- Merck & Co. (Rahway, NJ)
- …business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide ... with a strong understanding of quality management systems and regulatory compliance .Exceptional project management skills and principled verbal… more
- Merck & Co. (Upper Gwynedd, PA)
- …with risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global ... Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process… more
- Merck & Co. (Rahway, NJ)
- … Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, Strategic ... within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas… more
- Merck & Co. (Rahway, NJ)
- …supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … more
- Merck & Co. (Rahway, NJ)
- …development.Knowledgeable of the Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across ... multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Durham, NC)
- …Meteorology, Mitigated Risks, Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (Rahway, NJ)
- …large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Aequor (Thousand Oaks, CA)
- …senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams… more
- Merck & Co. (Durham, NC)
- …years of experience in field calibration, metrology or equipment reliability. Project Management experienceFamiliarity of regulatory requirements in accordance ... leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our… 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
- Merck & Co. (Durham, NC)
- …a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while ... reliably supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality ,… more
- Merck & Co. (Rahway, NJ)
- …reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.Provides ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures ... database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are… more
