- 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …principles of Quality by Design (QbD) as it directly relates to risk -based monitoring (RBM) and Central Monitoring.Responsibilities CRA Oversight and SME:Develop and ... implement a monitoring oversight strategy to ensure quality and compliance across the organization...the quality plan.Lead, participate, or support internal audit and regulatory inspection activities related to site monitoring and sponsor… 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)
- …standards.Proactively resolve project obstacles and challenges and communicate device development strategy , design controls and risk management approaches ... elements of combination product design, human factors, design controls and risk management , assembly processes and associated technology, characterization, and… 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)
- …relationships through all-phases of the trial.-Performs clinical study site management /monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local Laws & ... appropriately in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates… 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)
- …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)
- …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)
- …pro ducts to meet specific goals and objectives , including resource allocation, risk management , and portfolio optimization. - Develops and regularly calibrates ... levels of the organization. - Defines the overall product vision and strategy , emphasizing value, business outcome, and user experience. - Facilitates effective… 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
