- Merck & Co. (Rahway, NJ)
- …and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the ... agencies for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... 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)
- …responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and ... and disseminate educational materials and initiatives related to quality concepts across global teams. Lead and inspire cross-functional QA teams to implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... immune disorders. SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists… more
- Merck & Co. (Rahway, NJ)
- …IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, ... with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices...local SOPs- - Data Centric Business System Owner Operations: Lead the regulatory data governance and standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under...cycle management of existing products. May serve as the lead regulatory representative on the project team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by partnering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to lead an efficient and effective organization Support the global quality annual objectives, strategic initiatives to deliver against the business plan.In ... 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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV… more
- Merck & Co. (Rahway, NJ)
- …Data Science, Experimentation, Financial Management, Financial Performance Management, Global Sourcing, GMP Compliance, Internal Communications, Lab Equipment ... Maintenance, Laboratory Management, Management Process, Personal Initiative, Pipeline Management, Regulatory Compliance, Reviewing Literature, Social Collaboration, Statistical Analysis {+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.- Lead internal and external (especially regulatory , but also expert… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Merck & Co. (Rahway, NJ)
- … lead , the Senior Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes ... PaCES lead to collaborate with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint… more
- Merck & Co. (Rahway, NJ)
- …company's Manufacturing Division product supply chain strategy in alignment with Global Human Health (GHH) brand/ franchise commercial goals.The Biologics VCM ... VCM Product Manager will be responsible for supporting supply chain design, global filing and launch strategy, long-range demand vs capacity planning, integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... 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
