- Eisai, Inc (Nutley, NJ)
- …Continuously update plans and inform stakeholders of progress. 30%Phase IV clinical studies : Direct and design strategies, planning and implementation of Phase IV ... the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory guidance regarding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document development ... other cross-functional and regional stakeholders.Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global… more
- Novo Nordisk Inc. (Boulder, CO)
- …of oligonucleotides Provide analytical support for drug product formulation studies , including osmolality, viscosity, HPLC, UV Conduct stability studies ... for drug substance and drug product Ability to run a multitude of analytical instrumentation to support manufacturing; UV-vis, KF, HPLC, GC, LC-MS, Endotoxin, etc. Knowledge of calibration and routine maintenance of instrumentation used in the analytical lab… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior ... relating to the execution of the Audit Management Plan for assigned studies Responsible for health authority (eg, FDA) inspection preparedness and execution Physical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of efficacy (ISE)- Direct Project Support: Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors ... of analysis data standards for AML as well as solid tumor studies - Leadership of Strategic Initiative and Cross-Functional Collaboration: Provide leadership for… more
- Aequor (Willow Island, WV)
- …Receives and prepares samples for analytical testing and initiation of stability studies . Performs physical testing of routine and non-routine samples with little ... Safety requirements and Standards. Conducts laboratory activities related to experiments, studies , and projects in support of production, laboratory, or other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will act as main statistical contact for the assigned studies , in particular in cross-functional Study team(s).Responsibilities- Study Responsibility - ... readiness as well as prepare potential audits linked to assigned studies .- Vendor Oversight Under limited supervision, responsible for providing direction and… more
- Aequor (New Brunswick, NJ)
- …Description: 100% onsite The Assistant Scientist is responsible for supporting studies to establish oral solid formulations. This includes execution of laboratory ... and pilot plant work, design experimental formulation studies , and conduct material characterization and formulation testing. REQUIRED COMPETENCIES: Knowledge,… more
- Aequor (South San Francisco, CA)
- …scaled-up synthesis of lead molecules and coordinate material delivery for preclinical studies . Maintaining a high level of productivity in the laboratory setting to ... meet the timelines for in vitro and in vivo studies . Requirements: The candidate must have hands-on experience in oligonucleotide synthesis using automated oligo… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and/or review manufacturing process transfer plans, protocols, and reports. Design studies , draft protocol, oversee execution and draft reports necessary to support ... for cell therapy development and manufacturing. Perform technical feasibility studies related to process improvement and implementation of new manufacturing… more
