Job Archives
Location: Wilmington, NC Interview: Phone/Skype Start date: 10/01 Category: Full Time Roles & Responsibilities: Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available. Manage and maintain Global safety mailbox. May participate in the case narrative generation, review and refinement process depending upon level…
Interview: Phone/Skype Start date: 10/01 Category : Full Time Roles & Responsibilities: Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP)…
Location: Rensselaer, NY Interview: Phone/Skype Start date: 10/01 Category : Full Time Qualify equipment based on cGMP (Good Manufacturing Practices) standards. Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility. Review the Installation & Operational Qualification procedure of the newly installed Air Handling Unit (AHU)…
Location: Fremont, CA Interview: Phone/Skype Start date: 10/01 Category : Full Time Involve in documentation of different stages of validation life cycle in compliance with 21 CFR Part 11. Responsible in analyzing business requirements, development of validation plans (VP),Validation Protocols (Installation Qualification, Operational Qualification and Performance Qualification), Requirement Traceability Matrix (RTM) and Summary Reports (validation and Test…
Location: McPherson, KS Interview: Phone/Skype Start date: 10/01 Category : Full Time Perform Chemical assessment to determine the storage conditions of the finished, semi-finished products, work in progress chemical, active pharmaceutical ingredients (API’s), other chemicals and manufacturing components (eg: vials, ampoules) of pharma products. Develop and Execute Validation life cycle deliverables which include Validation plans, requirement…
Location: Tarrytown, NY Interview: Phone/Skype Start date: 10/01 Category : Full Time Perform, record, troubleshoot and analyze temperature mapping of manufacturing equipment using Kaye Validator 2000, Advanced systems (AVS), Data loggers and data traces using Val-suite Pro and track sense Pro. Assist in project management by updating equipment information, calibration schedule, preventive maintenance schedule, re-qualification…
Location: McPherson, KSInterview: Phone/Skype Start date: 10/01 Category : Full Time Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility. Ensure that the development and maintenance process are adequate in order, for the system to meet its objective. Responsible for document preparation and execution…
Start: 9/25 Interview: Phone, Skype Length: 1 year plus Type: Contract Prerequisites: Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 5 years of regulatory writing and submission experience Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books Experience in oncology, hematology, and/or inflammation and…
The Medical Affairs Manager, Hematology, is a member of the Oncology brand Core Medical Teams, and supports the development and execution of the Brand Medical Plans. Responsibilities include