- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... accommodation.Education (from an accredited college or university)Bachelor's Degree in Computer Science , Life Science , Engineering, Information Technology,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Physical Requirements 0-10% overnight travel required. Qualifications A Bachelors degree required; Life Science and advanced degree preferred A minimum of 4 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and more innovative ways to improve their quality of life . We're changing lives for a living. Are you… more
- Pall (Miami, FL)
- …field or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO ... processes and/or procedures advises on impact of regulations, devises strategies for compliance , and liaison with regulatory bodies. Investigates and resolves … more
- Merck & Co. (Rahway, NJ)
- …monitoring and re-evaluation, participating in supplier audits, and addressing any quality and regulatory issues.- This role aims to ensure compliance with MDCP ... Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and guidance to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and industry standards concerning ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of... and Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... strategic initiative project teamsEducation and Minimum Requirement: BA/BS in Computer Science , Statistics, Applied Mathematics, Life Sciences, Engineering or… more
- Merck & Co. (Durham, NC)
- …biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline. Minimum of 4 years ... the contracted validation partners. Prioritize team safety, environmental, and compliance objectives. Lead, facilitate, and participate on cross-functional teams to… more
- Genmab (NJ)
- …and protocol deviations and is a key driver for inspection readiness, regulatory compliance , and successful data submissions.The Associate Director will lead ... or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance .Act as a Data Standards or Clinical Systems… more
- Eisai, Inc (Raleigh, NC)
- …to each potential negotiation. Requirements Undergraduate degree in Business Administration, Life Science , Supply Chain Management/Logistics, or bio-pharma ... science related undergraduate degree required. MBA or advanced life science degree preferred.10+ years working in product supply and/or logistics… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... matter expertise, a strong understanding of drug commercialization and the regulatory landscape.In this role, the successful candidate will be responsible toManage… more
- 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 ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Merck & Co. (North Wales, PA)
- …Data Management, Geography, Initiative Activity, Leadership, Lean Process Improvements, Life Science , Long Term Planning, Maintenance Strategy, Marketing, ... strategic initiative teams Education and Minimum Requirement :BA/BS in Computer Science , Statistics, Applied Mathematics, Life Sciences, Engineering or related… more
- Aequor (Aliquippa, PA)
- …and key-initiatives.Basic QualificationsMaster's Degree OR Bachelor's Degree and 2 years of Life Science or Business experience preferably in the biotechnology ... or pharmaceutical industry OR Associate's degree and 6 years of Life Science or Business experience preferably in the biotechnology or pharmaceutical industry OR… more
- Merck & Co. (Rahway, NJ)
- …ethics committees, and internal auditors in conjunction with CCQM, compliance , Regulatory , Pharmacovigilance (PV) and Medical Affairs.Responsible and ... and innovation-focused work environment.Builds a culture of quality and compliance through training, oversight, and collaboration.Oversight to ensure appropriate… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align...full Software Development Life Cycle (SDLC) for our custom MES, including detailed… more
- Merck & Co. (North Wales, PA)
- …initiative teams - Education and Minimum Requirement : BA/BS in Computer Science , Statistics, Applied Mathematics, Life Sciences, Engineering or related field ... SAS programming experience in a clinical trial environment MS in Computer Science , Statistics, Applied Mathematics, Life Sciences, Engineering or related field… more
- Merck & Co. (Rahway, NJ)
- …Requirement:B.S. /MS /Ph.D. in one of the relevant Engineering or Science fields.-Required Experience and Skills:Bachelors Degree in life sciences ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Aequor (Thousand Oaks, CA)
- …Services and Quality Systems teams to foster good communication throughout the project life cycle. 5. Ensure compliance - which includes implementing procedures ... for following through on multi-site action items. 13. May interact with regulatory agencies regarding area(s) of responsibility including written responses. 14. May… more
- Tris Pharma (Monmouth Junction, NJ)
- …products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
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