- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or part of a ... product safety team, and be responsible for overall ...may function as a key member of the Global Product Team in collaboration with Clinical Development ,… more
- Merck & Co. (Durham, NC)
- …vaccines to the patients around the world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support ... operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and qualification… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact ... in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company and clinical site investigators and KOLs Interface together with VP Medical/Scientific Development with Safety Review Committees and Data Safety ... About the Department Our East Coast Global Development Hub brings together the best minds in...help develop multiple products, including Dicerna's most advanced GalXC™ product candidate, DCR-PHXC, which is being created for the… more
- Merck & Co. (Durham, NC)
- …Leadership Skills and Inclusion. Provides guidance and makes decisions to ensure the safety of the employees is always maintained. Development and management of ... 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… more
- Merck & Co. (Rahway, NJ)
- …Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work ... a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director ,… more
- Merck & Co. (Rahway, NJ)
- …to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. ... culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions.- The Director , Biologics… more
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation and ... profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical...assigned therapeutic area to provide strategic input for the development of product strategies and liaises with… more
- Eisai, Inc (Nutley, NJ)
- …knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaise with external stakeholders to ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality… more
- Merck & Co. (Rahway, NJ)
- … development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate corporate ... investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Tris Pharma (Monmouth Junction, NJ)
- …is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...and PV issues Provides input and expertise to aggregate safety reports (ie, development safety … more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during ... new manufacturing technology/processes, training opportunities for improved manufacturing process development , and seamless technology transfer to commercial sites. The… more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... to establish and maintain a world-class team with expertise in complex sterile drug product development . In addition, to formulation and process development ,… more
- Merck & Co. (Rahway, NJ)
- …and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products ... release from our company to external agencies and investigators.Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position… 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 ... consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections...May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and… 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 ... reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems ... global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other ... under minimal supervision to solve complex project problems.Responsibilities- Protocol Development , Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
