and development activities for the pipeline ... and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives strategy across core… more
- Parexel (Trenton, NJ)
- …business management is desirable. + Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with ... Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), project management ... 1 to 2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external (contract research organization [CRO], bioanalytical… more
- Sanofi Group (Morristown, NJ)
- …Matrix leadership and dotted-line management toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational ... GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with...health care solutions along the whole value chain from research up to market access. Skilled in project… more
- J&J Family of Companies (Titusville, NJ)
- …Represent Clinical Development at Regulatory Authority Meetings. + Present the clinical development aspects of a project and clinical trial results ... Pre- Clinical / Clinical Development **Job Sub** **Function:** Clinical Development & Research - MD **Job...interpret clinical trial data, provide input into clinical study and regulatory communications and reports,… more
- J&J Family of Companies (Titusville, NJ)
- … project management, finance, legal, quality assurance & compliance, clinical supplies, regulatory affairs, data management, medical writing, biostatistics, ... in preparation for health authority submissions + Close interactions with Project Clinical Scientists and Physicians across programs **QUALIFICATIONS:** +… more
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