- Eisai, Inc (Nutley, NJ)
- …cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams on assigned trials. ... GCP Quality Assurance works within the Global Clinical Quality team to conduct GCP compliance activities at Eisai, at our CROs and Investigator Sites, and… more
- Merck & Co. (Upper Gwynedd, PA)
- …oncology products and supply chain design. The VCL will have major impact on cost, quality , customer service and compliance for the brands in their portfolio and ... at the place, at the right time.-The Value Chain Leader (VCL) is the primary point of contact between...and general knowledge of LEAN supply chain, regulatory, finance, quality and compliance , commercialization and life cycle… more
- Merck & Co. (Rahway, NJ)
- …regard for all of our Company divisional and local site procedures for safety, quality , and regulatory compliance - Understand the big picture, and how activities ... stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality , Operations, Product Development groups, Regulatory Affairs, Procurement, and… more
- Genmab (NJ)
- …(SDTM) standards that support the scientific need of a study/program while ensuring quality , consistency and compliance to CDISC standards and other industry ... oversight of relevant programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the… more
- Merck & Co. (North Wales, PA)
- …management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn ... Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Merck & Co. (Rahway, NJ)
- …candidates from development to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in our Manufacturing Division ... and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development ... advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Leica Biosystems (Miami, FL)
- …reports to the Manager, Quality Assurance and is part of the Quality Assurance and Regulatory Compliance Department located in Richmond, Illinois and will ... Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower… more
- Eisai, Inc (Nutley, NJ)
- …the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual ... This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of… more
