- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improvement initiatives. Reviews and provides input to SOPs, SOIs, and process guides. Clinical Study Start-Up Documentation : Reviews all clinical study ... on behalf of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical... documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Clinical Safety global business processes. This includes defining and...Technology.Develop &/or and manage process related artifacts (process maps, documentation , training content and role identification), ensuring alignment across… more
- Legend Biotech USA, Inc. (Charlotte, NC)
- …the treatment of multiple myeloma.Legend Biotech is seeking a Senior Cell Therapy Clinical Educator as part of the Commercial team based in the Carolina's territory ... (Remote/Field Based position in: NC, SC, WV, V).Role OverviewThe Cell Therapy Clinical Educator (CTCE) are field based commercial personnel responsible for providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct,...to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) ... locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager, of the following tasks:Global Clinical … more
- Genmab (NJ)
- …Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely ... delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management… more
- Aequor (Seattle, WA)
- …scientific strategies to ensure regulatory acceptance of biological assays in clinical development.Accountable for the generation, documentation , and analysis of ... potency assays to support the company's portfolio of preclinical and clinical -stage cell therapies. The ideal candidate will have a strong understanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(MedDRA and WHO Drug Coding dictionaries) including dictionary support documentation . Collaborates cross-functionally with the Medical, Clinical Development, ... of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality… more
- Aequor (Waltham, MA)
- …days 24 Hours per week The Occupational Health Nurse will provide critical clinical support to the R&D and Manufacturing operations to her assigned sites Individual ... (within scope of practice), treatment and case management for sites as assigned Clinical services at Occupational Health Center (s), sites as assigned (within scope… 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 ... for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios… more
- Merck & Co. (Rahway, NJ)
- …Company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and… 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 ... development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial-related, GxP, Compliance, etc.) across the US and Canada… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation ... of monitoring plan templates including review and annotation of monitoring-related documentation .Contribute to and support the oversight of the agreed RBQM strategy… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... development activities, compliance investigations/change management, and authoring of GMP documentation . The position is responsible for implementing actions to meet… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... operations, process development activities, compliance investigations/change management, authoring of GMP documentation , and lead other staff in the pilot plant as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical ... closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities ... sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.Work… more
- Insmed Incorporated (New York, NY)
- …expenses within assigned budget parameters Is accountable for the accurate and timely documentation of all activities This position will be based in New York Metro ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Aequor (South San Francisco, CA)
- …underlying toxicities that are observed non-clinically and / or in clinical trials through hypothesis driven research. This process involves closely collaborating ... safety assessment for our Client therapeutics spanning drug discovery through clinical development and marketing. The group provides fit-for-purpose wet lab-based… more
- Merck & Co. (North Wales, PA)
- …(MW&D) Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance ... in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers.The Senior Director of Global Health… more
