- 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
- 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. (Durham, NC)
- …currently Durham employs 1,000+ people. This role as a Training Operations 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 DescriptionThe main functions of the Specialist , Quality Assurance is to assist in the review of batch records, media batch release, investigations, support of ... .-Provide support to all Quality related audits from external and regulatory agencies .-Identify Continuous Process Improvements to maximize efficiencies and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionPosition Description: Specialist , Environmental, Health, and Safety (EHS) This position is part of our Company's Environmental, Health, and Safety ... - Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives.… 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: US Managed Markets Senior Specialist The Senior Specialist will work closely with US Commercial teams as a key financial and ... and growth of our Company' s Human Health business. The Senior Specialist is responsible for forecasting, month-end close, budgeting, and financial evaluation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Specialist , Environmental, Health, and Safety (EHS) As a member of the Site Environmental, Health, and Safety (EHS) team, work ... the Rahway site.Integrates EHS programs into daily operations to assure regulatory compliance, continuous improvement and performance objectives are met around EHS.… 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 overseeing the programming and ... liquid handlers, robotic arms, and automated assay platforms.Familiarity with regulatory requirements for laboratory operations, including GLP and GMP.Exceptional… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …performing and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all job duties and responsibilities in a compliant ... and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Other duties as assigned Physical Requirements While… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist , Lab Services - I, II, III as part of the Quality team based in ... Raritan, NJ. Role Overview The QC Specialist , Lab Services, is responsible for sample management. The...handle corrective and preventative action records. Supports internal and regulatory audits. Requirements A minimum of a Bachelor's degree… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and ... biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to be part of the team responsible for Warehouse activities that will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Advocate Aurora Health (Hartford, WI)
- …position of scan on all images.Maintains records in accordance with various regulatory agencies and enters patient and study information into the radiology ... unless department leader has determined it is not required, orVascular Specialist (RVS) registration issued by the Cardiovascular Credentialing International (CCI)… more
- Comhar Inc. (Philadelphia, PA)
- …in all meetings, task forces, advisory boards designated by regulatory bodies and/or COMHARRequirements:QUALIFICATIONS:Have a high school diploma or GEDHave ... Monday - Friday and some evenings and weekendsHave completed and passed a Peer Specialist certification program approved by the DepartmentWe are proud to be an EEO… more
- Jazz Pharmaceuticals (Indianapolis, IN)
- …of medical and product information in line with the company's policies, regulatory and legal requirementsAnalyze business in their designated territory to understand ... the company's ethical pharmaceutical marketing policies and proceduresComply with all legal/ regulatory guidelines of the Food, Drug and Cosmetic Act, the… more
- Jazz Pharmaceuticals (New York, NY)
- …required by Jazz.Execution of all activities within the defined Jazz regulatory and compliance program.Maintain company manuals, reports, computer systems, records, ... or similar coding certification preferred, not requiredPrior Authorization Certification Specialist (PACS) preferred, not requiredJazz Pharmaceuticals is an equal… more
