- Merck & Co. (Rahway, NJ)
- …final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory ... by regulatory agencies for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …location of the congress.- Relationship ManagementCo- lead association relationship with Global Medical Affairs- Support all Programs Grants Committee (PGC) ... corporate goals and strengthen perceptions of the DS Oncology Portfolio.Responsibilities- Lead Global Oncology CongressesResponsible for the overall Global… more
- Merck & Co. (Rahway, NJ)
- …a skilled privacy professional to help drive our privacy strategy, implement our global privacy program , ensure compliance with global data protection ... Protection Board (PDPB), which provides overall governance and strategic oversight to the Global Privacy Program .Provide privacy support for new global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program ... programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …enterprise IT strategy.ResponsibilitiesStrategic Leadership, Platform management and Governance:Implement and lead the global strategy for process automation, ... 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
- Eisai, Inc (Nutley, NJ)
- …timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and committees. Qualifications ... guidance, and management of GRS teams responsible for large, late stage development program or for multiple early stage development programs . Using a hands… more
- Merck & Co. (Rahway, NJ)
- …are to oversee our company's customs country of origin program and lead efforts related to global customs origin reviews. CIT is primarily responsible ... 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 SPD Power BI Pipeline Tracker to help manage pipeline priority, metrics, program assignments, and resource utilization.Work with data science to manage the data, ... within SPDWorking closely with SPD leadership team to map resources to program needsManaging weekly escalation meetings, following up with staff on actions, and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interactions with Japan and Europe as required.Responsibilities- Lead the Global Finance and Procurement Capability Building Program - Design a comprehensive ... training program for Global Functional Skills Finance, Procurement, and other functions of...within US Finance and Procurement teams, as well as Global GCPM teams, CFO Leadership team- Lead … more
- Merck & Co. (Rahway, NJ)
- …are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for...teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager ( Program CSPM)… more
- Eisai, Inc (Nutley, NJ)
- …operations staff while strategically planning and managing multiple clinical development programs across different phases.The VP of Global Clinical Operations ... 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… more
- Merck & Co. (Rahway, NJ)
- …the ongoing management of our Company's vendor technology solutions related to Global Talent Acquisition processes.- This position will have a focus on the ... Global Talent Acquisition area specifically supporting our Phenom People...on appropriate system processes and procedures.Participates in projects and programs where functional processes are impacted, inclusive of mergers,… 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 ... study sites on the Dose Preparation Instructions. Seek input from other global functions as needed; proactively identify and resolve any technical, communication,… more
- Merck & Co. (Rahway, NJ)
- …to craft the project team's CDx (and associated DP if relevant) development strategy. Lead the selection of appropriate assays and Dx platforms for the execution of ... biomarker strategies. - Lead digital pathology efforts as needed for each individual...clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in global clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical safety and make a meaningful impact on clinical development at the program level. Lead projects to enhance processes within CSPV, including the CoE, ... 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)
- …support, or lead initiatives intended to expand the Daiichi Sankyo global development footprint or to promote globalization. The incumbent will also have direct ... for day-to-day Late-Stage Oncology business operations as decided by the Global Head of Late-Stage Oncology Development. Program Asset Transition Leadership:… more
- Merck & Co. (Rahway, NJ)
- …molecule programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly Core ... developed by working teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the ... 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)
- …The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs , and author or ... (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and thereby strengthening our pharmacometric capabilities on a continuous… more
