- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Specialist , Regulatory Operations - Submissions supports the development of submission plans ... tracked, archived, searchable and accessible. Enters and tracks project and submission data in Regulatory Information Management system (Vault RIM). With… more
- Merck & Co. (Rahway, NJ)
- …and communications stakeholders to refine, scope, and deliver technology solutions. Regulatory & Compliance Ensure technology solutions for communications comply ... communications capabilities, continuously reassessing priorities as new insights and data emerge. Discovery & User Research Lead ongoing discovery activities… more
- Merck & Co. (Rahway, NJ)
- …second shift.-Required Skills: Accountability, Accountability, Adaptability, Audits Compliance , Biochemistry, Chemistry, Clinical Development, Communication, Data ... Job DescriptionThe Rahway based Senior Specialist , Global Development Quality Operations, is responsible for...and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply… more
- Merck & Co. (Omaha, NE)
- …Documentations, External Liaison, Foreign Trade, Foreign Trade Policy, International Regulatory Compliance , Inventory Management, Key Performance Indicators ... Trials Operations, Communication, Compliance Policies, Customs Brokerage, Customs Compliance , Customs Documentation, Data Analysis, Data Management,… more
- Eisai, Inc (Cincinnati, OH)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic… more
- Eisai, Inc (San Jose, CA)
- …sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements preferred.Experience navigating ... cognitive impairment due to Alzheimer's disease (AD) or mild AD. The Neurology Account Specialist (NAS) will be part of a diverse team of sales professionals who… more
- Merck & Co. (Rahway, NJ)
- …clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & ... (FLEx) and new capital builds, including automation lifecycle management, data /analytics, and site representation on capital projects.- Some off-shift work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …utilities, and facility qualification, process validation, shipping validation, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight ... in supporting cell-based products is a plus.Strong knowledge of GxP compliance .Experience in cGMP regulatory body audits.Strong interpersonal and written/oral… more
- Cipla (Fall River, MA)
- …independently and as part of a team. Capable of handling and participating in compliance and regulatory audits at the local and federal levels. Experience in ... Job Title Packaging Specialist Organization Name InvaGen Pharmaceuticals, Inc. Location 927...operating procedures (SOPs) Monitor operational metrics such as efficiency, compliance rates, and resource utilization. Identify areas for improvement… more
- Cipla (Fall River, MA)
- …and root cause identification and analysis. Capable of handling and participating in compliance and regulatory audits at the local and federal levels. Must ... Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM… more
- Cipla (Fall River, MA)
- …and root cause identification and analysis. Capable of handling and participating in compliance and regulatory audits at the local and federal levels. Must ... is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … more
- Insmed Incorporated (NJ)
- …lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.Strong technical writing skills for authoring, reviewing and approving validation plans,… more
- Cipla (Reid, WI)
- …of equipment and products in compliance with site SOPs and regulatory guidance. Provides data to support management evaluation of performance trends. ... Job Title : Pkg. Documentation Specialist II FLSA Classification : Professional, Exempt Work...of a team. Capable of handling and participating in compliance and regulatory audits at the local… more
- Merck & Co. (North Wales, PA)
- …Launches, Product Lifecycle Management (PLM), Professional Networking, Project Management, Regulatory Compliance Consulting {+ 2 more}Preferred Skills: Current ... tools, requiring advanced problem-solving and critical thinking skills. Navigates regulatory , compliance , and operational constraints to deliver innovative… more
- BJC (St. Louis, MO)
- …development opportunities. * Participates in activities that promote safety, quality and regulatory compliance . * Collaborates with leadership to assess the ... Educator experience We are seeking an experienced and dedicated Clinical Education Specialist for our brand new Multidisciplinary ICU at Barnes Jewish Hospital. This… more
- Ochsner Health System (Kenner, LA)
- …* Completes timely quality control procedures in accordance with regulatory standards and performing notification/remediation as warranted. * Leads departmental ... any time. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including...being transmitted by Get It to the Employer, as data controller, through the Employer's data processor… more
- Merck & Co. (NC)
- …Projects, Productivity Improvements, Project Management, Project Management Engineering, Regulatory Compliance , Resource Forecasting, Root Cause Analysis ... Safety, Process Development, Technical Services, Utilities and Validation. The Utility Specialist Engineer is a member of the Plant Engineering team providing… more
- Merck & Co. (Durham, NC)
- …develop and constantly evolve security standards. Experience with computerized systems data integrity regulatory requirements, such as ALCOA+ principles ... Data Management, Digital Manufacturing, Global Team Collaboration, GMP Compliance , Machine Troubleshooting, Problem Management, Process Automations, Process Failure… more
