- Novo Nordisk Inc. (Plainsboro, NJ)
- …within NNI Patient Safety Accountable for ensuring alignment with NNI PS / Global Patient Safety standards and processes as applicable Function as a Quality ... (PV) oversight. This role fulfills the PV Oversight for NNI Patient Safety processes and as providing SME-level input from the affiliate perspective when… more
- Eisai, Inc (Nutley, NJ)
- …the Safety Alert Reporting Departments, ensuring high-quality and timely global distribution of safety alerts and reports.Collaborate with IPTLs and ... is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects… more
- Merck & Co. (Rahway, NJ)
- …Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety Accountable for alignment between vendor assessment team and NNI Patient Safety Contracts and NNI Patient Safety / Global Patient Safety ... Interacts closely with Marketing & Patient Support Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved in the NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for the Patient Support programs database Manage IT projects in coordination with IT, Global Safety and Product Safety Management to upgrade and improve ... Brand Teams, Market Access, Finance, and other NNI and global stakeholders. External relationships include relations with external consultants,...the functioning of various safety systems Develop and manage project plan and timeline;… more
- Genmab (NJ)
- …approve the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of ... and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring...dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. ... 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
- Merck & Co. (Durham, NC)
- …dedicated to preserving and improving health, well-being, and performance.- We are a global team of Environmental Health and Safety (EHS) professionals working ... best practices, investigate and mitigate risks across environmental, health, safety , and sustainability (EHS&S) opportunities.- Ensure comprehensive change management… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Merck & Co. (Durham, NC)
- …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 ... local plant connected to our global manufacturing network to ensure the highest quality of...systems which enhances the operation and/or engineering processes.Quality & Safety Compliance:The successful candidate should be able to examine… more
- Merck & Co. (North Wales, PA)
- …of medical drugs and vaccines for the benefit of patients and global human health.This position supports statistical programming activities for multiple and/or late ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …projects. Interacts closely with Marketing & Patient Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved in the ... serves as Quality Point of Contact for PV Deviation process covering NNI Patient Safety Acts in the role of Deviation Responsible for NNI PV Deviation process,… more
- Merck & Co. (Rahway, NJ)
- …provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD ... and manipulationProgramming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic data (raw concentration data, derived PK parameters).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Merck & Co. (Millsboro, DE)
- …with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable ... component issues and work with vendors for resolutionEnsure proper safety procedures, standard operation procedures and aseptic techniques are followedReview… more
- Merck & Co. (Durham, NC)
- …Company Overview Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division is a team of dedicated, energetic individuals… more
- Merck & Co. (Durham, NC)
- …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 ... local plant connected to our global manufacturing network to ensure the highest quality of...as required . - Identifies and addresses compliance, environmental, safety , and process deviations as appropriate and escalates to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV and with CROs, vendors, and partners; and participates on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... improvement of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing… more
