- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have ... process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as ... and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Merck & Co. (Rahway, NJ)
- …Position Description: The Office of General Counsel is seeking an Associate Director , Trademark Operations to provide docketing and legal operations ... building, recruiting, staff development, training, and mentorshipExperience in legal operations , including strategic planning, project management , financial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,...clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross ... Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations , while ensuring the highest level of qualityCollaborate with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are PV relevant and AE… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to Clinical Operations , Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Merck & Co. (Rahway, NJ)
- … Director , Insights & Analytics is responsible for leveraging data -driven insights and advanced analytics to shape communication strategies, enhance stakeholder ... support the company's overall business objectives.From our company's owned channel platform data to social conversations outside the company, there are many data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design… more
- Merck & Co. (Rahway, NJ)
- …complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple ... Job Description Job Description: The GMP Operations branch of Biologics Analytical Research & Development...audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well as… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Insmed Incorporated (New York, NY)
- …and/or product support of appropriate prescribing, improved patient outcomes.Present data on Insmed products to HCPs including physicians, academic institutions, ... knowledge and competency of Insmed therapeutic disease states, products, and competitor data . Serve as a local medical and scientific resource to Insmed for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to medical coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym list. Coordinate ... with Data Operations Team on coding dictionary set...company specific synonym list. Responsible for the filing of Data Management coding documentation and approval/signatures forms… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... Coordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- AbbVie (Florham Park, NJ)
- …providers and CROs *Level is commensurate upon experience. There are 2 job openings: Director , Data Management Operations (Solid Tumor), Director ... execution and innovation. The Director of Clinical Data Strategy & Operations (CDSO) oversees the...organization. + Provide leadership and direction to the Clinical Data Management Operations team, ensuring… more
- CyrusOne (Totowa, NJ)
- …provide an exceptional customer experience each day for every customer. The Regional Operations Director oversees teams throughout the region to ensure proper ... To oversee the daily facility operations of all data centers within...practices and procedures. The Director will also provide Implementation Management support… more
- City of New York (New York, NY)
- Job Description TASK FORCE: Management & Operations JOB TITLE: One (1) Assistant Director of Management and Operations CONTROL CODE: MOT-24-01 ... fostering a more streamlined and responsive city government. Job Description: The Assistant Director of Management and Operations will provide leadership,… more
