- 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
- 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 ... and people with disabilitiesSummary 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)
- …improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy :Establishes Data ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… 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)
- …position will require proven skills in continuous improvement, project management , change management , and risk management . The position will act as main ... the development of study protocol (design, sample size, statistical analysis strategy ); Review CRF; Write SAP; Manage statistical analysis outputs with programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite and global strategy .Educate end-users on IT compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies, and contribute to the development and review of safety documents including Risk Management PlansEfficiency of Process, SOP: Leads the process and ... of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries out… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more
- Merck & Co. (Rahway, NJ)
- …and tools.Proactively resolve project obstacles and challenges and communicate device development strategy , design controls and risk management approaches ... manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and COM). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF ... DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP… more
- Merck & Co. (Rahway, NJ)
- …processes and procedures (internal and external).Working knowledge of design controls and risk management processes for medical devices and combination products, ... including establishment of design inputs, design outputs, design verification, and risk management integration. Expertise in testing, characterization, and… more
- Merck & Co. (Rahway, NJ)
- …including product development team, target product profile development, global regulatory filing strategy , launch readiness reviews, organized customer ... membersSupport the Global Asset Lead to develop the Integrated Business Strategy by actively synthesizing inputs from cross-functional teams including CORE, MA&P,… more
- Merck & Co. (Rahway, NJ)
- …Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and strategy , bridging the continuum from Discovery Research through Late-Stage Clinical ... early clinical space, determining and implementing the initial clinical strategy through proof-of-concept/pharmacology/principle and the transition from early to… more
- Merck & Co. (Rahway, NJ)
- …database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Eisai, Inc (Nutley, NJ)
- …study teams; Supporting Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such as ... Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes such as Submissions Management , Labelling, Publishing and… more
