- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc. and collaborate on required change control deliverables where applicable.Provide expert -level support for SAP MDG modules, addressing functional issues, ... objects and user guides, to ensure a comprehensive knowledge base.Manage and support all site-specific projects with respect to new product launches, alternate… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance Support ... sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good manufacturing practices (GMP) for drug products, active pharmaceutical… more
- Aequor (San Diego, CA)
- Expert Engineer - Automation/OT Hybrid San Diego site Pay range: - based on experience and qualificationsJob Description Summary: Provide technical support for ... local and global stakeholders and project schedules. Major accountabilities: Provide technical support and decommission for some/all of: o networking systems o SCADA… more
- Insmed Incorporated (Denver, CO)
- …Personal Health Information (PHI), with appropriate patient consent Serve as reimbursement expert for patient support services team for assigned geography/plans ... ourselves. In this field-based role you will have a unique opportunity to support patient access to prescribed treatment and deliver upon an industry leading patient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and participate in decisions for ISS proposals Assist with identification and support of National Leaders/National Expert Panels for select clinical trials, ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....Position The Medical Director serves as the subject matter expert for our products and related data within a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of studies; act as liaison with Regulatory, project teams, and investigators. Support recruitment & retention activities Obtain expert medical community input ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product life cycle. Collaborates with ... maintains roster, calendar, and minutes, and communicate materials, in support of the PSL. Independently evaluates safety data of...ensure timelines and business objectives are met. Subject matter expert (SME) in 2 or more focus areas. May… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... responsible person, the head of Patient Safety will act as the safety expert to establish and maintain processes, procedures and controls to ensure compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and ... business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets,… more
- Merck & Co. (Upper Gwynedd, PA)
- …activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under the guidance of the...and Preventive Action (CAPAs), worldwide.Acts as the subject matter expert and primary point of contact for relevant functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor for implementation and ongoing management and ... all system requirements for associated module(s).Serve as the Subject Matter Expert (SME) for respective modules to fully demonstrate knowledge and understanding… more
- Merck & Co. (Rahway, NJ)
- …processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support ... management and exert influence to achieve results. Regulations & Processes: Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated… more
- Christus Health (Beaumont, TX)
- …IS teams. Specific responsibilities include providing oversight for applications support including Incident, Problem, Request and Change Management. This position ... representation in phases of implementation including build, configuration, testing, go-live support , and optimization. Serves as escalation for the focus area in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited ... to Tech Support , Process Improvement, Validation, Supply Chain, Operations, QA, Reg...planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Design documents. Perform system customization and configuration work as needed to support new and existing functionality. Responsible for the development of the ... affect existing functionality. Responsible for production turnover. Resolve production support issues within established service level agreements. Provide project… more
- Merck & Co. (Rahway, NJ)
- …of experimental designs, execution of experimental plans and data analysis Support both early and late-stage development candidates, including screening and ... to define a robust formulation and manufacturing processRecognized as a technical expert and scientific contributor with proven ability to identify and develop… more
- Merck & Co. (Rahway, NJ)
- …of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within the company, providing input into research and business development ... within the organization; widely recognized within the organization as an expert in metabolic disorders and drug developmentDemonstrated ability to understand and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plans to address areas of concern. The Sr. Specialist will serve as primary support for EEO Investigators on complex EEO investigation, ensuring the accuracy of the ... Compliance, business leaders and employees. The Sr. Specialist leverages subject matter expert understanding of the application of EEO and affirmative action laws,… more
- Daiichi Sankyo, Inc. (Seattle, WA)
- …serve as a field-based, product access specialist that provides appropriate reimbursement support to HCPs to help facilitate patient access to DSI oncology products. ... The ADFR (FRM) will provide reimbursement education and support to oncologists and professional staff, and to respond appropriately to HCP questions regarding the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and ... Medical, Legal) as well as global market research and brand teams. Drive and/or support all US specific market research projects and oversee the work of support… more
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