- 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
- Fidelity TalentSource LLC (Durham, NC)
- …or a closely related field and five (5) years of experience as a Senior Manager, Product Management (or closely related occupation) managing and executing large ... field and three (3) years of experience as a Senior Manager, Product Management (or closely related...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… 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
- Fidelity TalentSource LLC (Boston, MA)
- …or a closely related field and five (5) years of experience as a Senior Manager, Product Development (or closely related occupation) performing data analysis and ... or a closely related field and three (3) years of experience as a Senior Manager, Product Development (or closely related occupation) performing data analysis… more
- Fidelity TalentSource LLC (Merrimack, NH)
- …or a closely related field and five (5) years of experience as a Senior Manager, IT Product Management (or closely related occupation) performing Information ... field and three (3) years of experience as a Senior Manager, IT Product Management (or closely...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- Fidelity TalentSource LLC (Durham, NC)
- …Physics, or a closely related field and five (5) years of experience as a Senior Manager, IT Product Management (or a closely related occupation) performing IT ... field and three (3) years of experience as a Senior Manager, IT Product Management (or a...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- Fidelity TalentSource LLC (Durham, NC)
- … product mechanics, builds benefit administration systems, and maintains regulatory environment. Recommends designs for new systems based on requirements gathered ... work flow.Executes systems analysis for medium-sized projects.Analyzes project and product issues, and conducts troubleshooting.Establishes project plans for projects… more
- Fidelity TalentSource LLC (Smithfield, RI)
- …related field and three (3) years of experience as a Senior Software Engineer/Developer (or closely related occupation) building, testing, troubleshooting, and ... releasing product features within an Agile environment for database automation...field and one (1) year of experience as a Senior Software Engineer/Developer (or closely related occupation) building, testing,… more
- Fidelity TalentSource LLC (Durham, NC)
- …a Senior Systems Engineer (or closely related occupation) providing product support for Cloud applications and infrastructure within a financial services ... a Senior Systems Engineer (or closely related occupation) providing product support for Cloud applications and infrastructure within a financial services… more
- Fidelity TalentSource LLC (Westlake, TX)
- …flows, and plan level provisions is desiredProficient understanding of core product mechanics, record keeping systems and regulatory environmentCritical thinking ... Job Description:Business Analyst The RoleAs a Senior Business Analyst, you will join a team of passionate Health & Welfare professionals committed to crafting… more
