- Merck & Co. (Rahway, NJ)
- …potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary. The candidate ... including small molecules and peptides.- Within OFS, the Director will influence the strategy , lead activities, and develop a team whose roles include the design and… more
- Merck & Co. (Rahway, NJ)
- …applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills ... governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally… more
- Merck & Co. (Rahway, NJ)
- …plans, strategy development, launch and marketing execution and budget management .Ensure planning and readiness for senior business and strategy reviews ... input on such activities as: target product profile development, global regulatory filing strategy , labeling, launch readiness reviews, organized customer… more
- Merck & Co. (Rahway, NJ)
- …reporting relationship to functional groups in development, quality, safety, facilities management , analytical, finance and regulatory .-FLEx was designed to be ... assets in RY880, RY53, RY53 and RY80B.- This extends from materials management , weigh and dispense, GMP manufacture, formulation development, and bulk Drug Product… more
- Merck & Co. (Rahway, NJ)
- …(including the CTCs, CRAs and COMs).Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with-ICH/GCP and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist… more
- Merck & Co. (Rahway, NJ)
- …imaging tools, and data analy sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include: - Driving ... conferences, and publica tions as well as analytical technology and regulatory sciences related focus groups and consortia. - Qualifications Education Minimum… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical and Regulatory (CMR). Essential Functions Facilitates the creation and management of budgets and resource strategies within a VP Functional area of ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...a difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation… more
- Merck & Co. (Rahway, NJ)
- …executive vehicle.- Report any operational or mechanical issues immediately to management for action.- Maintain and evaluate safety equipment, and interior/exterior ... executive vehicle, reporting any operational or mechanical issues immediately to management for action. -Assists executives with the loading and unloading of… more
- Merck & Co. (Rahway, NJ)
- …(GI) cancer program; heavy emphasis on milestone communications ( regulatory approvals, data releases, medical meeting communications).Responsible for communication ... in alignment with the company's corporate narrative and Global Oncology business strategy while continuously partnering with Global & US Oncology marketing leaders… more
- Merck & Co. (Rahway, NJ)
- …scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems ... technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.--An established reputation for scientific… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy for the delivery of high quality and ... vaccine programs.Interact with cross functional scientists including, Statistics, Clinical, Regulatory , QP2, CSRM, Data Management and Statistical Programming… more
- Merck & Co. (Rahway, NJ)
- …and SAP Development.- They will also have responsibility for the end-to-end Upgrade strategy from roadmap to execution for the entire SAP Ecosystem (private cloud ... professional development opportunities to team members.SAP Basis DEV/OPSOversee the management and maintenance of the SAP technical infrastructure.Ensure system… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement, project management , change and risk management . Responsibilities - Leadership, Direction, and Strategy : Leads implementation of ... veterans and people with disabilities. Summary The Associate Director, External Data Management , is accountable for the end-to-end delivery of External data in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or ... people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy :Provides data ... project team regarding the data management DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level for a larger… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function. The respective Data ... Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and… more
- Tris Pharma (Monmouth Junction, NJ)
- …execution obligations Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue ... contractors Provides oversight and support to CRO Clinical Operations and Project Management areas ensuring ability to meet clinical, regulatory and business… more
