- 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
- Aequor (Newbury Park, CA)
- …processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… 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)
- …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)
- …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
- 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)
- …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
- Aequor (NJ)
- …/ Strong knowledge of the global drug development process and global regulatory requirements. Proficient and strong analytical skills. Strong communication ... 100 % remote Manager prefers local candidates (will consider non local...and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.… 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
- Merck & Co. (NE)
- …monitor over 5.5 million cows daily, which allows access to real-time, actionable data and insights to help improve or enhance animal management and health ... performance of animals and the people who care for them.The Territory Sales Manager - Livestock ID Infrastructure are responsible for establishing and driving the… more
- Catalent (St. Petersburg, FL)
- …continuous improvement and inspection readiness. Assess changes to GxP systems and data integrity regulatory requirements and communicate requirements to site ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… 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
- 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
- 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
- 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
- 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
- Lundbeck (St. Louis, MO)
- …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 ... and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We...us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the… 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
