- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on ... SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead)...This will include providing innovative strategies to continuously improve Global Clinical Operations quality and… more
- 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...across the organization with respect to CDSE deliverables and operations . External relationships include interactions with various vendors and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI and US Operations . This individual will also work closely with global colleagues in Research & Development The role will lead the development and execution ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...you ready to make a difference? The Position The Director , Real World Science leads the evidence strategy 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 Director Medical Review oversees a team of Medical Reviewers...key Leadership Team member and advisor on Patient Safety Operations including handling of all safety case processing activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scalability, automation, and continuous improvement. Relationships Reports to the Executive Director , PS & GxP Business Operations . Accountable for establishing ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...across US Quality, GxP Compliance Training and Patient Safety Operations . This role ensures that Safety/Quality/Training processes, systems, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work together to change lives for the better. The Position The Associate Director , Media Relations & Issues Management is accountable for establishing and leading ... potential to dramatically influence stakeholder perceptions. Relationships Reports to the Director , Media & Stakeholder Relations, and interacts with senior leaders… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Create job-specific training curricula for different roles within clinical operations , medical affairs, and regulatory affairs Maintain ... delivery in a highly regulated environment. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the GxP… 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 ... with SDEA requirements. Relationships This position reports to the Associate Director , Safety Contracts & Supplier Management. This position works closely with… 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 ... processing safety information and associated quality complaints (PQC) for US Operations (USO) post-marketed products. This role processes cases based on timelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction ... of the Senior Director , GMA Oncology ADC ( Global Medical Affairs...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will ... and risk management. Responsibilities Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships with ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …up, model the way and enable the team to act.Provides medical leadership to:- GMA clinical operations teams as part of evidence generation forums and study teams ... function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, and Global Product Team to inform … more
- BeOne Medicines (Pennington, NJ)
- …the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities. **Essential ... technical transfer, validation, investigation, and technical support of aseptic manufacturing operations in Hopewell and CMOs. Collaborate with Drug Product … more
- Sumitomo Pharma (Trenton, NJ)
- …our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The **Senior Director , Clinical Operations ** is a member of the ... global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused...Clinical Operations leadership team, responsible for Risk-Based Quality Management, Operational… more
- Bristol Myers Squibb (Princeton, NJ)
- …in a fast-paced, entrepreneurial environment. + Collaborate with the Executive Director Global Capital Project Engineering to ensure successful implementation ... at Bristol Myer Squibb provides strategic leadership for the Global Facilities Operations (GFO) Team overseeing a...talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …healthcare industry, with a strong background in HEOR, RWE, or clinical operations . + Proven track record of leading global evidence generation initiatives ... This position reports to the Senior Director , Global Integrated Evidence & Innovation Operations and can be based in Princeton, New Jersey. Otsuka… more
- J&J Family of Companies (Titusville, NJ)
- …data ecosystem. Working closely with Global Development Data Science teams, Clinical Development, Operations , and Regulatory stakeholders, as well as the ... company of Johnson & Johnson is recruiting for a ** Director ,** **R&D Data Science,** **Data Products -** ** Global...years of experience in pharma/biotech R&D with focus on clinical development, operations , regulatory, or data product… more
