- Merck & Co. (Rahway, NJ)
- …process selection. In summary, our team enables the translation of preclinical candidates into non -oral drug products. Our team is looking for a strong candidate ... Sterile and Specialty Products (SSP) group is responsible for developing non -oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and… more
- Merck & Co. (Rahway, NJ)
- …summary, our team enables the translation of preclinical candidates into non -oral drug products.Primary ResponsibilitiesDesigning and developing sterile products ... sterile dosage forms including ocular dosage forms, peptide therapeutics, and non -conventional drug delivery technologies (eg emulsions, suspensions, injectable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management processes and systems as appropriate.Strategic Planning: Contribute to or lead non - drug projects related to RD strategy. Represent Daiichi Sankyo at ... skills to clearly present options and solutions to optimize the drug development portfolio across both Oncology and Specialty Medicine.Portfolio Reporting and… more
- Insmed Incorporated (Bridgewater, NJ)
- …and/or oversee PK, PK/PD and pharmacometric analyses for clinical and non -clinical studiesApply model-based drug development strategy to support clinical ... principles, ADME concepts, and clinical pharmacologyThorough understanding of overall drug development programs and familiar with clinical pharmacology related… more
- Catalent (St. Petersburg, FL)
- …analytical scientists to complete milestones for development programs.Perform compendial and non -compendial testing on raw materials, drug substances, in-process ... will independently test raw materials to both compendial and non -compendial methods. Catalent is committed to a Patient First...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non -significant/significant risk determinations (both submission to CDRH in a Q-sub ... (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into...robust development of assay, participate in HA interaction for drug -related CDx topics/questions, and attend device company HA meetings… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker ... and apply Quantitative Systems Pharmacology (QSP) models to address drug -discovery and development questionsDevelop a QSP strategy to address prioritization… more
- Merck & Co. (Rahway, NJ)
- …for development of new technologies/capabilities, execution of capital and non -capital improvement projects, and interfacing with the automation system assets ... a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned… more
- Merck & Co. (Rahway, NJ)
- …Expertise in testing, characterization, and troubleshooting of: Combination product drug delivery device components - plastic, metal, glass, elastomeric materials, ... (eg, accelerated and real time) and root cause investigations of drug delivery systems, eg, inhalers, auto injectors, pen injectors, on-body infusers/injectors,… more
- Merck & Co. (Rahway, NJ)
- …the-development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, ... chemical and biochemical processes, market formulations, and their processes for non -sterile and sterile products.- It also includes strategic partnering with CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... project manager in support of a larger, more complex drug development project. As a project manager this position...departmental level objectives and may also participate on a non -project initiative in support of these objectives. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …goals, including change management and implementation planning, for GOCD non -project related initiatives. The Associate Director, GOCD Functional Excellence must ... Collaborates with key stakeholders to ensure appropriate buy-in and ownership of non -project deliverables. Acts as a change agent in support of process improvement… more
- Merck & Co. (North Wales, PA)
- …in an environment where they are interacting with multiple channels to access drug , medical and practice management information as needed, real-time. To enhance our ... promotional mix. In this role, the Customer Engagement Manager will define non -personal promotion HCP customer channel and engagement strategies for our Company's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation in support of Final Product Shipments. Generates inspection reports and non -conformances for failures as required. Scanning, filing and archival of QA ... skills in relation to procedures, regulatory standards, and company policies. Ensure non -conformances are investigated thoroughly and approved in a timely manner and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non -clinical Development. Essential Functions Authors, edits, and provides QC review ... clinical evaluation reports (CER) Pediatric investigational plans (PIP) Orphan Drug applications Breakthrough Therapy Designation requests Clinical summary and… more
- Aequor (Seattle, WA)
- …Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development. Cross-functional Project Management to ... Coordinate and ensure appropriate allocation of DS and API materials for non -clinical use Experience / Qualifications: Bachelor's degree in engineering or relevant… more
- Catalent (St. Petersburg, FL)
- …includes rating, investigating and following up with operators for non -conformance issues and working jointly towards resolution.Provide guidance and plan ... and lead cross functional team to classify events and deviations of non -compliant issues according to procedures as defined by SOPs.Prepare complaint investigation… more
- Marion County (Salem, OR)
- …illness and symptomatology; psychotropic medications, medication management, dispensing, drug interactions, and side effects; medication documentation (including MAR ... incident reporting, etc. Provides in-person and technology-based training to nursing, non -nursing, persons served, guardians, and staff in the following settings:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non -Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs ... requirements Work with the VP Medical/Scientific Development, Clinical Operations, Non -Clinical Research, Medical Writing, Program Management, CMC and Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the designated programs.Ensure proactive representation of Quality professionals at strategic non -project team and at CSPV strategic discussions.Take the lead as the ... of integrity, respect, and culture of speak up with non complianceLead and hold others accountable to performance, talent,...agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+… more
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