- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations . In their role, they will lead ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...well as engaging across NNI functions such as communications, training , finance, etc. This includes leading departmental meetings, agenda… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Functions Create job-specific training curricula for different roles within clinical operations , medical affairs, and regulatory affairs Maintain training ... The Position We are seeking a detail-oriented and passionate Training Manager to join our Clinical , Medical,...Senior Director of the GxP Compliance & Technical Operations or the GxP Compliance, Patient Safety, Vendor Oversight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports to the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP Compliance, Patient Safety, & Vendor Oversight. This job will ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...This job will lead a team of Patient Safety training and vendor training oversight managers 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 ... you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports to the Senior Director of the GxP Compliance & Technical Operations . This job will interact with Patient Safety, Quality, Vendor and Contract Management, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...This position combines the critical functions of patient safety training , compliance curriculum management, and vendor oversight to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports to the Senior Director of the GxP Compliance & Technical Operations or the GxP Compliance, Patient Safety, Vendor Oversight Director. This job will ... of L&D trends Serve as the primary liaison between senior leadership and the L&D function, advocating for strategic...(Master's degree preferred) 3+ years of experience in pharmaceutical training , clinical research, or regulatory affairs ATD… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the Director, Media & Stakeholder Relations, and interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), ... Commercial, Market Access and Public Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams as needed.… 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 ... oversight of Vendors and management of ICSR Verification teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides ... Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is… more
- Parexel (Trenton, NJ)
- …specific area of regulations (eg FDA, EMA, NMPA, etc.). As such, the Clinical Operations Manager (COM) is responsible for monitoring, interpreting and ... **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This...development and/ or revision of Client policies, SOPs and training materials. + Develops the strategy for management/support for… more
- Terumo Medical Corporation (Somerset, NJ)
- …device or life science roles of increasing responsibility including sales, marketing and operations and at least 8-10 years of senior management level ... Senior VP, Sales & Marketing - TIS Date:...places a premium on providing customers with world-class products, training and education programs that drive clear economic value,… more
- Parexel (Trenton, NJ)
- …through approval - Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical ) to meet key milestones - Conduct Regulatory Risk Assessments ... during IND/NDA review phases - Review and approve technical documents across Clinical , Nonclinical, and CMC domains - Monitor evolving regulations and translate… more
- Terumo Medical Corporation (Somerset, NJ)
- …industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical ... device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of… more
- CenterWell (Trenton, NJ)
- **Become a part of our caring community and help us put health first** The Senior Clinical Operations Training Professional provides training support ... and existing clinics across the US and participate in go-live support. The Senior Clinical Operations Training Professional collaborates with training… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …position in one of our office locations. Fully remote is not eligible._ The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …and outside the company on work that matters. #TechWithPurpose The PPD (TM) clinical research business of Thermo Fisher Scientific is a leading provider of global ... and government industries. Our Digital Solutions group is re-designing the clinical research model with purpose-built, CRO-owned technology integrated into every… more
- J&J Family of Companies (Titusville, NJ)
- …regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations , health economics, ... leadership teams on development plans or program-related issues + Working with global clinical operations , Regulatory, and Global Medical Safety, leads the … more
- Vitalief (New Brunswick, NJ)
- …that ultimately benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Financial Analyst to join our exceptional team ... carried out as outlined. + Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active … more
- J&J Family of Companies (Titusville, NJ)
- … development, clinical pharmacology, data science, digital health, global clinical operations , health economics, epidemiology, global medical affairs and ... in a Matrix environment is required. Ability to interface effectively with clinical operations , medical affairs and marketing is essential. **Required Technical… more
