- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and compliance across clinical study safety reporting and activities.Global Clinical Study Start-Up Documentation : Reviews all clinical study ... immune disorders.Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops… more
- Merck & Co. (Rahway, NJ)
- …case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical ... Job DescriptionThe Trial Manager creates and ensures the successful execution of...responsible functional area.Ensures timely archival of trial data and documentation .Ensures timely decommissioning of clinical data management… more
- Eisai, Inc (Nutley, NJ)
- …timeframes and to assure consistency of case records and documentation .Responsible for evaluating, tracking, documenting and processing adverse event reports ... procedures, standardization of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information… more
- Eisai, Inc (NJ)
- …Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… 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 ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… 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 ... personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… 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
- Catalent (San Diego, CA)
- …, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... strategies for cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify data anomalies, inconsistencies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... and approval of standard operating procedures and any other required documentation . Collaborate with functional departments to resolve issues. Perform tasks in… 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 ... reported to management. Perform proper root cause analysis, identification, documentation , correction, corrective and preventive action, as appropriate Supports… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late stage ... clinical studies. Accountable for the control and reporting of...management.Special Projects/Change Management - Create and maintain up-to-date process documentation for all tasks; recommend and implement process improvements,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Merck & Co. (North Wales, PA)
- …review and final approval for all submissions and associated documentation . Provides expertise as worldwide regulatory representative to Product Development ... single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ... strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of...KQIs at the respective GPTs and prepare respective management documentation for the QA Head for review at the… more
- Aequor (West Chester, PA)
- Position Title: Sr. Manager , Global Scientific Communications Pay: /hr Bill: /hr Location: 145 Brandywine Parkway, West Chester PA Onsite or remote: West Chester ... Interpol, etc.) Drug TesT: 12 panel w/ Fentanyl Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
- Catalent (Manassas, VA)
- …2nd Shift is responsible for creating and maintaining the Quality System documentation . Communicate any deviations to management. Assist the Quality Assurance team ... is a site based positionThe Role:Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment. Reviews, ... inspection plan and record results to complete receipt process. Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.… more
