- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Merck & Co. (Rahway, NJ)
- …a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles ... across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical ... talent across the organization and by applying overall and specific project management and organizational leadership expertise to the clinical development portfolio.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... through supplier selection and final contract execution on projects when required.Support project teams in the resolution of performance issues if escalated at a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Assoc Director OED - Supplies, is responsible for US and...Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Eisai, Inc (Nutley, NJ)
- …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 ... will be responsible for providing analytics support and recommendations to senior sales, marketing, and market access leadership regarding various initiatives,… more
- Merck & Co. (North Wales, PA)
- …work model (combination of in-office and work from home abilities).The-Associate Director , Digital & Omnichannel Innovation for US Oncology-focuses on digital health ... and may not be limited to: Strategically develop and deliver high quality digital health strategies and emerging customer experience and/or Omnichannel pilot… more
- Merck & Co. (Rahway, NJ)
- …environmental impact and advancing sustainability across its global operations. The Associate Director , renewable energy and carbon offset procurement lead will be a ... engagement, and stakeholder management, you will collaborate with cross-functional teams, senior stakeholders and our supplier network. You will lead the category… more
- Merck & Co. (Rahway, NJ)
- …siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, ... a matrixed reporting relationship to functional groups in development, quality , safety, facilities management, analytical, finance and regulatory.-FLEx was designed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the ... needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Merck & Co. (Rahway, NJ)
- …to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our ... to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inspection readiness components for the designated programs. Ensure proactive representation of Quality professionals at strategic project team and at GCP ... QA at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently… more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position ... will report to the Director , Engineering, Automation Lead position and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development… more
- Merck & Co. (Rahway, NJ)
- …Animal Health Operations in our Manufacturing DivisionDemonstrate robust portfolio and project management, assure adherence to financial budget targets and rapid ... leading a site program such as Manufacturing, Research, Tech Ops function, Quality or EHS Plant Leadership in pharmaceutical or chemical industryRobust skills… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management Drives and leads the successful execution of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …systems.Collaborate across functional teams consisting of internal customers such as Project Management, Site Operations, Validation, and Quality Assurance to ... Position Summary The Engineering Director is directly responsible for leading the Engineering...the operations and participate as a member of the Senior Management Team in developing site strategies and policies… more
