- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance. required Experience Qualifications4 or… more
- Merck & Co. (Rahway, NJ)
- …curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization with over 3,800 people operating in ... - May interact with internal and external stakeholders (eg, country operations , committees, vendors) in support of clinical study objectives. - Support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... service disruption is required.- Strategic Planning- Under the guidance of the Manager develop and implement business operational strategies that align with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a timely investigation and that protective solutions identified to avoid significant quality or patient. Execute all recall operations activities and process ... expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 regulatory lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and ... This position collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the business lead to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Financial Disbursements, that manages the day-to-day Financial Disbursement operations (Accounts Payable Processing, Travel and Expense Reimbursement and ... and accuracy of payments. Specifically, this role will be accountable for operations , suggest and collaborate with Financial Disbursement team members and global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Enrichment services, including data standardization, natural language processing o Data Quality operations that standardize data definitions, implements ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintaining innovative technology solutions for Meetings and Events, ensure smooth operations , and collaborating with vendors to optimize services and achieve ... define and manage service-level agreements (SLAs), ensuring compliance and high- quality service delivery- Monitor vendor performance, conduct regular evaluations,… more
- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory, commercial,… more
- Merck & Co. (Rahway, NJ)
- …Program requirements. Work collaboratively with various partner groups such as operations , equipment vendors, site maintenance, quality .Provide quality ... Job DescriptionPosition Description: Specialist, Sterile Engineer This Sterile Pharm Operations Engineer position will provide engineering support to sterile … more
- Merck & Co. (Rahway, NJ)
- …our Research & Development Division -Scientists, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. ... will function as the technical/engineering process lead engineer/project design manager with prior experience supporting Biologics, Vaccine and/or Sterile Projects.… more
- Merck & Co. (Rahway, NJ)
- …of the SDLC, excellent communication and collaboration skills, and a focus on quality and customer satisfaction.The Release Manager is responsible for the ... SAP Platform team has an opening for a Release Manager with experience in coordinating and managing releases, knowledge...solution being released is reliable and meets the necessary quality standards adhering to the IT release calendarSupport all… more
