- Aequor (Washington, DC)
- …- Fri 9 AM - 1 PM EST SCOPE OF RESPONSIBILITIES: accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team will be at ... ambiguity to drive decision-making working across teams DUTIES: Work with regulatory leads through cross-functional team support on both strategic and tactical… 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
- 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
- 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)
- …Research & Development organization at our company. Position Description/Summary The Senior Specialist , Project Manager is a core member of Early Drug Development ... and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- …Ensure that DP team is delivering in accordance to our Company's regulatory commitments, sustainability requirements and highest standards of quality. Coordinate and ... work closely with other work streams and Application Maintenance Services lead. Required Experience: Minimum 5 years of strong technical skills especially in ECC Procurement. SAP ECC or S/4HANA configuration experience. Good knowledge of Supply Chain 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. (Rahway, NJ)
- …produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a subject matter expert in CDISC ... with Health Authority regulations and guidance and company best practices.The Vocabulary Specialist is able to:Work independently, collaboratively as a member of a… 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)
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Executive Transportation Specialist Working in a dynamic, fast paced environment, the Executive Transportation Driver reports ... Director, Executive & Personnel Protection, Global Security.The Executive Transportation Specialist is an experienced professional responsible for the safe and… 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, ... applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships include… 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
- 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
- Catalent (Manassas, VA)
- …to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and maintaining the Quality ... track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and verify the operators' paperwork… more
- Aequor (Seattle, WA)
- …cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client ... Quality Council metric reporting. Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support… more
- Merck & Co. (Rahway, NJ)
- …in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report to the Director, ... CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Execute and develop appropriate system validation, change control, and… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Aequor (New Brunswick, NJ)
- …of documentation and address compliance concerns to meet GMP regulatory standards. Regularly review and prioritize customer equipment performance verification ... and support requests, responding promptly. Interact effectively with laboratory, Quality Assurance, and other departments as necessary. Interface with customers to ensure their expectations are met. Qualifications: 2-5 years of relevant experience in… more
