- Formation Bio (New York, NY)
- …extend product registrations. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and ... with the HA(s). Ability to read, analyze and interpret scientific and technical information and regulatory documents. Ability to present complex issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Merck & Co. (Rahway, NJ)
- …validation, with a strong understanding of quality management systems and regulatory compliance .Demonstrated technical leadership in injection molding, ... Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, Strategic Leadership, Technology TransferPreferred… more
- Merck & Co. (Millsboro, DE)
- …cycles and integrated fill-finish operations that affect product quality, throughput, and regulatory compliance .Act as the internal and external subject matter ... scientific experience and practical commercial manufacturing judgment. You will lead technical strategy, science-based technology transfer and scale-up of… more
- Merck & Co. (North Wales, PA)
- …and regulatory submission for our patients, partners, and colleagues.As a Technical Product Manager for the Compliance , Risk, Quality, & Vendor Management ... relevant work experience, with at least 3+ years of demonstrated Technical Product Management experience supporting Information Technology , Pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Merck & Co. (Rahway, NJ)
- … technical team.The Associate Director will lead a team of technical experts responsible providing Logistics and Distribution Technology Center of ... stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution Technology Center of ... stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology , Technical Product Leaders, and Value Chain to ... internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.--… more
- Merck & Co. (Rahway, NJ)
- …commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology , Technical Product Leaders, and Value Chain to ... internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.--… more
- Merck & Co. (Rahway, NJ)
- …the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical Project ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Merck & Co. (Rahway, NJ)
- …both development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project… more
- Merck & Co. (Rahway, NJ)
- …of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a ... industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environmentRequired:… more
- Insmed Incorporated (NJ)
- …(CSV) program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The ... building and protecting secure digital environments. The ideal candidate combines deep technical expertise with a proven ability to communicate complex risks in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coordinate and deliver comprehensive training programs that support clinical excellence, regulatory compliance , and medical affairs expertise across our global ... job reports to the Senior Director of the GxP Compliance & Technical Operations or the GxP...reviews of training programs to ensure relevance, accuracy, and regulatory compliance Implement quality improvement initiatives based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …commercialization, quality, analytical, regulatory , manufacturing, device development and technology , technical product leaders, and value chain to ... stakeholders, such as packaging and manufacturing sites, device development and technology teams, supply chain, operations, quality, analytical, regulatory , and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and growth. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the GxP Compliance , Patient Safety, ... e-learning platforms and tools to enhance learner engagement and efficiency Ensure technology solutions align with regulatory requirements and meet the… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology , to… more
- Merck & Co. (Rahway, NJ)
- …Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions, Technical Writing, Technology ... investigations, process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical … more
