- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of… more
- Merck & Co. (Rahway, NJ)
- … for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and ... and externally. Acts as primary site contact and site manager throughout all phases of a clinical ...and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Novo Nordisk Inc. (San Antonio, TX)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... services/tasks in support of the planning and execution of quality driven clinical trials in line with...staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance … 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to… more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...committed to a Patient First culture through excellence in quality and compliance , and to the safety… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... the Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy. A minimum of ... Corrective and Preventive Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...Essential Functions Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process improvement related to data governance to ensure data integrity, quality , consistency, and compliance with regulatory requirements.Define data governance ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems.… more
- Catalent (Harman, WV)
- Job Description: Manager , Supply Chain - WarehouseThe Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a ... on the way that the Harman's site operates. The Manager , Supply Chain - Warehouse will lead a shift...with other functional leads to improve operational performance and compliance will be a success factor for this role.This… more
- Merck & Co. (North Wales, PA)
- …of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy. A portion of ... in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information… more
- Aequor (Raleigh, NC)
- Remote Position - Flexible Hours Manager is open to seeing candidates with a minimum of 3&plus years of relevant working experience. Technical skills: advanced Excel ... (budgets), SharePoint, and Salesforce. Nice to have: clinical development process knowledge. Job Details: Manages one or more high-level, complex non-technical… more
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
