- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with corporate objectives and complies with local market regulations and standards .- Establish a consistent and standardized LinkedIn page experience across all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... meet strict regulatory requirements, industry best practices, and internal quality standards . The Lead is responsible for defining and driving the methodology,… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... rare diseases and immune disorders. Job Summary: This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV… more
- Genmab (NJ)
- …development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data summaries in ... the establishment and maintenance of Genmab SDTM and ADaM database standards .Performs database standards consistency checks on databases delivered by… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …resource allocation, ensure regulatory compliance, and uphold rigorous scientific standards . Understanding best industry practices, will identify opportunities for ... opportunities to develop additional revenue streams.Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to… more
- Repligen (Waltham, MA)
- …root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards . This role is based in Waltham, MA, and will report to the ... Notifications to ensure compliance with internal and regulatory quality standards .Coordinate cross-functional teams to assess and mitigate risks associated with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI Patient Safety Contracts and NNI Patient Safety/Global Patient Safety standards and processes as applicable Develops comprehensive, relevant resources (eg ... (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards (ie. Good Pharmacovigilance Practice (GVP), requirements Maintains proficient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety Accountable for ensuring alignment with NNI PS /Global Patient Safety standards and processes as applicable Function as a Quality Point of Contact ... regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding of the operational business laws and… more
- Repligen (Rancho Dominguez, CA)
- …Identify and implement process improvements, ensuring compliance with industry standards and regulations. Develop and maintain engineering documentation including ... Flat Sheet Membranes) Strong knowledge of ISO 9001 and GMP manufacturing standards . Proficient in SolidWorks/CAD, MS Office, and electronic file management systems.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... maintains oversight of PV relevant contracts. Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and equipment used at the site.Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards , industry ... standards , and global regulations.Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan SiteReview and approve change controls, SOPs, non-conformances, and CAPAs… more
- Tris Pharma (Monmouth Junction, NJ)
- …regulations, as well as all applicable company compliance guidelines, standards and objectives Leads and/or oversees functions (ie, purchasing/procurement, ... minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse operationsManages, coaches and mentors direct reportsRequirementsREQUIRED… more
- BioAgilytix (Durham, NC)
- …ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards :Develop a foundational data governance framework, with hands-on ... responsibility for data quality, access control, and compliance protocols.Define standards , build quality assurance processes, and monitor data integrity to meet… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities related to calibration and instrumentationEnsures proper materials, tools, standards , parts and spare parts are identified and availablePerforms work ... generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (eg EPA, OSHA and DEA)Experience in a growth environment managing… more
- Merck & Co. (Rahway, NJ)
- …viability of technology in proposed configuration, verify adherence to company standards and practices, and ensure deliverables are technically sound. Responsible ... deliverables. Participate in development and review of engineering guidelines, standards , safety/environmental policies, and change requests. Define intent in… more
- Twist BioScience (South San Francisco, CA)
- …MES, including detailed requirements gathering, system design, coding standards , development, rigorous testing, validation, deployment, and post-go-live support ... FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards . Oversee and execute comprehensive computer system validation (CSV) activities, including IQ,… more
- Novo Nordisk Inc. (Olathe, KS)
- …Obesity Establish Obesity as a chronic disease often requiring pharmacotherapy Use Standards of Care for Obesity Management to educate HCPs on appropriate ... importance of protocols to support the treatment of diabetes Appropriately present the Standards of Care for diabetes, including management of CV risk in patients… more
- Repligen (Clifton Park, NY)
- …to investigate alternatives, develop specifications, understands all applicable current safety standards , training standards as well as support writing technical ... efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based… more
- Formation Bio (New York, NY)
- …to support modularity, scalability, and cost-efficiency. Lead efforts to set standards on orchestration, compute strategy, access control, and CI/CD pipelines. ... Establish standards for data governance, observability, and metadata management. Ingestion...by the chance to mentor others, set high technical standards , and help an organization use data and AI… more
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