- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on plans for ... SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead) is fully...This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT… more
- Insmed Incorporated (NJ)
- …of credentials and experience . Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle management ... for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission… more
- Insmed Incorporated (NJ)
- …plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of clinical supply budgets and global ... (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics for global clinical programsDefine and implement comprehensive sourcing… more
- Merck & Co. (Upper Gwynedd, PA)
- …Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle of ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ensuring… more
- Insmed Incorporated (NJ)
- …a professional manner to executive audiences including attendance at requested meetings (ie, Global Clinical Team, Global Project Team, etc.)Who You ... Represents Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company… more
- Insmed Incorporated (NJ)
- …Medical Leadership, Medical Directors, Scientific Communications, Field Medical Excellence, Clinical Development , and Commercial Effectiveness to deliver high ... other, and for the future of science, we're in. Are you?About the Role:The Director , Global Medical Training Strategy will be responsible for developing the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company ... globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support Legend's regulatory program and monitor the ... Legend Biotech is a global biotechnology company dedicated to treating, and one...of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... your profile, we want to hear from you. The Director , Clinical Pharmacology actively contributes to multi-disciplinary...to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug … more
- Eisai, Inc (Nutley, NJ)
- …(QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection ... Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for...or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development… more
- Insmed Incorporated (NJ)
- … clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development , as well ... within assigned compound(s) Provides program-level programming leadership and support to clinical development teams Provides hands-on programming support to… more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... objectives: Develop, review, and revise departmental and corporate SOPs and processes.Provide clinical development and technical expertise in support of due… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development … more
- Eisai, Inc (Tampa, FL)
- …and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation ... and oncology, with a strong emphasis on research and development . Our history includes the development of...is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the physiology, pathophysiology and mechanism of action of Novo Nordisk compounds. The Director works closely with Research & Development teams to translate the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...US Operations. This individual will also work closely with global colleagues in Research & Development The… more
- Merck & Co. (Rahway, NJ)
- …strategy of partner scientific areas in conjunction with functional area and clinical development leadership.- For example, the Enabling Technologies team ... Job DescriptionOur Business Development & Licensing organization is a global...that grow our portfolio in meaningful ways. - The Director , Business Development & Licensing - Enabling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … global pharmacovigilance standards Physical Requirements 0-10% travel required. Development of People Supervisory. Verbiage below applies only to Supervisory ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… 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 ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... 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
