- Merck & Co. (Rahway, NJ)
- …the Program CSPM designs strategic and operational plans for all clinical supply activities associated with the clinical stud ies in their assigned compound (s)/ pr ... & ensuring stable supply of product. - -- Primary activities include, but are not limited to: - -...for identifying significant supply risks associated with clinical bulk activities in addition to serving in a lead role… more
- Aequor (Athens, GA)
- …ensure systems are operating efficiently and safely. Engage in technical activities /troubleshooting related to the maintenance and repair of specialized equipment ... used in clean utilities. Ensure all maintenance activities comply with regulatory standards and safety protocols, including cleanliness of assigned facilities and… more
- Merck & Co. (Rahway, NJ)
- …Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned stud ies , which ... ensuring stable supply of product . - - Primary activities include, but are not limited to: - Participates...clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Insmed Incorporated (San Diego, CA)
- …the gene therapy clinical development team, and collaborates on other related activities performed by Clinical Operations and Medical Departments. This role provides ... strategic audit plan is developed, designed and implemented, and that the activities are conducted, and reports written according to SOPs and regulations.Oversee GCP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for US Medical Affairs Strategy and overseeing execution of medical activities for assigned indication(s) and asset(s) and will have the responsibility ... for managing budgets and resources for the assigned medical affairs plan activities , in collaboration with Sr. Director.- Leads medical readiness activities … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and audits direct report expense reports; manages and reviews time and activities (as collected and tracked in VEEVA) Reviews, evaluates, and channels information ... responses to requests from the Medical Liaisons for support of various activities from contacts in their respective region Management Actively manages the field… more
- Merck & Co. (North Wales, PA)
- …patients and global human health.This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. ... contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing… more
- Repligen (Hopkinton, IA)
- …inspections, operating manual and automated machinery, and completing packaging and labeling activities . The successful candidate will play a key role in ensuring ... quality, and production goals are met.ResponsibilitiesSupervise and coordinate the activities of production line workers.Enforce safety regulations and ensure the… more
- AUROBINDO (Durham, NC)
- …in.Job OverviewThe Warehouse Supervisor is responsible for all the daily receiving activities for APUSA. The Receiving Supervisor must ensure that all the ... for maintenance.Ensuring inventory transactions are accurately logged and reconciliation activities .Ensuring the dispensing of the Raw material and other components… more
- Merck & Co. (Rahway, NJ)
- …FDA process validation guidance) including various pipeline commercialization activities , process characterization, control strategy development, technology transfer ... this individual will support late stage and commercial large molecule biologics program activities . The individual will be responsible for leading a team to support… more
- Merck & Co. (Rahway, NJ)
- …(IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical supplies for their assigned studies. -The primary function of ... and balancing needs of patients & ensuring stable supply of product.Primary activities include, but are not limited to:-Participates on the Clinical Trial Team… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems. Responsibilities include ... fabrication, installation and verification Support person for process improvement activities ; including performing or authoring equipment specifications, user and… more
- Merck & Co. (Durham, NC)
- …EXPERTISE: The Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation ... and routine product activities to include the following:Sampling of clean utilities including but not limited to compressed gas and water for injection.Environmental… more
- Merck & Co. (Rahway, NJ)
- …development projects. Accountability predominantly includes submission data standards planning activities , coaching and consulting with project teams, outreach to ... statistical programming, statistics, regulatory and other project stakeholders. Primary Activities : PreNDA and PreBLA meeting preparation, study data standards plan,… more
- Merck & Co. (Rahway, NJ)
- …Product Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company ... platforms.Oversee and serve as an integrator of all device development activities including engineering design, engineering analysis and testing, medical device… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …N/A Essential Functions Product manufacturing and product manufacturing support activities Completion of routine documentation associated with the manufacture of ... product Support in-process activities and product development when instructed by supervisor Incorporate pre-planned process improvements/cost reduction program into… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Pharmaceutical Ingredient (API) Planning Associate will support completion of planning activities and PAS-X/SAP related projects. He/she will work with Planners, ... Production, Quality Control and Facilities to assist API Planning activities Ensure a smooth and effective flow of information...the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Other duties as assigned… more
- Merck & Co. (Rahway, NJ)
- …in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.The incumbent may initially work in a ... specific disease therapeutic area. Primary activities :Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution,… more
- Merck & Co. (North Wales, PA)
- …staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical ... team of staff assigned to the project as needed.-This includes the following activities :1. Is involved in late clinical development planning (LDP) to ensure that… more
- Merck & Co. (Rahway, NJ)
- …and summary reports.- Execute qualifications, validation, commissioning, and decommissioning activities .- Prepare Validation plans and annual reports around critical ... changes, execute periodic reviews and support Quality Management System (QMS) activities .- Interface with site & global engineering and maintenance groups, as… more
