- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global ... other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM)… more
- Aequor (Newbury Park, CA)
- …and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...related to US/Ex-US regulatory submissions. In addition, this individual will be responsible… more
- Merck & Co. (North Wales, PA)
- … Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… more
- Russell Tobin & Associates (Dublin, OH)
- What are we looking for in our Transportation Project Manager ? PrideNow is seeking a Transportation Project Manager for an environmental, engineering, and ... to coordinate with Junior Engineers. As the Transportation Project Manager for the Great Lakes, this candidate will lead...on how our services can meet their needs Identify regulatory drivers for our services and build a plan… more
- Russell Tobin & Associates (Dublin, OH)
- What are we looking for in our Land Development Project Manager ? PrideNow is seeking a talented Land Development Project Manager to join an environmental ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to travel up to 10%Daiichi Sankyo, Inc. is an ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).Provide QA Technical support during the development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plan alignment. Other internal relationships include those with Medical, Sales, Regulatory , Legal, Market Access, Global Marketing and Global ... Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is an innovative, global healthcare leader committed to improving health and well-being in 140 countries around the world. Our product ... standard COMET platformEnable the continuous improvement and re-engineering of the global processes enabled by the COMET platform.Manage technical upgrades to keep… more
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... reports for the assigned product area, codes and enters information into the global safety database as requiredCreates and reviews individual and summary reports for… more
- Aequor (Austin, TX)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
