- 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …will be responsible for implementing and driving our Zero Trust security strategy across the organization, with a particular focus on Operational Technology (OT), ... Identity and Access Management (IAM), and Cloud Native technology.Responsibilities:Develop and lead the...and lead the implementation of the Zero Trust security strategy , ensuring the protection of our critical assets 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)
- …Director, Parasiticide portfolio Marketing will lead the brand and product portfolio management of Parasiticides, the marketing strategy , campaign, and key ... Director, Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and execution across markets throughout the world. It… 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)
- …of people management , leadership, and motivational skills.Superior stakeholder management skills across scientific, academic, regulatory , and scientific ... metabolism-associated liver diseases.Create, develop, and implement a successful Therapeutic Area strategy that will bring forth programs to successful approval and… more
- Merck & Co. (Rahway, NJ)
- …QP2 -IO on Oncology development teams. Framing critical questions and strategy for optimizing model-based analyses on programs. Developing and executing model-based ... proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring… more
- Merck & Co. (Rahway, NJ)
- …insights and recommendations that will help enhance global and regional strategy . The individual will proactively facilitate the identification and prioritization of ... intelligence programs (including annual budget planning) in support of strategy development. Maintain comprehensive and current understanding of relevant healthcare… 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)
- …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
- 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
- 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 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)
- …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
