- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Daiichi Sankyo, Inc. (Bernards, 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
- BioAgilytix (Durham, NC)
- … frameworks, including FDA, GLP, GxP, and Part 11.o Partner with BioAgilytix's Quality and Regulatory teams to support validation, documentation, and audit ... orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by… more
- Eclaro (Forestdale, AL)
- …and willing to learn new computer systems. Dedicated commitment to providing superior customer service with a focus on quality . Must work well individually and ... Customer Service Rep Job Number: 24-03116 Find your next...putting together client paperwork, applications, and marketing materials. Within regulatory guidelines process applications for life insurance, long-term care… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).Support coordination of data collection and trend ... analysis as requested by QA and Regulatory Affairs including the annual report and continued process...for process changes/improvement.Provide technical expertise in the Technical Operations group , process knowledge of the cell and gene therapy… more
- BioAgilytix (Durham, NC)
- …orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by ... from planning to post-implementation support, with a strong focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the onsite… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in ... Excellence. The role also involves strategic partnering with Development Quality , Process Research & Development, Pharmaceutical Operations, and other parts… more
- Eclaro (Boxborough, MA)
- …Recovery/ Service Continuity, etc. Provide IT leadership to site regulatory inspection readiness and data integrity initiatives. Participate in high-level ... MA. ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality , innovative, and affordable medicines that make a difference in the lives… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …understanding of connectivity between the functions supporting the pipeline (ie- quality , regulatory , clinical development; chemistry, manufacturing, and control ... Description Principal Scientist Job Description The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Merck & Co. (Rahway, NJ)
- …in context of broader process and product development.-Deep working knowledge of regulatory guidance and quality standards, with experience authoring and ... and disruptive technologies and approaches.- Responsibilities include representing the group on product development teams and defining the potency...to have a minimum of twelve (12) months of service in current position prior to applying for open… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving ... Optimizes spend and ensures that resources are appropriately allocated, and qualities of service are maintained while costs remain on track and according to budget.… more
- Merck & Co. (Durham, NC)
- …embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- -Supports a large spectrum of sophisticated ... information technology systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or… more
- Merck & Co. (South San Francisco, CA)
- …drive in vivo pharmacology strategy and provide scientific/technical leadershipEnsure high- quality data generation, analysis, and reporting to project teams, ... governance committees, and regulatory agencies, and manage key timelines and milestonesLead and...and manage key timelines and milestonesLead and develop a group of PhD and non-PhD researchers, drive scientific innovation,… more
- Merck & Co. (South San Francisco, CA)
- …guide pharmacology strategy and provide scientific and technical leadershipEnsure high- quality data generation, analysis, and reporting to project teams, governance ... bodies, and regulatory agencies, and manage key timelines and milestonesLead and develop a group of PhD and non-PhD researchers, drive scientific innovation, and… more
- Eclaro (Huntington Woods, MI)
- …NJ. ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality , innovative, and affordable medicines that make a difference in the lives ... systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of… more
- Eclaro (North Potomac, MD)
- …mix of hands-on and management. Responsibilities: Overseeing all IT Operations and Service Delivery in a 24x7 support model. Extensive communications with clients, ... test events. Overseeing all Incident and Problem Management activities for IT Service disruptions. Track problems and resolutions from cradle to grave. Empowering a… more
