- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible...US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders… more
- Aequor (Thousand Oaks, CA)
- …DeviceResponsible for coordination, status reporting and stability of Combination Product Operations (CPO) project activities. Manages one or more ... Project Integrator * Candidate will be working primarily...program Core Teams, including subteams within the Combination Product Operations function, to ensure projects deliverables are completed on… more
- BioAgilytix (Durham, NC)
- The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information ... role requires close collaboration with both BioAgilytix's internal teams and the external project team, ensuring that all project workstreams are aligned, and… more
- Eisai, Inc (Raleigh, NC)
- …not limited to, Planning, Quality, and Operations to effectively challenge project deliverables and milestones.The Project Manager , Global Supply Chain ... is your profile, we want to hear from you.The Project Manager , Global Supply Chain is responsible...of critical timelines, changes to manufacturing processes, and upcoming regulatory filings. Project management, team leadership, and… more
- Merck & Co. (Upper Gwynedd, PA)
- …{CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality ... Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(PrM) will be responsible for managing a broad spectrum of PrM activities as project manager , which includes but not limited to plan/schedule, manage budget and ... position also responsible to identify improvement opportunities on the processes/ operations , drive cross-functional process excellence initiatives.Responsibilities:Coordinate PrM project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Manager as part of the Technical Operations team based ... in Raritan, NJ. Role OverviewThe CAR-T Operations Manager is an exempt level position...controls, and maintain permanent inspection readiness and actively support regulatory inspections. This individual will need to build strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business stakeholders to ... development, implementation, and maintenance of software systems that support business operations and objectives, with a special emphasis on HCP engagement systems.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... sensitive documents that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology systems, including… more
- Merck & Co. (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the ... concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Merck & Co. (Durham, NC)
- …participates in project suite teams, as required. Direct support of regulatory inspections and audits. Direct support of validation activities and all other ... as applicable. Contributes to the performance and results of the expansion project . Adapts plans and priorities to address resource and operational challenges.… more
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- … regulatory compliance and technical feasibility of proposed changes.Serve as project manager for the change process and provide coordination to ... myeloma.Legend Biotech is seeking Investigation Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR -T Investigation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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
- 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
- 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
