- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Pall (Miami, FL)
- …REQUIRED with a preferred relevant engineering major, Quality related field or material science fields with 15 years of progressive Regulatory compliance and / ... Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply to… more
- Formation Bio (New York, NY)
- …drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the ... values, and every team and individual plays a key part in our mission to bring new treatments to...commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling… more
- Merck & Co. (Durham, NC)
- …Aseptic manufacturing and GMP manufacturing experience. Strong planning, scheduling, and time management skills Working knowledge of regulatory requirements in ... we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you'll have the opportunity to collaborate with talented and… more
- Formation Bio (New York, NY)
- …principles of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory guidelines. About You Bachelor of Science Degree, as a ... industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...values, and every team and individual plays a key part in our mission to bring new treatments to… more
- Genmab (NJ)
- …experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart ... purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined...a meaningful impact in oncology drug development and be part of a dynamic, collaborative team that values innovation,… more
- Twist BioScience (South San Francisco, CA)
- …of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation: Oversee the full Software… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …developing and delivering high-quality safety evaluation related documents/deliverables on time .Coordinate and participate actively in safety-related regulatory ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible… more
- Merck & Co. (Rahway, NJ)
- …firsthand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative ... drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... and direct qualification activities to meet company goals, quality, and regulatory objectives. Qualification team will consist of managing external resources and… more
- Merck & Co. (Rahway, NJ)
- …Drug Substance Leader-to drive innovation and excellence across our Biologics Science & Technology (S&T) portfolio. In this high-impact role, you'll lead ... Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs...team, this is your moment. Join us and be part of a transformative journey in DS commercialization and… more
- Merck & Co. (Rahway, NJ)
- …Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives ... and re-evaluation, participating in supplier audits, and addressing any quality and regulatory issues.- This role aims to ensure compliance with MDCP current Good… more
- Beckman Coulter Diagnostics (Miami, FL)
- …Six Sigma, or equivalent credentials in quality or process improvement.Working knowledge of regulatory standards, including ISO 13485, 21 CFR Part 820, and other ... dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you...to meet quality, delivery and cost objectives.This position is part of the Global Supplier Quality team. The job… more
- Repligen (Waltham, MA)
- …on deal structures with regard to IP ownership, licensing, and regulatory compliance. Commercial Contracts:o Draft and negotiate commercial contracts, including ... contracts, and other strategic agreements.o Ensure compliance with applicable regulatory requirements and company policies. General Legal Support:o Partner with… more
- Lundbeck (Oakbrook, KY)
- …SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? ... brain health and transform lives. It's a very exciting time to join our team as we lead the...Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA… more
- Cepheid (Miami, FL)
- …This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality department and will be located in Sunnyvale, CA. At ... Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating … more
- Lundbeck (Fort Wayne, IN)
- …Muncie.SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being a curious, adaptable and ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (Memphis, TN)
- …SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable, and accountable? ... resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies… more
- Lundbeck (Oakland, CA)
- …SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Merck & Co. (Rahway, NJ)
- …first-hand - one of strong ethics & integrity, diversified experiences, exceptional science , and a resounding passion for improving human health through innovative ... drug delivery technologies and predictive analytical tools. As part of our global team, you will have the...external sites and be familiar with current industry and regulatory requirements on CCIT.This position will involve method troubleshooting,… more
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