- Eisai, Inc (Nutley, NJ)
- …mgmt. activities. #LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote-Based is from ... management and oversight of the Quality management system . This role is responsible for Good Clinical.../CQA conducting a broad range of audits.Experience with GxP systems including general knowledge of CSV and associated regulations.Proven… more
- Insmed Incorporated (NJ)
- …method validation/transfer, formulation work, and scale-up.Drive phase-appropriate quality system improvements for development-stage programs.Participate ... supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211,… more
- Merck & Co. (Rahway, NJ)
- …our external outreach to the scientific pharmacometrics community.Evaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support ... identifying and implementing novel quantitative approaches (for eg, comparator modeling, clinical trial simulations,- quantitative system pharmacology (QSP) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Eisai, Inc (NJ)
- …looking for a scientifically driven imaging expert with deep knowledge of Oncology clinical trials to shape the future of imaging science across its development ... of imaging acquisition strategies, biomarkers, and advanced analytics to support translational and clinical goals. At the same time, they will ensure data quality… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based ... the goal to contribute to the development and the communication of clinical , real-world, health economics outcomes data. This role primarily focuses on late-stage… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems , Microscopies, Negotiation, Optical Microscopy, Product ... Commercialization, Production Process Development, Project Management, Prototyping, Quality Management Systems (QMS), Self Motivation {+ 3 more}Preferred Skills:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director Medical Science Liaison will develop and maintain professional relationships with ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Bring together, synthesize and deliver HCP derived… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality ... to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to… more
- Insmed Incorporated (NJ)
- …a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Collect , synthesize and deliver HCP derived scientific ... to Insmed.Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments.This may include trial site… more
- BeOne Medicines (Pennington, NJ)
- …+ Health Authority Interaction/Audits + OE and/or LEAN Methodologies + Distributed Control system / Control Systems + Deviation Assessments / Investigations + ... role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities. **Essential Functions:** + Serve as MST… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Pharmaceutical Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance, ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production… more
- Integra LifeSciences (Plainsboro, NJ)
- …and execute CAPA project work which supports manufacturing operations and the Quality System . **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job ... with experience in process development and/or process engineering. + Experience with Quality System Regulation, Design Control and Process Validation guidelines,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Principal Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life cycle maintenance phases. The… more
- RWJBarnabas Health (West Orange, NJ)
- Director of System Clinical Quality PerformanceReq #:0000190918 Category: Quality / Patient Safety Status:Full-Time Shift:Day Facility:RWJBarnabas ... including the candidate's educational background, skills and professional experience. Job Overview: The System Quality Director will lead RWJBH system … more
- Thomas Edison State University (Trenton, NJ)
- …including beds, medication administration cart, etc.; - Collaborate with Clinical Learning Director to ensure high quality clinical experiences; and - ... **Experiential Learning Director ** **D27: $100,000 - $105,000** **W. Cary Edwards...mentors, educators, staff, students, and external partners to ensure high- quality , real-world learning experiences that enhance student competencies and… more
- CenterWell (Trenton, NJ)
- …with the Strategy Advancement and Operations Director to align clinical and operational priorities. ** Quality Improvement and Outcomes Management** + ... with best practices, regulatory standards, and organizational goals. + Monitor clinical quality , patient safety, and care outcomes, implementing evidence-based… more
- Atlantic Health System (Morristown, NJ)
- …Operation, ensure technical method/procedures are consistent with CAP and industry best practice system -wide Director of Quality , and the Medical Director ... The Technical Director supports the Clinical disciplines of...optimize lab performance + Integrate equipment, technology, and information systems to support operational efficiency and clinical … more
- Atlantic Health System (Morristown, NJ)
- System Medical Director , Neurosciences Service Line Atlantic Health System is seeking an accomplished and visionary System Medical Director of ... This physician leader will be responsible for driving the implementation of system -wide initiatives that enhance quality , innovation, and personalized care while… more
