- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with regulatory guidance (eg, FDA, EMA, NIH) on diversity and inclusion in clinical research . Establish best practices, training and resources for internal teams ... GCO Senior Director of Study Optimization has accountability for the oversight, management , and leadership of the operational enabling functions including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data ... within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.- Proactively identifies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Reporting ... Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and Reporting: Oversee ... experience in the pharmaceutical industry, with a focus on project management and operational support.In-depth knowledge of Health Authority expectations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years related professional experience required.Must have professional experience Project Management , Clinical Supply Management , and/or Clinical ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary: This is an operational position, task oriented in the execution of processes,… more
- Merck & Co. (Rahway, NJ)
- …that require advanced monitoring and connectivity.#EligibleforERPRequired Skills: Bioinformatics, Biomarker Research , Clinical Research , Clinical ... Research , Data Analytics, Database Architecture, Data Engineering, Data Management , Inventory ManagementPreferred Skills: Current Employees apply HERE Current… more
- Eisai, Inc (Nutley, NJ)
- …CSV and associated regulations.Proven experience in strategy development within area, operational management of quality processes through cross-functional teams, ... management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of...with teams to improve the effectiveness of the quality management system.Direct and oversee operational and budget… more
- Merck & Co. (Rahway, NJ)
- …Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal ... experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved… more
- Merck & Co. (Rahway, NJ)
- …Adaptability, Biopharmaceutical Industry, Business Intelligence (BI), Capital Projects, Category Management , Clinical Supply Chain Management , Collaboration ... Global Capital Procurement (GCP) team. This role is pivotal in providing operational support and ensuring the smooth functioning of our procurement processes.… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production ... members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and … more
- Merck & Co. (Rahway, NJ)
- …will encompass the entire lifecycle from early development through lifecycle management , providing critical technical strategic oversight and guidance across all ... partnerships span across multiple stakeholders and organizations within our Research and Development (R&D) and Manufacturing divisions.Interface with external… more
- Merck & Co. (Rahway, NJ)
- …and coach to the HF team and key stakeholders across R&D, clinical , regulatory, marketing, manufacturing, and quality functions.Educate and build awareness of HF ... HF domain (beyond combination products).Apply strategic planning, rigorous budget management , and sound scientific business decision-making to balance short-term … more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... The Associate Director/Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical… more
- Vitalief (New Brunswick, NJ)
- …efficiently and achieve sustainable growth. The Role We are seeking a highly experienced Clinical Research Operational Management Consultant to lead a ... visit (expenses covered) If you're a strategic thinker who thrives on solving complex operational challenges in clinical research , we'd love to hear from… more
- Mount Sinai Health System (New York, NY)
- …+ Strong knowledge of GCP, FDA regulations, and other applicable clinical research guidelines. + Exceptional project management skills with the ability to ... The **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration (CRSC)… more
- Mount Sinai Health System (New York, NY)
- …understanding of ethical and operational considerations in mental health clinical research , including work with vulnerable populations and cognitively ... for Psychiatry works closely with the Vice Chair for Clinical Research to support the coordination and...Clinical Trials Manager will work to ensure the operational success and regulatory compliance of a growing portfolio… more
