- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Biostatistics and Data Management team and performs programming tasks, including SDTM… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data , CMC,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Preferred1 or more years of experience in a leadership role within Data Science in a Global Life Sciences organizationDemonstrated experience in the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …case processing workflow metrics including Case Handling Key Performance Indicator (KPI) data received from Global Safety to Patient Safety Management ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...(safety) SOPs. Collaborate with Global Safety on global SOP updates and regulatory changes Physical… more
- Lundbeck (New York, NY)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Merck & Co. (Rahway, NJ)
- …assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country ... requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …our company's Research Laboratories analytical, formulation and process development groups, Regulatory , Statistical Programming, Data Management, and with our ... analysis, and interpretation posed by scientists, Contract Research Organizations, and/or regulatory agencies.-May participate with manager in discussions with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. **Summary** The Regulatory Data Manager will be a key member of the ... Global Regulatory Affairs (GRA) Process...Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules… more
- Bank of America (New York, NY)
- …application of interpretation, data sourcing, preparation, governance, and oversight of Global Markets regulatory reports - with the overall goal of ... Global Markets Non-Financial Regulatory Reporting (GM...employees and clients, aligned to company D&I goals. + Manager of Process & Data : Demonstrates deep… more
