- 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
- Merck & Co. (North Wales, PA)
- …strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development...Development organization at our company. Position Description/Summary The Senior Specialist , Project Manager is a core member of Early… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …III as part of the Quality team based in Raritan, NJ. Role Overview The QC Specialist , Lab Services, is responsible for sample management . The QC Specialist ... to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively. Key Responsibilities… 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
- 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
- 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
- Aequor (Seattle, WA)
- …project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of cGMPs and domestic regulatory ... cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client… 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 ... of their assigned IDNsAccount / market dynamics, stakeholder mapping / management , the HCP referral process, access, account department drivers, patient pathway,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …instrumentation, automation PLCs, VFDs and electrical practices. Computerized maintenance management systems (CMMS). EHS and regulatory standards (eg ... of multiple myeloma. Legend Biotech is seeking a Metrology Specialist as part of the Maintenance & Metrologyteam based...review, approval and close out of work orders, including management of third-party vendor work, in accordance with established… 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
- 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 ... System documentation. Communicate any deviations to management . Assist the Quality Assurance team with special projects...data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and verify… 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, ... with databases, including querying structure/relationships/recursion, for data retrieval and management .Utilize programming languages such as Python or C to interact… 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
- 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 work, gene therapy and more.We are looking… more
- BioAgilytix (Boston, MA)
- …the patients who need them.We're seeking a detail-oriented and proactive Corporate Compliance Specialist to join our team. In this role, you'll play a crucial part ... hear from you!Essential ResponsibilitiesParticipates in the monitoring of the Quality Management Systems (QMS), including, but not limited to, Vendor Program,… 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
- 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
- Masonicare (Wallingford, CT)
- Regulatory Management Specialist Job Location: Wallingford Center, Connecticut Regulatory Management Specialist Masonicare Home Health & Hospice ... - Wallingford, CT Day Shift / 40hrs/wk Summary of Position: The Regulatory Management Specialist ensures regulatory activities are completed timely and… more
