Job Description: We are seeking an experienced Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and manufacturing environments. This role demands a s...
Job Description: We are seeking a highly motivated Scientist to join the Immunology Department. Our team is focused on identifying new targets for the treatment of autoimmune and chronic inflammatory diseases through computational analysi...
Job Description: Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities: Equipment decommissioning and clean room updates. Valid...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global ...
Responsibilities: Review and ensure accurate and high-quality statistical programming deliverables from CRO. Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents. Cr...
Job Description: Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities include. Equipment decommissioning and clean room updates. V...
Responsibilities: The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. Regulatory Strategy Develo...
Job Description: Developing Quality Documents. Small Molecule Manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Seni...
Responsibilities: Ensure design control compliance and maintain Design History Files (DHF) for new product development. Review and approve design documentation, risk analyses (dFMEA, uFMEA, pFMEA), and verification/validation protocols. ...
Job Description: The Business System Specialist will be responsible for the creation and revision, as well as review and approval of LIMS master data within the LabVantage Laboratory Information Management System (LIMS) implemented at the...
Responsibilities: The Principal SAS Programmer will be responsible for statistical programming for the client's clinical studies. In this role, you will develop and validate SAS programs for data presentation, analyses, and provide progr...
Responsibilities: Works with the project team to author qualification deliverables such as Infrastructure/Network specifications, Qualification Protocols, Test Cases, Risk Assessments, and Summary Reports. Develop system development life...