- 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
- 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 ... meet strict regulatory requirements, industry best practices, and internal quality standards . The Lead is responsible for defining and driving the methodology,… more
- Merck & Co. (Durham, NC)
- …Practices, Standard Operating Procedures and execute according to established safety standards .-Demonstrates, at all times, safe work habits and maintains a safe ... Office, Microsoft Office Support, Operations Management, Production Planning, Production Standards , Product Requirements Management, Safety Protocols, Safety Standards… 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
- Lundbeck (Indianapolis, IN)
- …Managing Execution Sets and maintains competent product knowledge and selling skills standards within the team. Directs and monitors the execution of approved ... and quality of work from self and others. Assures adherence to all standards , policies, procedures and guidelines as set forth by the organization. REQUIRED… 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
- 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
- Repligen (Hopkinton, IA)
- …equipment to ensure conformance to the organization and customer quality standards .ResponsibilitiesThe QC Inspector I will be responsible for:Conduct inspection of ... bioprocessing equipment, military or aerospace industry inspection practices and standards .Requires demonstrated use of basic Microsoft Office tools (Outlook, Excel,… more
- Merck & Co. (North Wales, PA)
- …and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.Maintain and ... mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.Ability to anticipate stakeholder requirements.** Preferred… more
- Merck & Co. (Durham, NC)
- …Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards , policies, and procedures related to EHS as well as industry ... assure continuous compliance with local, state and federal legislation, Company standards and industry best practices, investigate and mitigate risks across… 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
- Merck & Co. (Rahway, NJ)
- …source to analysis/modeling result. Support the development of programming standards to enable efficient and high-quality production of programming ... environment.Minimum requirement:Must have experience in CDISC SDTM and ADaM standards .Must possess programming expertise with clinical endpoint data (efficacy and… more
- Formation Bio (New York, NY)
- …regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for clinical trial endpoints Build scalable infrastructure for processing and ... with MRI and X-ray image analysis, including hands-on experience with DICOM standards and medical imaging software Strong programming skills in Python with expertise… 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
