- Novo Nordisk Inc. (Durham, NC)
- …efforts. Identify and share better practices, to include increasing awareness of data management standards & validation to create improvements in methods, ... enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day...& initiative to understand the site process control systems, data management systems, and differing data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI ... of the DSI Call Center.Manage oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of data entry convention documents, PVA reviews and SAE flow plan / data management plan reviews. Works with ICSR management and CRO/Vendor oversight ... investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and… more
- Merck & Co. (Rahway, NJ)
- …Digital Strategy, Electrical Power Engineering, Engineering Design, Engineering Standards, Environmental Health and Safety (EHS) Management , HVAC Systems, ... self-sufficiency.3 years of experience leading multiple large-scale automation initiatives, including data management and data governance.Ability to work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …/oversight. PV experience/knowledge preferred Contracting process for PV vendors (eg Safety Data Exchange Agreement) Excellent interpersonal skills and ability ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Eisai, Inc (Nutley, NJ)
- …programming related technical and end user support to other areas of Data Operations, Data Management , Clinical Safety Data Review and Clinical team. ... of the essential Reports Manage the programming for Laboratory data management , conversion, normal ranges, & reconciliationManage Development… more
- Merck & Co. (Durham, NC)
- …the Master Data team with general Material Handling Steward tasksDrive safety , quality and process enhancements throughout the supply chain - Project ... Material(s):n/aRequired Skills:Business, Business Processes, Capital Planning, Clinical Supply Chain Management , Communication, Customer-Focused, Data Analysis, Financial Forecasting,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance… more
- Repligen (Rancho Dominguez, CA)
- …renovationsSupervise routine maintenance and repairs of building systemsEnsure compliance with health and safety regulationsDevelop and manage budgets for ... OverviewThe Facilities Engineer plays a crucial role in the maintenance and management of building systems and infrastructure. They are responsible for ensuring that… more
- Merck & Co. (Durham, NC)
- …Management , Data Management , Environmental Regulations, Environment Health and Safety , Fast-Paced Environments, GMP Compliance, Good Manufacturing ... will be-responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP,… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated ... Clinical Research, Clinical Testing, Clinical Trial Designs, Clinical Trials, Cost Management , Creativity, Data Management , Geography, Initiative Activity,… more
- Merck & Co. (Durham, NC)
- …Management , Good Manufacturing Practices (GMP), Maintenance Supervision, Occupational Safety and Health , Team Leadership, Troubleshooting, Vaccine ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Merck & Co. (North Wales, PA)
- …programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Business, Communication, Data Management , Data Modeling, Numerical… more
- Merck & Co. (Rahway, NJ)
- …trained and practice safe operating procedures in support of requirements.Ensure compliance ( Safety , Health , Environmental, GxP (as applicable), DOT, Labor, HR, ... systems. Manage the development and oversight of site operations through data analytics.Establish and monitor key performance indicators (KPIs) for HVAC system… more
- Merck & Co. (Durham, NC)
- …Industry, cGMP Compliance, Communication, Computer Literacy, Data Analysis, Environmental Health and Safety (EHS) Management , Lean Manufacturing Tools, ... to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This new facility will include… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab… more
- Eisai, Inc (Nutley, NJ)
- …of innovative strategies.Experience in managing and directing related functions such as data management , CRO vendor management , procurement, and ... healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... best science at first filing for parenteral development processes for human health while ensuing a phase appropriate approach during early development.The incumbent… more
- Merck & Co. (Millsboro, DE)
- …Aseptic Manufacturing, Cell Cultures, cGMP Compliance, Communication, Customer Relationship Management (CRM), Data Analysis, Employee Performance Standards, ... reliable supply to customers and patients on time, every time.Our Company's Animal Health , located at Millsboro, DE is a Biotechnology Center of Excellence that… more
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