- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Merck & Co. (Durham, NC)
- …new facility will include end-to-end processing of drug substance, drug product , including biotech culture growth, harvest, lyophilization, product inspection, ... and warehouse.-As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility ... Hazardous Energy Control ProceduresCompliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines Effective maintenance, troubleshooting, and problem-solving… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety , data, CMC, IP, patient selection, ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to epidemiology strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, ... peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product . Research natural history of… more
- Eisai, Inc (NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... assigned therapeutic area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit feedback and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address ... for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all applicable regulations… more
- EY (Philadelphia, PA)
- …yourself, and a better working world for all.EY Comply - Financial Services - Senior Manager: This position could be located in PA, TX.EY is the only professional ... industry events that are reshaping and redefining the financial services industry. As a Senior Manager in EY Comply you will work primarily in one of our EY… more
- Honeywell (Atlanta, GA)
- …culture. Join the industry leader to design the next generation of breakthroughs! Senior Embedded Engineer within our next generation networked systems in Life ... Safety . This position will be a key end-to-end NPI...debugging and simulation tools which comply to customer, -cybersecurity, regulatory and industrialization requirements. You'll participate in the -applicable… more
- Cargill (Wayzata, MN)
- …to develop innovative products. **Job Purpose and Impact** The Cargill Bio Industrial (CBI) Product Safety Quality and Regulatory (PSQR) Regional Lead will ... product group and location strategies from a product safety , quality, and regulatory ...continuous improvement within the team. + Partner collaboratively with senior business stakeholders to proactively find solutions to new,… more
- AbbVie (Lake Bluff, IL)
- …presented for registration worldwide. The individual represents the organization at Senior level meetings regarding combination product and device labeling, ... combination product and device submissions and seek clarification on regulatory requirements; provide regulatory guidance and support to internal… more
- Abbott (Alameda, CA)
- …issue management program. + Ensure product safety issues and product associated events are reported to regulatory agencies. + Provide regulatory ... place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Operations Specialist** will work out of our Alameda, CA… more
- Staples (Framingham, MA)
- …operations, design, innovation, finance and more. The Senior Director of Quality, Product Safety and Regulatory Compliance leads a team of experts ... in quality, product safety , product regulatory compliance, and risk management. This individual sets the strategy and goals, provides coaching, training,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head, … more
- Abbott (Santa Clara, CA)
- … product submissions. + Ensure product safety issues and product -associated events are reported to regulatory agencies. + Provide regulatory input ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist** position is an on-site opportunity… more
