Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards. Mentor and coach colleagues as required including the delivery of training materials as required. Qualifications Bachelor's Degree Related field OR 5-year relevant sponsor or clinical research organization clinical site contracting experienceGood negotiating and communication skills with ability to challenge.Strong legal, financial and/or technical writing skills.Strong understanding of regulated clinical trial environment and knowledge of drug development process.Good understanding of clinical trial contract management.Fluent in English and German language IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
About us Your Contribution Possess knowledge and capabilities to execute Maintenance/Facilities Technician (all levels) roles and responsibilitiesMonitor daily work orders and employee activitiesCoordinate with various department stakeholders on Maintenance actionsHelp minimize machine downtimeLead, coach and train Maintenance TechniciansProcure parts, materials and resources to increase machine uptime; impart expertise and techniques to others within the departmentEstablish shift schedules to meet business needs; manage employee schedulesActively lead and participate in projects/events to drive improvementsFill in for the Maintenance Manager, as neededHelp with achieving department deliverables and initiatives Participate in the interviewing/hiring processHost meetings accordinglyEnsure clean and safe workspacesMaintain attendance within the payroll systemFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, required / Vocational school degree, preferredMinimum (3) years of maintenance/facilities experience in leading and directing the work of others in a fast-paced manufacturing settingStrong mechanical aptitudeUnderstanding of ISO and cGMPAbility to foster and follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachService orientedRobust communication skills and openness to learn/developWork a fixes 8-hour shift schedule Monday to Friday, but some weekend/night work, as neededUp to 5% travel, if needed to satisfy business demand Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
About us Your Contribution Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectivesAssist in developing department budget and investment plan(s) according to strategic goalsCultivate employee talent through training and coaching measures, while also conducting employee performance reviewsSupport the development and updating of Quality Assurance programs, policies, processes, procedures and controlsReview, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepanciesManage the review of batch records and avoid impacting shipment datesManage Department Training Coordinator activities and projectsManage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documentsLead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirementsMeasure and analyze Quality System trendsOversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)Maintain the Archive Room and document retention requirementsWrite and revise Standard Operating Procedures (SOPs) and provide training, as requiredManage the CAPA and Change-Control process to include, issuing, reviewing and approving stepsSupport all customer or registrar quality related audits and/or evaluationsUtilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business UnitManage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findingsHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceAssure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines Your Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language