- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study...allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships with external partners relevant to the planning and implementation of clinical trials improvement /innovation projects for NACD and Novo Nordisk ... with multiple internal stakeholders relevant to the planning and implementation of clinical trials improvement /innovation projects for NACD and Novo Nordisk (eg,… more
- Catalent (St. Petersburg, FL)
- …as well as support the clients with products that have technical opportunities for improvement . The QA Manager will act as an initial escalation decision maker ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment, Method Validation, Bulk Mfg… 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
- 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 ... 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
- 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
- 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
- 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 ... records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure compliance with… 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)
- …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
- 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 ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… 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
- 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
- MetroHealth (Cleveland, OH)
- ** Manager - Clinical Documentation Integrity & Improvement ** **Location:** **METROHEALTH MEDICAL CENTER** **Biweekly Hours:** **80.00** **Shift:** **40 ... or 3M 360 * CDIP (Certified Documentation Improvement Practitioner) - AHIMA * CCDS (Certified Clinical... Improvement Practitioner) - AHIMA * CCDS (Certified Clinical Documentation and Certification) - ACDIS Physical… more
- Milford Regional Medical Center (Milford, MA)
- …with dignity, compassion and respect. Statement of Purpose: The Manager of Clinical Documentation Improvement (CDI) is responsible for the leadership, ... clinicians and all levels of staff Extensive knowledge of official coding and clinical documentation guidelines Demonstrated skills in using encoder grouping and… more
- Kadlec (Richland, WA)
- …direction of the Clinical Resource Management Manager , the Clinical Documentation Improvement (CDI) Specialist coordinates and collaborates ... **Description** ** Clinical Documentation Specialist RN, Kadlec Regional Medical Center - Richland, WA** Under the general… more
- AdventHealth (Maitland, FL)
- …Documentation Improvement and all other operational hospital departments. The manager manages the Clinical Documentation Specialists (CDSs) in ... management of processes, system implementations, and project management. The Clinical Documentation Manager will report...plans when appropriate. + Serves as support for the Clinical Documentation Improvement Director providing… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Management Department (HIM) is seeking an enthusiastic leader to supervise our growing Clinical Documentation Improvement Program. Reporting to the Associate ... manage the operations and activities of the high-performing inpatient and outpatient Clinical Documentation Improvement Staff. Responsible for evaluating the… more
- Trinity Health (Livonia, MI)
- …on quality and CMI as well as ICD-10 coding systems and the guidelines related to Clinical Documentation Improvement . Serves as a resource for the CDS team ... + Certified Clinical Documentation Specialists (CCDS) or Certified Documentation Improvement Professional (CDIP) preferred Minimum of five (5) years of… more
