- Insmed Incorporated (San Diego, CA)
- … development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.Serve ... of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key… more
- 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; ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with...exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QC Microbiology Data Reviewer is an exempt level position with responsibilities for...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)
- …A minimum of 1 year of leadership experience is also required.Experience in clinical quality , method development, cell banking, cell therapy, or Research & ... required.Experience working with Quality systems is required.Experience with quality support in clinical /commercial manufacture or NPI is preferred.Knowledge… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... Lead (1st or 2nd shifts) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Aequor (Waltham, MA)
- … clinical materials for use in clinical trials Perform lot release Quality Review of manufacturing and quality control records to ensure compliance ... and/or 8&plus years of relevant experience Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) Working knowledge and ability to apply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …negotiations with clinical sites and vendors as well as budget review and forecasting Independently manage interactions with clinical monitors, data ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… 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...CDT SOP's and supporting documentation.May be responsible for compliance review and approval of CDT UAT documentation.Continually monitors for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Genmab (Plainsboro, NJ)
- …and in a compliant manner with colleagues in other functional areasEnsures optimal safety, clinical oversight and highest quality standards are applied to all US ... solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Aequor (MA)
- …manufacturing activities. Perform QA review of Executed Batch Records. Perform QA review of Quality Records, ie Deviations, CAPAs, OOS etc., as they occur. ... of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.... trials. Ensure all requirements, stipulated in the CMO Quality Agreements, are being met. Review and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality systems team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements.Develops and delivers training ... the treatment of multiple myeloma.Legend Biotech is seeking Sr. Quality Compliance Lead as part of the Quality...compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing ... various GMP activities supporting the production of clinical supplies with focus on analytical testing. Key activities this position would be responsible for… more
