- Novo Nordisk Inc. (WA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … of testing.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as ... of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Data Standards is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the Daiichi ... is processed through the appropriate levels of the Standards framework.Participate in review of Protocols, Global Clinical Libraries, Standards package, etc. to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working with Quality systems is required.Experience with quality support in clinical /commercial manufacture or NPI is preferred.Knowledge of ... tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will...1 year of leadership experience is also required.Experience in clinical quality , method development, cell banking, cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive continuous improvement.Have advanced computer ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …10 year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications Experience:10 or ... coordinate with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe CDT Program Manager is a member of the Clinical Database Testing Team.- As a member of the CDT Team the CDT Program Manager will be involved with ... the creation and execution of Quality Control and User Acceptance Testing procedures for electronic...and User Acceptance Testing procedures for electronic data capture systems , and the various components that make up the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and site selection meet study requirements Participate in the development and testing of clinical systems (eg, data capture, IxRS) Ensure internal and external ... negotiations with clinical sites and vendors as well as budget review and forecasting Independently manage interactions with clinical monitors, data… more
- Eisai, Inc (Nutley, NJ)
- …of study team members Assist with investigator meeting planning, including entering clinical meetings into Eisai internal systems Attend investigator meeting ... to hear from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of ...reconciliation and study file archival Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …internal audit process.Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue ... for the monthly CRB & quarterly QSMR presentations.Fulfills the Quality System audit module site key user... systems used to support audits/inspections.Provide support to quality systems team, ad hoc, for activities… more
- Merck & Co. (Rahway, NJ)
- …through on implementationStrategic view of project issues in a Quality Systems environmentStrongly developed cross-functional teamwork, collaboration, ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Merck & Co. (North Wales, PA)
- …the safety and efficacy claims of potential medical breakthroughs. Review the quality and reliability of clinical studies using deep scientific knowledge, ... statistical analysis and high- quality data to support decision making in ...projects (data, analyses, tables, graphics, listings); working with SAS systems and statistical databases; designing and developing complex programming… more
- Novo Nordisk Inc. (Omaha, NE)
- …cross-functional team environment required Advanced, in-depth understanding of US healthcare system , payers, reimbursement methods and integrated health systems ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Bothell, WA)
- …batch record reviews d. GMP incident/deviation review 2. Apply the principles of good quality systems and GMP, as assigned on a daily basis 3. Create and ... Performs review of validation documentation, periodic reviews of validated systems , and/or procedures, as assigned. Responsibilities 1. Compile and perform lot… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. ... and lead any remediation efforts. ResponsibilitiesLeads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory… more
- Novo Nordisk Inc. (Indianapolis, IN)
- …needs Coordinates with key internal stakeholders to provide customized and dedicated system -wide clinical education and support within respective IHNs and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … teams. Develop, implement and maintain SAS programming standards and performs quality checks. Review annotated case report forms and database structures.Develop ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions ... Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports… 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....with colleagues. Essential Functions Therapeutic Area: Assist Manager/Director in review of labeling for marketed products and new products… more
- Merck & Co. (Fort Wayne, IN)
- Job DescriptionThe-Senior Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education ... information and contract adherence in an effort to help the provider or system increase their immunization rates among appropriate patients and help protect them… more
