- 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
- 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
- Merck & Co. (Rahway, NJ)
- …(QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and… 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
- 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)
- …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)
- …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 ... for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D… 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
- Eisai, Inc (Nutley, NJ)
- …obtained or related to adverse event reports, cumulative reports, or international regulatory reports and requests. 20%Set standards for data collection and ... and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with… 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
- 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
- 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
- Lundbeck (Bronx, 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 ... us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio...Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics,… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Eisai, Inc (Nutley, NJ)
- …2 years of work experience in Pharma in job offered or as Product Manager / Global Delivery Lead. Also requires 2 years of leadership experience with/using the ... following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes… 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
- 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
