- 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 for supporting the global regulatory lead (GRL), US … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with Regulatory Project Mangers to prepare labeling items consistent with content ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the… 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
- Aequor (Thousand Oaks, CA)
- Project Integrator * Candidate will be working primarily remotely, with possibility to work onsite * Bachelors Degree in Engineering * 5&plus years of experience ... coordination, status reporting and stability of Combination Product Operations (CPO) project activities. Manages one or more cross-functional projects of medium to… more
- Eisai, Inc (Raleigh, NC)
- …make a difference. If this is your profile, we want to hear from you.The Project Manager , Global Supply Chain is responsible for supply related projects and ... but not limited to, Planning, Quality, and Operations to effectively challenge project deliverables and milestones.The Project Manager , Global Supply… more
- Aequor (Thousand Oaks, CA)
- …activities for the AIN initiative Coordinate activities with Client and Regulatory transition team being built in IndiaCOMPETENCIES/SKILLS Project management ... and Workforce Strategy program that currently consists of the E2E Regulatory Content Automation and Regulatory India initiatives. Additional initiatives… more
- Merck & Co. (Durham, NC)
- …concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and ... finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer… 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 ... contract, keep project information up to date, liaison with internal and...organize, formulate and execute timelines for PrM projects including regulatory submission and publishing activities with a high degree… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Novo Nordisk Inc. (Boulder, CO)
- …dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is ... MS Project & PowerPoint Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing Proficient in generating and… more
