- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Formation Bio (New York, NY)
- …quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and company policies. Establish and ... more
- Formation Bio (New York, NY)
- …teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key ... more
- Aequor (Atlanta, GA)
- …data appraisals in alignment with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidance. Review and summarize large clinical documents such as literature reports, clinical ... more
- Formation Bio (New York, NY)
- …regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines. Demonstrated experience with batch ... more
- Lundbeck (Chicago, IL)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …switches and databases. Job Responsibilities:Perform system administration (access control, software revision control, back-up and recovery), and troubleshooting for ... more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities for BAS, EMS and other automation and controls system software , hardware and associated interfaces inclusive of data management, issues, deviations, ... more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Lundbeck (Clackamas, OR)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... more
- Novo Nordisk Inc. (West Lebanon, IN)
- …site design standards for all IT platforms, including hardware, software and instrumentation standards Operational vendor management and contract negotiations ... more
- Tris Pharma (Monmouth Junction, NJ)
- …Authorization Application (MAAs)Performs statistical analyses using advanced methods and software (ie, SAS, R, etc.)Interprets and reports results of statistical ... more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry.Proficient computer skills to be able to navigate specialized software and databases.An ability to build strong partnerships and effectively ... more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Lundbeck (Nyack, NY)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational ... more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …industry, automotive industry, or similar rigorous production. Strong understanding of FDA regulations is a plus but not requiredProven experience in process ... more
- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... more
- Medtronic (Mounds View, MN)
- …excellence, compliance, and agile coordination, ensuring the delivery of high-quality, FDA -compliant software products. Navigate document needed for design ... more
- Bio-Techne (Wallingford, CT)
- …medical devices; knowledge of standards: GAMP 5, FDA GMP + Experience with FDA regulations for software validation and 21CFR compliance + Ensure that all ... more
