- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing ... resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI ... key therapeutic area opinion leaders, and organizations as well as professional service vendors. This role will oversee the portfolio strategy team with members… more
- Twist BioScience (South San Francisco, CA)
- …an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation , and optimization of our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation : Oversee the… more
- Insmed Incorporated (San Diego, CA)
- …a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations ... act as a Process Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the training of Manufacturing… more
- Eisai, Inc (Nutley, NJ)
- …buy and bill, GPO distribution and hospital P&T, landscape of infusion service reimbursement is preferred.Experience in development and implementation of brand ... want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the… more
- Merck & Co. (Durham, NC)
- …Calibration Engineer is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy ... This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into instrument events… more
- BioAgilytix (San Diego, CA)
- …and evaluating results. Identify new analytical techniques and technologies and lead their implementation .Review analytical instrument and equipment calibration, ... Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …metrology job plans and associated master plansParticipates in the development, implementation and sustainment of emergency response programs and other safety ... and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with… more
- Merck & Co. (Durham, NC)
- …Specialist, Calibration is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy ... This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into instrument events… more
- Merck & Co. (Rahway, NJ)
- …our company's divisions; - Manufacturing division, Global Workspace and Enterprise Services (GWES) and our research laboratories, Global Clinical Development for ... of our requirements and expectations in strategic sourcing.The successful implementation of this role requires developing direct relationships with internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships ... status meetings, monthly reporting and calibration calls Leads development and implementation of programs to ensure seamless and consistent patient experience across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk US Operations, including ED&AA, IT, Ethics and Compliance, Commercial, Patient Services , CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk ... AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI...tasked with providing strategy and vision on the technical implementation , optimization, and deployment of AI/ML pipelines, AI/GenAI models… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... review for phase III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position Responsible for the design and implementation of manufacturing processes, instrumentation, and equipment start-ups from the ... this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and… more
- USAA (Phoenix, AZ)
- …processes and programs while balancing operational efficiency, competitiveness, and regulatory compliance. Implementation may include overseeing business ... to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the… more
- USAA (Colorado Springs, CO)
- …to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the ... USAA, where our core values honesty, integrity, loyalty and service define how we treat each other and our...us special and impactful. The Opportunity The Data Scientist Lead will work closely with the Data Science Director… more
- Cytokinetics (South San Francisco, CA)
- …to development, regulatory , and registration strategies. He/she will support/ lead development and implementation of department policies. The individual ... requirements and industry standards are met. The Senior Director, Regulatory Affairs will lead the Global ...Health Authority interactions As the leader of the Global Regulatory Team, ensures the successful implementation and… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …in developing the translational biomarker strategy, and plans to secure implementation for Inflammatory diseases and IBD (Fibrostenotic CD), in the preclinical ... stages of discovery, clinical development, and post-market activities. Secure implementation and delivery of data and interpretation. ACCOUNTABILITIES Partner with… more
- Public Health Trust of Dade Co (Miami, FL)
- …(RCA), failure mode and effects analysis (FMEA) and monitoring of action plan implementation . Serve as a liaison with various regulatory agencies and entities ... Department : Jackson Memorial Hospital - Regulatory Affairs Address : 1611 NW 12th Ave,...required for patient safety and quality of care and services and promotion of continuous survey readiness. The incumbent… more
