- 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
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director, Clinical Research Scientist will support and work predominately with the Medical ... internal teams, CROs, and external vendors to prepare, review, and finalize clinical protocol documents.Contribute to scientific and operational aspects and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Senior clinical operational leader accountable for operational planning and ... for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality,… 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
- 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
- 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)
- …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
- 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
- Parexel (Trenton, NJ)
- …area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations ... and follow up of regulatory inspections. **Primary Duties:** Operational Quality Management : + Develop Risk Assessment...+ Minimum of 6 years of relevant experience in clinical research including at least 2 years… more
- Parexel (Trenton, NJ)
- …**Education:** - Bachelor's or master's degree. **Experience:** - 6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, ... in collaboration with Precision Medicine Companion Diagnostics Operations, Laboratory Managers and Clinical Laboratory Study Management . Expertise in one or more… 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
- Eisai, Inc (NJ)
- …of scan reconciliation and issue resolution in collaboration with imaging core labs, clinical operations, and data management , and contribute to tumor assessment ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...scientifically driven imaging expert with deep knowledge of Oncology clinical trials to shape the future of imaging science… more
- Merck & Co. (Rahway, NJ)
- …Design, GMP Compliance, Interpersonal Relationships, Lean Six Sigma (LSS), Management Process, Manufacturing, Manufacturing Process Validation, Operational ... Job DescriptionLocation:-Rahway, New JerseyDepartment:-Pharmaceutical Operations and Clinical Supply-Position OverviewJoin us at the forefront of pharmaceutical… more
- Insmed Incorporated (NJ)
- …early clinical development through product launch and life cycle management .Ensure HEOR strategies and tactics are cross-functionally aligned and meet the ... across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. This is… 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
- 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
