- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead...in supplier oversight and governance meetings and lead processes improvement initiatives as required.Report to Director on… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating ... have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... 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. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the... trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships with external partners relevant to the design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg ... with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement ...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality… more
- Merck & Co. (Rahway, NJ)
- …to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... research activities.Identify opportunities for system optimization and drive continuous improvement initiatives to enhance data accessibility, usability, and performance.Stay… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies based on indication specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, and ... as other research areas centered around rare diseases and immune disorders. SummaryThe Director of Oncology Imaging Science and Oversight will be a member of the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , HEOR leads the execution of HEOR strategy and evidence development ... demonstrating the value of Insmed's product(s) for intended indication(s). The Director collaborates with stakeholders across the company including market access,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality...This role will also be responsible for trending of quality operations metrics and developing continuous improvement … more
- Merck & Co. (Rahway, NJ)
- …and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… more
- Eisai, Inc (Nutley, NJ)
- …training programs as well as evaluation of training outcomes (effectiveness and quality ) for continuous improvement . Define, monitor, and report on training ... training, advanced product training, improved selling skills, disease state knowledge, clinical and business acumen application of the Eisai Selling model and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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....and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit.… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... obtain all applicable source materialCollaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin Ops. etc. to ensure… more
