- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Clinical Literature MonitoringThe Director is responsible for the management and oversight of the day-to-day ... operations of the clinical literature information center, which is responsible for the...and maintenance databases and supporting systems to ensure optimum performance , reliability, data integrity, security, and awareness of the… 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 ... learn new indications required- Proven global line management expertise; experience of performance management and development of Director + level staff required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position will be the Head of Data Review Excellence in Clinical Science, reporting to the VP, Global Head of Clinical Science. He/she ... will be accountable for building and establishing the clinical data review standards across early and late-stage asset...listings, patient profiles and other documents to enhance data quality efforts. He/she will serve as the CS primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… 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 ... to do their bestOversee daily activity for the group to ensure quality results Performance management for direct reports.Responsible for and administers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies… more
- Insmed Incorporated (San Diego, CA)
- …(CSR) to ensure all studies are delivered on time, within budget and with high- quality data. Leads the cross-functional Clinical Study Team (CST), CRAs, CTAs, to ... mentorship to assigned study staff (CTMs, CTAs) or colleaguesReview metrics and Key Performance Indicators to ensure oversight of clinical trial progress.Manage … 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....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… 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....to maximize engagement and talent retention. Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
- 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...projects when required.Support project teams in the resolution of performance issues if escalated at a regional level.Collaborate with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group within the Chemical Engineering Research & Development ... job that provides a high degree of technical and management responsibility. -The Director - Automation Leader position will report to the Senior Director ,… 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....ready to make a difference? The Position The Executive Director , Real World Evidence (RWE), is responsible for assuring… more
- Merck & Co. (North Wales, PA)
- Job Description- Role Summary:The Process and Systems Lead Senior Director , Medical Operations (Lead, P&S) is a leadership role within Global Medical and Value ... Medical and Scientific Affairs (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead.-The Lead, P&S is responsible for managing… 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 ... the treatment of multiple myeloma. Legend Biotech is seeking Director , Quality Assurance as part of the...action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …will assist in driving the connection between the identification of Critical to Quality data and processes, the Risk Assessment, and Data Validation with the goal ... of creating a culture shift to data-driven data quality . This role will help drive the functional areas to adopt a data mindset that enables better data, for faster… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Global Oncology Value, Access, and Pricing (GOVAP) department. The Associate Director , Global Oncology RWE Generation will report directly to the Global Oncology ... as building and retaining institutional memory within Daiichi Sankyo. The Associate Director , Global Oncology RWE Generation will work in close collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Diagnostic Sciences will be responsible for end-to-end process for CDx ... implementation in clinical studies. They will ensure that sample testing and...scoring forms, and DTS documents.Develops and implements a testing quality monitoring program, ensures consistent data monitoring and output… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… 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