- Merck & Co. (North Wales, PA)
- …for higher complexity products including assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, ... Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and ... reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and… more
- Catalent (San Diego, CA)
- …Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San...include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Insmed Incorporated (Bridgewater, NJ)
- …to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.ResponsibilitiesAdditional representative ... other activities, as necessary.Participates and helps maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps ensure… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project team.Experience in regulatory compliance expectations across all phases of product development to ... of formulation, manufacturing processes, and packaging to enable phase-appropriate regulatory filings for oral products.- This research-based team contributes to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … task forces, who's goal is to assess impact and oversee the company's compliance with new and changed regulatory obligations related to Corporate Compliance ... accredited institution is required. A minimum of 10+ years combined pharmaceutical, legal, regulatory , and compliance experience required Or a minimum of 8 years… more
- Merck & Co. (Rahway, NJ)
- …influences site, region and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... collaborative relationships with stakeholders.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates… more
- Tris Pharma (Monmouth Junction, NJ)
- …Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems ... an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical Operations provides expert… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and ... ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP… more
- Novo Nordisk Inc. (Boulder, CO)
- …Lead on site emergency coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety ... with local regulatory agencies preferred Familiarity with technologies to ensure compliance The base compensation range for this position is $70,470 to $126,850.… more
- Merck & Co. (Rahway, NJ)
- …compliance councils. Key performance indicators range from quality and regulatory compliance , operational excellence, pipeline program support, financial, ... includes operating model, culture, talent development, technology introduction, and compliance .- However, one co-lead remains focused on non-sterile pipeline… more
- Merck & Co. (North Wales, PA)
- …teams in order to build partnerships and trust with Commercial Legal, Compliance , Privacy and Regulatory colleagues to effectively alleviate concerns and ... mitigate real/perceived risk from never before tried customer engagement capabilities and...with external start-ups and big tech partners and internal senior stakeholders to determine how tumor teams can capitalize… more
- Novo Nordisk Inc. (Boulder, CO)
- …Essential Functions Responsible for the manufacture of oligonucleotide API ensuring compliance to cGXP, safety, regulatory , and business processes and/or ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Catalent (Harman, WV)
- …evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards The Candidate ... quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, supplier quality, audits and inspections, raw materials… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the… more
