- Merck & Co. (Rahway, NJ)
- …, Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, ... & Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on compliance auditing, risk assessment, and continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …to manufacturing, ensuring robust introduction, qualification, and performance monitoring. Regulatory Compliance :Collaborate closely with R&D and Manufacturing ... systems, including knowledge of damage mechanisms, common defects, and performance testing. Regulatory Compliance :Strong knowledge of relevant regulatory … more
- AUROBINDO (Durham, NC)
- …will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This ... and quality control.Ensure documentation is complete, accurate, and compliant with regulatory standards5. Compliance and Audit SupportParticipate in internal… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}Preferred Skills: Current ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (Rahway, NJ)
- …and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires ... and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and… more
- BioAgilytix (Durham, NC)
- …and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Merck & Co. (Rahway, NJ)
- …and Health, Pharmaceutical Guidelines, Process Safety, Project Human Resource Management, Regulatory Compliance , Safety Audits, Standards Compliance , ... protection and initiate appropriate action.Lead site and/or local area audits for compliance with applicable regulatory requirements (ie OSHA, EPA, DEP, etc.).… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical leader with ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Merck & Co. (Rahway, NJ)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Lead efforts to optimize call center workflows, implement ... internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance , Regulatory Requirements, Safety Standards, ... from the Operations Director.Works within budgetary/financial objectives set by Director- Compliance - Responsible for creating and sustaining a culture that… more
- BioAgilytix (Durham, NC)
- …to industry frameworks (NIST CSF, ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, ... and operational technology security (eg, segmentation, firewalls, secure remote access). Compliance frameworks and regulatory requirements (eg, ISO 27001,… more
- Merck & Co. (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical pharmacology… more
- Merck & Co. (Rahway, NJ)
- …preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful ... development and validationFamiliarity with authoring relevant CMC sections of regulatory submissionsRequired Skills: Accountability, Accountability, Adaptability, Analytical Chemistry, Analytical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot checks/internal audits.Collaborate with site personnel to… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsFoster… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …infrastructure, equipment, and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key member of the ... high-performing team of engineering and commissioning / qualification professionals.Ensure compliance with all applicable health, safety, environmental, and building… more
- Merck & Co. (Rahway, NJ)
- …Metrology, Oral Communications, Personal Initiative, Preventive Action, Project Reviews, Regulatory Compliance , Reviewing Literature {+ 4 more}Preferred Skills: ... Assurance and pilot plant support staff.Support internal and external compliance audit activities.Order and procure chemicals, solvents/solutions, materials as… more
- Merck & Co. (Durham, NC)
- …area/process overview information to visitors/auditors upon requestQuality & Safety Compliance :Foster strong safety culture on the team through actions, coaching, ... reporting safety issues and completing corrective/preventative actionsDrive culture of compliance through actions, consistent quality-driven decision making, and coaching… more
