- 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)
- … Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research , Clinical Research Management , Clinical Studies, ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines.… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team environment.Required Skills: Clinical Development, Clinical Medicine, Clinical Research Management , Clinical Studies, ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Merck & Co. (Rahway, NJ)
- … Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Research & Development Division ... GCS Planning (Planning) organization is the key interface between clinical development teams and the operational /executional arms...our depot network and further through to distribution and management of materials to the clinical site.… more
- Merck & Co. (Rahway, NJ)
- … Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's Research and Development ... globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational /executional arms within the… more
- Organon & Co. (Jersey City, NJ)
- …1 study operations + ICH/GCP + Clinical research + Clinical development + Vendor selection and management **Required Education, Experience and Skills** ... of TMED studies. **Responsibilities** + Manage and support the operational aspects of clinical studies from study...of contact for study-related vendors, including the study contract research organization (CRO) and/or clinical study sites… more
- Formation Bio (New York, NY)
- …role, you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the ... pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). ... MS/MPH preferred4 or More Years with PharmD/PhD preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical company, a… 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
- Merck & Co. (Rahway, NJ)
- …technology, business operations. Required Experience: 12 years of experience in Clinical Trial Operations, Data Management or related biopharmaceutical ... Business Administration, Business Management , Business Operations, Business Technology, Change Management , Clinical Data Management , Clinical Study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRaw Materials & Medical Device Director, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development ... analytical GMP activities partnering across the network to enable clinical supplies. In this role, the Director of the...The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Analytical Research & Development, Cell Based Sciences in Rahway, NJ is seeking a motivated senior level scientist with extensive experience in ... and effectively communicate with stakeholders in partner organization and to management and governance teams.Support regulatory filing by authoring and reviewing… 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
- 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
- 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
- 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
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our ... end cancer for life. The CMIO will partner with clinical and operational leaders to optimize existing...impact of changes from the distributed build programs. **Non-Epic Clinical Systems, Data, Research and Security** +… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our ... pressure-able to lead through change, engage front-line teams, and deliver strong clinical and operational outcomes. **Role Overview** **Strategic and Program… more
