- 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
- 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
- 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. (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. (Rahway, NJ)
- …cross-functional partners including research and development, medical affairs, regulatory affairs, manufacturing, business development & licensing, market analytics, ... scientific communications, professional education, training and development, health care compliance to successfully navigate the internal and external environments… more
- Merck & Co. (Rahway, NJ)
- …not limited to:Responsible for preparation and review of US international tax compliance forms and disclosures (Forms 5471, 8858, 8865, 1118, 8991, 8992, ... reporting and filing of Form 8975 and Schedule AEnsure timely compliance for international requirements including, FBAR, FATCA and Pillar 2 reporting,Assist… more
- Merck & Co. (Rahway, NJ)
- …different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving ... organizational, prioritization and problem-solving skillsStay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals)… more
- Merck & Co. (Rahway, NJ)
- …vaccine programs.Interact with cross functional scientists including, Statistics, Clinical, Regulatory , QP2, CSRM, Data Management and Statistical Programming to ... appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders to identify areas for… more
- Merck & Co. (Rahway, NJ)
- …and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Execute and develop appropriate system validation, ... designing, implementing, and maintaining automated manufacturing process systems in compliance with industry regulations and standards. Your contribution will be… more
- Merck & Co. (Rahway, NJ)
- …collaborate with other SAP and non-SAP Business Areas, Digital Manufacturing Division, Compliance , our Research & Development Division Value Team, GSMG etc. Hold ... Ensure that DP team is delivering in accordance to our Company's regulatory commitments, sustainability requirements and highest standards of quality. Coordinate and… more
- Merck & Co. (Rahway, NJ)
- …improvement initiatives to enhance flexibility, efficiency, and compliance .Supports investigations and implementation of corrective/preventative actions.Positions ... : At least 2 years GMP manufacturing/processing experience.- Familiarity with regulatory requirements and Good Documentation Practices (GDP).- Experience with some… more
- Merck & Co. (Rahway, NJ)
- …the ability to work effectively with cross-functional teams.Familiarity with relevant regulatory guidelines and compliance requirements in the biopharmaceutical ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway site.Integrates EHS programs into daily operations to assure regulatory compliance , continuous improvement and performance objectives are met ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- …associated reference data to data collection and transformation specifications in compliance with Health Authority regulations and guidance and company best ... Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in industry, and our company's guidelines and… more
- Merck & Co. (Rahway, NJ)
- …/ co-lead activities as belowTarget product profile development, global regulatory filing strategy, launch readiness reviews, organized customer interactions, market ... P&L forecasting, BD&L activities, brand strategy, RWE development, promotion compliance reviewsDemonstrated ability to develop innovative and bold strategies both… 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
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… 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
- 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
