- Merck & Co. (Rahway, NJ)
- …etc.) and keeps them informed of the study progress.May be the Global Clinical Research (GCR) representative in the project team. Assume responsibility for ... and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and… more
- Merck & Co. (Rahway, NJ)
- …quality assurance, and analytical teams involved in GMP activities, validation and Quality Control testing. This role will be instrumental in establishing ... Job DescriptionAn excellent opportunity is available for an Analytical Research and Development (AR&D) Associate Principal Scientist to serve...timelines for clinical deliverables and ensuring commercial laboratory readiness for product… more
- Merck & Co. (Rahway, NJ)
- …Material(s):Required Skills:Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research , ... Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories portfolio… more
- Merck & Co. (Rahway, NJ)
- … Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories portfolio ... strategy for clinical supplies.-Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to… more
- Merck & Co. (Rahway, NJ)
- … Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories portfolio ... Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with ... acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements… more
- Formation Bio (New York, NY)
- …the PositionWe are seeking a highly motivated and detail-oriented Analytical Development and Quality Control biologics expert to join our CMC team. The ideal ... pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines… more
- Formation Bio (New York, NY)
- …to ingest and transform unstructured and structured research , biomedical and clinical data into high- quality , actionable assets that power discovery and ... pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and… more
- Eisai, Inc (Raleigh, NC)
- …the Director will oversee Global Logistics and Import/Export compliance for commercial, clinical , and research materials. This includes the Eisai Customs and ... the Director will oversee Global Logistics and Import/Export compliance for commercial, clinical , and research materials. This includes the Eisai Customs and… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing ... team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1… more
- Merck & Co. (Durham, NC)
- …As a result, VCM Product Managers have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity of supply, ... post-approval physical product enhancements, process and method technical changes, robustness/ quality / productivity projectsManage product supply chain Integrated Risk Management… more
- Novo Nordisk Inc. (Boulder, CO)
- …Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for ... About the Department Our Research & Development organization brings together the best...merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... Scientist position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group… more
- Eisai, Inc (Exton, PA)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... want to hear from you.The Sr Mgr, GxP Systems Quality Assurance is responsible to help ensure Eisai is...procedures for GxP systems as assigned.Creates and updates change control management processes and procedures for GxP systems as… more
- Merck & Co. (Rahway, NJ)
- …Automation, Safety, Technical Services, Process Development, Analytical, Regulatory, and Quality .As part of Our Company's Manufacturing Division, within the ... identification and implementation of process changes for replenishment lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings.Design,… more
- Eisai, Inc (Exton, PA)
- …and OSHA guidelines.- Interacts cross-functionally with Production Operations, Facilities, R&D, Quality Assurance, Quality Control , Project Management, ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...be responsible for the creation and communication of the clinical and commercial supply plan for production of preclinical,… more
- Merck & Co. (Rahway, NJ)
- …GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables ... aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of… more
- Merck & Co. (North Wales, PA)
- …data is critical for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are complete and consistent. Having ... region with responsibility of meeting the reporting deadlines and quality measures specified in local SOPs- - Data Centric...with them. Accountable for maintaining a framework for regulatory control vocabularies ( eg SPOR) - Focu s on… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial… more
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