- 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, ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Merck & Co. (Rahway, NJ)
- …and updates country information in clinical and finance systems.Ownership of local regulatory and financial compliance . The position has a significant impact ... limited oversight from Sr.COM or manager.Requires strong understanding of local regulatory environment.Ability to proactively develop risk management and… 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 ... for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal Health Sites located in North… more
- Insmed Incorporated (Bridgewater, NJ)
- …risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit- ... drug safety partners, CROs, professional consultants, and /or contractors to ensure compliance with company policies and regulatory requirements on safety data… more
- Tris Pharma (Monmouth Junction, NJ)
- …safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams in ... Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify, evaluate and...but not limited to: safety data review, signal detection, risk communication including safety information updates, potential risks mitigation,… more
- Merck & Co. (Rahway, NJ)
- …(including the CTCs, CRAs and COMs).Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... and project management for assigned protocols in a country in compliance with-ICH/GCP and country regulations, Our Company policies and procedures, quality… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... area safety, compliance , production and financial goals are metSpare parts risk -based assessments and identification of new parts to replace obsolescent parts to… more
- Merck & Co. (North Wales, PA)
- …Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), other ... as needed.Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support of early-stage development to… 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. (North Wales, PA)
- …success in the assurance of deliverable quality and process compliance .Ability to anticipate stakeholder and regulatory requirements.Preferred Experience ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Catalent (San Diego, CA)
- …Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of audit activities… 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
- Merck & Co. (North Wales, PA)
- …position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across the ... manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer… more
- Merck & Co. (Durham, NC)
- …supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing ... operating procedures - that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture that ensures that… 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 ... Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, Medical Writers, etc.… more
- Novo Nordisk Inc. (Atlanta, GA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in line with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial… more
