- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... change request; manage interactions with Vendor, finalize, and execute amendment.Audit Ready/ Inspection Prep: As per the audit requirement and processes, storage of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... The individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For… more
- Merck & Co. (North Wales, PA)
- Job Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to ... this Pipeline Advertisement you will be submitting your interest to...launch readiness across all strategic go-to-market launch components.Drive transparency, inspection and adaptation of launch plan progress - ensuring… more
- Genmab (NJ)
- …lab data, and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will ... data workflows.Lead or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance.Act as a Data Standards or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection… more
- Merck & Co. (Rahway, NJ)
- …to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality ... / cluster to deliver clinical trials as per global clinical research pipeline requirement.Strategic country / cluster representative for initiatives at all levels of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... study oversight and execution.Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.When sitting on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... applicable regulatory requirements, and other relevant guidelines.- Accountable for inspection readiness of laboratory data documentation filed/archived in Trial… more
- Merck & Co. (Rahway, NJ)
- …drive overall success and performance of the area and clinical pipeline .-Key Responsibilities:Prepares, operates, and cleans equipment and facilities used in ... containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP… more
- Merck & Co. (Rahway, NJ)
- …drive overall success and performance of the area and clinical pipeline .-Key Responsibilities:Prepares, operates, and cleans equipment and facilities used in ... containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems.… more
- Genmab (NJ)
- …the respective trial and the upload of documents as needed, etc.Ensure Audit/ Inspection readiness by conducting regular eTMF health checks, including monthly eTMF ... translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... applicable regulatory requirements, and other relevant guidelines. Accountable for inspection readiness of DM programming documentation filed/archived according to… more
- Merck & Co. (Rahway, NJ)
- …and regulatory filings Ensure smooth execution of PPQs and BLAs for pipeline assets Bring deep expertise in biologics DS processing (large molecule products) ... (cell culture and purification) Strong understanding of regulatory requirements and inspection readiness Ability to lead without authority, build trust, and inspire… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to ... inspections, such as those from Quality Events, Audits Findings and Regulatory Inspection (FDA/EMS/ PMDA etc.)Guide/advice RD, PV, MA business functions on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness.Stay current with emerging technologies and industry trends; lead… more
- AUROBINDO (Durham, NC)
- …affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife aims to provide healthcare at economical prices to ... corporate and data protection standards.Support internal and external regulatory inspection activities related tovalidated systems.Provide support to Quality Programs… more
- BioAgilytix (Durham, NC)
- …Harmonization Own End-to-End Sponsor Data Delivery: Direct the complete pipeline for extracting, transforming, validating, packaging, and securely transmitting data ... documentation is always ready for FDA, EMA, or sponsor inspection .Minimum Preferred QualificationsBachelor's degree in data science, Information Management, Computer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection readiness of all data management activities conducted internally or… more
- Novo Nordisk Inc. (Durham, NC)
- …diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. What we offer you: Leading ... extremely cold work environments. Occasionally positions oneself within confined spaces for inspection , repair & maintenance of equipment. Ability to work in loud… more
- Novo Nordisk Inc. (Durham, NC)
- …diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. What we offer you: Leading ... work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments… more
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