- Novo Nordisk Inc. (Phoenix, AZ)
- …strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …setting required A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required Relevant Novo Nordisk ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help manage risk management ... Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management … more
- Merck & Co. (North Wales, PA)
- …Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality ... combination product .Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages team ... immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … across internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Effectiveness organization, primarily responsible for the successful development, delivery and management of comprehensive training (ie: product , skills, and ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, Commercial Learning & Development, will be a key member of… more
- Aequor (Thousand Oaks, CA)
- …clinical regulatory requirements, partner with key stakeholders to manage shipments of clinical drug product to clinical sites, globally. Key ... to document, investigate, and communicate decisions concerning distribution complaints. Sales Order Management : - Create and manage Clinical Drug Shipments in an… more
- Merck & Co. (Rahway, NJ)
- …to be programmed; an understanding of statistical terminology and concepts.Familiarity with clinical data management concepts.Hands on experience in CDISC and ... potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the development of… more
- Aequor (Thousand Oaks, CA)
- …processes that increase the Corporate Transportation value proposition with minimum management direction Responsibilities Execute GDP/ GMP and business processes in ... Develop and maintain key performance indicators (KPI's) and metrics for area management Develop and maintain training materials related to the NA-TO Back Office… more
- Merck & Co. (North Wales, PA)
- …systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine ... collaborate to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and analytics ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead ... is responsible for the management of technology transfer of the manufacturing processes of...of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply ... Operations (shipping, receiving, inventory control, customs clearance, supply / device management ) Responsible to ensure timely availability of clinical study… more
- Merck & Co. (Rahway, NJ)
- …with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance Management .Understanding of regulatory and clinical processes for pharmaceutical ... Corporate Business Development, our Research & Development Division Global Alliance Management , Integration Management Office (IMO) and GRACS Business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and ... around rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development, integration, and execution… more
