- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of GCO including but not limited to GCO Leadership, GCO Study Management , CROs, Procurement, Legal, Compliance , Finance, Clinical Development, Global Project ... ensure full compliance with processes and requirements for investigator grant management and site payments. People Management & Resource Planning Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... required- Proven global line management expertise; experience of performance management and development of Director + level staff required- Proven experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is ... identifying the latest digital tools and technologies to support MCT activities. The Director serves as primary functional partner and MCT subject matter expert for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, oversight, and execution ... and implement a monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures as outlined… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct, reporting, and close out) including timeline, quality, and budget management Drives and leads the successful execution of all operational components ... global clinical program using strong clinical project and program management , leadership, decision-making ability, people management , and organizational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the ... high data quality and proactive detection and resolution of issues .Lead effective communications within the GPT, by interacting with...with other GxP QA functions (GMP/ IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV/MA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased ... as point of contact for cross-functional teams on global labeling issues . Based on timelines or resources, may assist another Global Labeling… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological ... part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible… more
- Merck & Co. (Rahway, NJ)
- …available which is accountable for all EHS program execution and compliance at our Manufacturing Division's Global Biologics Operations manufacturing facilities ... and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS performance objectives… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Director , Business Development Responsible for leading and executing business development and commercial activities which ... - functional areas (eg Finance, External Manufacturing, Supply Chain Management , Quality, Technology, Analytical, Commercialization and Operations), as well as… more
- Eisai, Inc (Nutley, NJ)
- …maintains reporting and validation testing standards for the department, and monitors compliance with these standards.Oversee data quality management process for ... from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that provides… 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 compliant ... cross functional scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the statistical analysis… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , Quality Operations ... Directors to ensure transparent communication and assess any product related issues . Impact assessment includes proper evaluation for Health Authority reporting… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working with the ... clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study.Provide medical expertise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key internal and external stakeholders communicating project status, escalating issues , and troubleshooting routine inquiries. Expert level written and verbal ... communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. Outside… more
- Lennar Homes (Morristown, NJ)
- …and monitors New Home Consultants paperwork to ensure accuracy and compliance with all division guidelines regulations and state/federal regulations. Ensure that ... NHC's are following up timely on all backlog issues and communicates any issues immediately to...special promotional events for Communities as directed by the Director of Sales and Marketing. Assists and/or conducts sales… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data ... Governance Stewardship will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all budget-related tracking, project management oversight, legal material review and process compliance , and other issues . Act as a champion and change agent ... role is an individual contributor role, and reports to the Director , Omnichannel Marketing.Responsibilities- Support experience journey design and implementation for… more
- Insmed Incorporated (Bridgewater, NJ)
- …York™, and Best Workplaces for Millennials™ lists.OverviewThis role supports the Sr. Director , Total Rewards to manage the US benefit plan administration. The ... and procedures. Requires monitoring of the various plans and policies to ensure compliance with legal requirements and company objectives. This is a hands-on role… more
