- 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
- 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
- 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)
- …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
- 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)
- …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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …multiple large molecule programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA ... are developed by working teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing… more
- Merck & Co. (Rahway, NJ)
- …and adherence to our Policies, Rulebook Standards, and Specifications.Monitor the evolving global regulatory landscape, including tracking and analyzing new data ... lawmakers on industry best practices and requirements for effective global clinical research.Co- lead our network of 250+ Global Privacy Stewards who… more
- Merck & Co. (Rahway, NJ)
- …responsibilities are to oversee our company's customs country of origin program and lead efforts related to global customs origin reviews. CIT is primarily ... select trade compliance functions that are best performed on a global and/or cross-divisional level. Among other centralized trade compliance activities, CIT… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our Company's contribution to global medical innovation. - Enterprise IT (EIT) is an essential component ... Team, part of the EIT organization, owns our Company's SAP Global Template which enables enterprise-level capabilities through harmonized business processes and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a ... Review process change requests and deviation reports while ensuring regulatory compliance. Education and Minimum Requirements:Bachelor's degree in engineering,… 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)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.-... GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- …robust, and responsive supply.The individual will have a deep understanding of the global regulatory and business environment and the needs related to ... development and commercializationWorking knowledge of CMC filing requirements and regulatory guidances (eg, ICH) for drug substance and/or drug productExperience… 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
