- Formation Bio (New York, NY)
- …manufacturing, packaging/labeling, and testing partners. Support the development and maintenance of Quality Agreements with external partners. Monitor CDMO and ... vendor performance and ensure timely resolution of quality issues. Oversee and perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements. Manage QA release of clinical trial materials to ensure availability for… more
- Formation Bio (New York, NY)
- …aspects of the quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry ... standards, and best practices in pharmaceutical manufacturing and defending it during health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements… more
- Formation Bio (New York, NY)
- …and systems grow.Responsibilities Infrastructure & Systems Administration Perform routine maintenance , updates, and optimizations on IT infrastructure and systems. ... Administer Windows and macOS endpoints using Jamf and Intune. Manage and support Google Workspace and ensure seamless integration with IT systems. Develop and maintain IT system documentation, policies, and best practices. Ensure compliance with IT security… more
- Merck & Co. (Rahway, NJ)
- …We're seeking a talented Technician to join our team. Provide mechanical maintenance support to facilities & utilities for Rahway, New Jersey pharmaceutical research ... campus and headquarters for our company.Support day-to-day preventative and corrective maintenance for assigned area(s) and may include technical input to mechanical… more
- Genmab (Plainsboro, NJ)
- …planning tasks, activities, and deliverablesGlobal Clinical Drug Supply:Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation ... SME knowledge supportCoach and mentor colleagues during onboarding and maintenance of trainingResponsible for oversight and resolution of deviations, CAPAs… more
- Tris Pharma (Monmouth Junction, NJ)
- …in ensuring efficient packaging of goods by performing packaging equipment maintenance including, but not limited to: troubleshooting, repair, upgrade, preventive ... maintenance (PM), etc. on various types of packaging equipment...& Responsibilities: Responsible for all aspects of Packaging equipment maintenance in accordance with company policies, SOPs, cGMPs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …patient support objectives for inline and launching brands Support the development and maintenance of SOPs and business rules related to all US patient support. ... Maintain program SOPs, exceptions processes, workflows, scripting, training and reports. Manage external partner performance against contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal… more
- Merck & Co. (Rahway, NJ)
- …Sponsor Standard Operating Procedures (SOPs) and applicable regulatory requirements.Support maintenance and archiving of paper and electronic study documentation as ... & mail, and ensuring the office environment is organized and well-maintained.Support maintenance of team SharePoint site.Assist with data entry tasks and quality… more
- Merck & Co. (Rahway, NJ)
- …is seeking an experienced Trademark Renewal Specialist to provide trademark maintenance and docketing support to the Intellectual Property (IP) organization. Primary ... amended trademark rules and docketing procedure to ensure all maintenance requirements are metAssist in operational excellence initiatives making appropriate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of routine office duties involving typing, invoicing, record and file maintenance , data entry, meeting/travel arrangements, planning and execution of either on ... or offsite department meetings, processing expense reports, department event planning (eg off sites, team building, group meetings), running reports, vendor management etc. Physical Requirements 0-10% overnight travel required. This role is required to be in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at a time, but example areas may include: Metrics and reporting through maintenance of data connections, data warehousing, and reporting within BI Platforms. Data ... analytics, detections, and automation through SIEM/SOAR content development and maintenance These functions require building and maintaining interfaces between… more
- Merck & Co. (Rahway, NJ)
- …and supporting work processes. - Ability to develop and implement effective maintenance strategies, including preventive and predictive maintenance programs that ... ensure the longevity and safety of facility equipment. - Demonstrated ability leading technical teams.- - Strong analytical skills to identify problems, evaluate potential solutions, and implement effective corrective actions. This includes troubleshooting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in improving Novo Nordisk infrastructure security Establishment and maintenance of relationships with internal security organizations (vendors, infrastructure, ... and security departments) Engage with Infrastructure Service Managers and Architects to improve Novo Nordisk infrastructure security Identify and communicate opportunities for improving Novo Nordisk infrastructure security Physical Requirements 0-5% overnight… more
- Merck & Co. (Rahway, NJ)
- …with GxP, GmP, and other highly complaint system implementation and maintenance best practices.Current Employees apply HERE Current Contingent Workers apply HERE ... US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We… more
- Genmab (Plainsboro, NJ)
- …serve a pivotal role at Genmab by contributing to the development and ongoing maintenance of key components of Genmab's Global Data Privacy Program. In this role, ... you will be responsible for two critical Program areas: (i) the design and implementation of privacy specific technical engineering and control strategies based on Genmab's data protection, privacy and data ethics regulations and policies; and (ii) the… more
- Merck & Co. (Rahway, NJ)
- …Experience with flow cytometers (eg, BD, Cytek) including maintenance , troubleshooting, and performance optimization.Data Analysis Skills:-Proficient in data ... analysis and interpretation, using software tools such as FlowJo, OMIQ, and FCS Express, with the capability to derive actionable insights from complex datasets.Regulatory Knowledge: Understanding of regulatory guidelines (FDA, EMA) pertaining to biomarker… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Regulatory experience required with a concentration in labeling development and maintenance Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected ... Requirements of Prescribing Information, FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations. An experienced professional having a wide range of experience… more
- Genmab (Plainsboro, NJ)
- …assigned project(s) and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile). ... For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, potential ROW submissions, supplemental BLA submissions, tracking of progress of PMRs… more
- Merck & Co. (Rahway, NJ)
- …Services: IFM, Real Estate, Office Supplies and Furniture, Industrial Gases, Maintenance Repair and Operations (MRO), and Archiving.The selected candidate will play ... a pivotal role in supporting both current and new business transformation projects within the CSS organization. You will bring the necessary discipline, execution, and implementation skills to facilitate numerous initiatives managed by the CSS team, while… more
- Merck & Co. (Rahway, NJ)
- …with IT teams for system configuration, infrastructure, and maintenance .Implement best practices, SOPs, Metrics, and continuous improvement for ... SAP operations.Team ManagementLead a team of -~125 employees, including global tech centers in Prague and Singapore and new tech center in India (2025)Provide leadership and coaching to global teams.Develop a multi-year digital capability roadmap aligned with… more
