- Merck & Co. (Rahway, NJ)
- …Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies: ... Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to ... role will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical Research Associate)- Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review, Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… more
- Merck & Co. (Rahway, NJ)
- …CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of ... information and documentation in CTMS, eTMF and various other- systems as appropriate and per timelines.Supports audit/inspection activities as needed.Performs… more
- Novo Nordisk Inc. (Los Angeles, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …planning and conduct of clinical trials Demonstrated computer skills (MS Office, clinical trial systems ) and adaptability to new systems Excellent ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Novo Nordisk Inc. (Cincinnati, OH)
- …Pharmacy Staff (Pharmacist, District Managers, etc.) as well as health systems -based Clinical Pharmacists and Local Pharmacy Societies. Essential Functions ... you ready to realize your potential? The Position The Manager - Pharmacy Execution will work with Regional Business...products with local pharmacy colleges Medical Groups & Health Systems Partner with clinical pharmacists within local… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control, Client interface, Lab… more
- Lundbeck (New York, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the...with high influence customers in physician clinics, integrated health systems , infusion centers and alternative sites of care Product… more
- Catalent (St. Petersburg, FL)
- …and fiduciary policies, practices, and requirements.Collaborate with manufacturing, engineering, validation, information systems , QA, QC, and training to provide ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... the build of industry expertise in innovation and optimization for clinical trials.-Utilize strategic conferences for information mining and networking,… more
- Eisai, Inc (NJ)
- …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. ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US, EU preferred)2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred. Travel Ability ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA Product Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... they relate to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current… more
