- Aequor (TX)
- …NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of ... regulatory support, review and approval of applications with the...the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification… more
- Merck & Co. (Millsboro, DE)
- …tests, and review and release of antigen and seed batches. The QC associate specialist must adhere to regulatory and site policies and procedures governing the ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist , Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors,… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... are driving change. Are you ready to make a difference? The Position The Specialist , API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot Plant and is… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture… more
- Merck & Co. (Rahway, NJ)
- …CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other ... and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines.- Assisting with developing and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... Overview We are actively seeking a proficient SAP Master Data Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be responsible for ... and presentation skills.Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines which includes knowledge of Standard of Care/Routine Care and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global function on study and project teamsProduces independent writing for publications and regulatory documentsServes as a specialist in PK-PD and Pop PK-PD ... function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and… more
- Merck & Co. (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... data governance reviewsThe Global Clinical Data Standards (GCDS) Data Standards Specialist may contribute to the definition and maintenance of business processes… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing within the respective VMF's to include… more
- Merck & Co. (Durham, NC)
- …Durham employs 1,000+ people. This role as a Training Operations Associate Specialist will be an energetic individual with strong interpersonal, leadership, and ... manufacturing and related systems (ie SAP) Familiarity with pharmaceutical regulatory requirements Project management and data analysis skillsTechnical writing… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist , Manufacturing Automation (Hybrid) g, quality and engineering groups.- -Supports a large spectrum of sophisticated ... within Manufacturing Operations; providing multiple opportunities to learn new automatioThe Specialist is a member of the Focus Factory Automation team responsible… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics --Immune/Oncology-(QP2-IO)-team in the role of-Senior Specialist .--QP2-IO team is part of the Global Clinical Development ... senior scientists you will develop a comprehensive understanding of global regulatory expectations for small molecules and biologics, including support and authoring… more
- Merck & Co. (Durham, NC)
- …medicines and vaccines, including our HPV vaccines. - The Senior Engineering Specialist will troubleshoot and maintain process and process support equipment utilized ... plant maintenance and spare parts procurement systems. Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Ability to work… more
- Eisai, Inc (Nutley, NJ)
- …mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who ... sales/business analytics, etc.)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in driving growth and profitability, establishing… more
- BioAgilytix (Durham, NC)
- …data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the ... quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell...and more.We are looking for candidates who have practical regulatory experience with bioanalytical data in a corporate GxP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global function on study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK-PD and Pop PK-PD ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... The Position Novo Nordisk is seeking a highly motivated analytical support specialist to join the Analytical Development team in Boulder, CO. The candidate… more
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.The Senior Laboratory Automation Specialist will be primarily responsible for leading the programming and implementation ... liquid handlers, robotic arms, and automated assay platforms.Familiarity with regulatory requirements for laboratory operations, including GLP and GMP.Exceptional… more
