- Merck & Co. (South San Francisco, CA)
- …positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with cloud-based data platforms and technologies ... leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused on bringing AI/ML approaches to bear to improve the… more
- Merck & Co. (Durham, NC)
- …the Durham sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities , Quality Labs, Material Management Storage Facility (MMSF) and projects ... a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes...in the pursuit of continuous improvement.Lead projects for a facility or the site .Able to train individuals… more
- Merck & Co. (Millsboro, DE)
- …committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities , along with our external contractors, suppliers, and partners, create an ... processing (water in oil emulsions, aseptic filling, lyophilization, etc.), the Millsboro site supplies and supports products for a wide range of species including… more
- Merck & Co. (Durham, NC)
- …the Durham sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities , Quality Labs, Material Management Storage Facility (MMSF) and ... technicians.Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the… more
- Merck & Co. (Rahway, NJ)
- …concepts, tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to ... and other disciplines to select and qualify new CMOs/CROs/CDMOsMust be available to work on- site at the Rahway, NJ facility . This is not a remote… more
- Merck & Co. (North Wales, PA)
- …clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in ... Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …teams Support facility certification for new Manufacturing (process equipment & facility -support equipment) and Quality Control facilities as needed as well ... About the Department Site New Hampshire, located in West Lebanon, is...Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will ... documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data … more
- Merck & Co. (Rahway, NJ)
- …scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in ... Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with the protocol in collaboration...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …equalization process to local finance, FP&A budget owners, and other stakeholders. Review and approval of payroll expenses intercompany cross-charged by local markets ... for expatriate employees on assignment in the United States. Review and approval of monthly journal entries to properly...ledger accounts and cost centers to obtain the relevant data , identify the employees and host entities, and prepare… more
- Merck & Co. (North Wales, PA)
- …of drug therapy as outlined in the OR planning process and generates data on a worldwide basis to support pricing and reimbursement.Develops value evidence ... dossier, health economic evaluations) and their adaptation to generate country-specific data supporting pricing and reimbursement.Works closely with the VT team… more
- Merck & Co. (Rahway, NJ)
- …further through to distribution and management of materials to the clinical site . The incumbent must have demonstrated understanding of E2E product development ... chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. -Responsible and accountable… more
- Merck & Co. (North Wales, PA)
- …knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and ... of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination, Statistical Programming, Research Laboratories scientists and Regulatory… more
- Merck & Co. (Rahway, NJ)
- …Late Development Statistics. --Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other company Research Laboratories Scientists in ... the clinical trial planning, execution, and reporting.Develops individual protocols and data analysis plans and determines appropriate statistical methodology for … more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP ... business risks, & influence portfolio decisions with facts and data - Demonstrates ability to balance strategy with ability...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Durham, NC)
- …state.Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.Troubleshoots ... GMP, and calibration/maintenance procedures.Uses the SAP work order system to review work requests, identify required stock and non-stock materials, ensure… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist, is a member of the Site Automation team responsible for the assigned process control systems in support of manufacturing ... will be-responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP,… more
- Merck & Co. (Rahway, NJ)
- …all information is comprehensive and well-documented.Independently collect and analyze data from internal departments, such as the Tax Department, Controller's ... divisions throughout our Company to support audit work and findings. Review and interpret IRS transcripts, focusing on payment and...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …Metrology and Validation Specialist position available at the Rahway, New Jersey research facility . The Metrology and Validation Specialist will work as part of the ... 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review , and approve documentation such as master inventory lists,… more
- Merck & Co. (Rahway, NJ)
- …the countries, that guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I staff globally in ... progressDrives global and regional symposia and educational meetingsSupports real-world evidence data generation and coordinates local data generation studies… more