- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the ... Operations .Collaborates internally with HQ functions, regional and local operations , EU Clinical Development, Pharmacovigilence, Global Medical Affairs to… more
- Merck & Co. (Rahway, NJ)
- …and mentoring to the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship program, while-properly managing situations ... of low or non-performance.The role will work across the different country operations roles (eg CRM( Clinical Research Manager), CRA( Clinical Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... service providers and working with internal departments to progress clinical supply projects. Every effort has been made to...the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with … more
- Merck & Co. (Rahway, NJ)
- …Has a deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Merck & Co. (Rahway, NJ)
- …design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies. Once the MACS Center ... a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Merck & Co. (Rahway, NJ)
- …overall IT Digital strategies - across the full technology stack across of Operations , Supply and Quality .- The resultant standard architecture must fulfill the ... product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations… more
- Merck & Co. (Rahway, NJ)
- …incumbent is responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP ... performing manufacturing, packaging, labeling, analytical testing, and distribution supporting the clinical supply chain on behalf of our company. Key activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global ... in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Merck & Co. (Rahway, NJ)
- …Sterile Production Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply.Once the facility is operational, duties will include ... operations specialist within in the FLEx Sterile GMP Clinical Manufacturing facility.To enable our Company's ever evolving pipeline... representatives, and other team members to ensure the quality of the clinical supplies, the scientific… more
- Merck & Co. (Rahway, NJ)
- …chemists, compliance representatives, safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately to ... interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies. -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites...our CMO's and internal packaging sites for GMP processing operations . This position will work with a label translation… more
- Merck & Co. (Rahway, NJ)
- …and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… more
