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Bundesland Niederösterreich | Freiberuflich für ein Projekt | hays-searchresults-startdate | 418937/1
Koordination der Projekte für die technische Innovation im Rahmen von Projekten zur Technologisierung bzw. Automatisierung Sie erstellen Spezifikationen, bewerten Analysen und erarbeiten die Planung, Entwicklung und Optimierung verfahrenstechnischer Anlagen Zur Entscheidungsgrundlage und zur Überwachung der Ziele, Kosten und Qualität führen Sie Anforderungsanalysen, Auswertungen von techn. Angeboten und spezifische regulatorische Richtlinien durch (Lieferantenauswahl, Kostenkontrolle etc.)
Bundesland Wien | Freiberuflich für ein Projekt | hays-searchresults-startdate | 418818/1
Technische Teil-Projektleitung im Bereich Utilities (WFI) Strikte Einhaltung aller Qualitätsvorschriften Überwachung der Wasser-/Dampfsysteme Spezifikationserstellung, Prüfung und Freigabe Organisation und Durchführung des Monitorings Koordination der durchzuführenden vorbeugenden Instandhaltung und Reparatur bzw. Instandsetzung der kritischen Wasser- und Dampfsysteme sowie deren Support-Systeme Vertretung des Fachbereichs bei Projekt-Besprechungen Überprüfung der Dokumentation von durchgeführten internen und externen Lieferanten
Hessen | Freiberuflich für ein Projekt | hays-searchresults-startdate | 412691/1
Softwaresysteme validieren Benutzeranforderung formulieren und validieren Risk Assesstment erstellen Testpläne für Software erstellen SOP´s auf Deutsch und Englisch erstellen Kleine Server-Lösungen von max. 20 Analysegeräten Windows 10 im Laborumfeld ausrollen
Hessen | Freiberuflich für ein Projekt | hays-searchresults-startdate | 402297/1
Prozess Risikoanalyse über alle Prozesse im QM-System Identifizierung der zu validierenden Prozesse Aufbau Validierungsstrategie (Validierungsmasterplan) Aufbau Vorgabedokumente zur Prozessvalidierung (Herstellungsprozesse, Transportvalidierung) Aufbau Vorgabedokumente zur Computervalidierung und Life Cycle Management für neu und Bestandssysteme Erarbeiten der wichtigsten Validierungspläne (Prozess und CS) Durchführung Computervalidierung Erarbeitung einer Aufwandsschätzung zu den Validierungsaufwänden bei Ausbau der Organisation als Großhandel
Hessen | Freiberuflich für ein Projekt | hays-searchresults-startdate | 397325/1
Projektmanagement im Bereich von Maschinenprojekten Detailplanung anhand des Lastenheftes Inbetriebnahme der gelieferten Maschinen, insbesondere Abfüllmaschinen, Verschraubmaschinen, Pipettenverarbeitungsmaschine, Magazinierer, Höhenförderer
Bundesland Wien | Freiberuflich für ein Projekt | hays-searchresults-startdate | 397000/6
Prozessbegleitung des Baus und der Inbetriebnahme Prozessbegleitung der Planungsphasen (Basic- und Engineeringphasen)
Hessen | Freiberuflich für ein Projekt | hays-searchresults-startdate | 390683/24
Durchführung einer Ist-Analyse Erstellung eines Konzeptes für den Versorgungshof Kostenanalyse und Kostenplanerstellung Anpassung des Konzeptes an Regularien/ Anforderungen
Baden-Württemberg | Freiberuflich für ein Projekt | hays-searchresults-startdate | 389692/1
Sicherstellung der Einhaltung von internen Standartanweisungen im Rahmen der Objektüberwachung Sicherstellung und Beratung bezüglich des Arbeits-, Gesundheits-, und Brandschutzes Abnahme und Teilabnahme der Leistungen von Auftragnehmern und Lieferanten Beratung der Fachbauleitung bezüglich Bau- und Errichtungsverfahren, Terminplänen und Qualitätssicherung Erstellung und Nachführung von Mängellisten Qualitätsstichproben
Bayern | Freiberuflich für ein Projekt | hays-searchresults-startdate | 386892/1
Erstellung von Risikoanalysen für Anlagen in der Produktion (z.B. Bioreaktoren und Reinstdampfanlagen) Erstellung von SIL-Risikographen (Sicherheits-Integritätslevel) Dokumentation
Basel Stadt | Freelance/temporary employment for a project | hays-searchresults-startdate | 420869/1
Ensure the development/transfer and validation of specific and sensitive bioanalytical methods required for the drug candidates and any concomitant/ interaction therapies in a given project working closely with the internal labs and external providers (CROs Manage and direct analysis of samples and timelines from non-clinical and clinical studies for the project at CRO labs Participate actively in DMPK, clinical and study management sub-teams Review protocols and guide project teams in all aspects of bioanalytical work required for the project Review data and reports for regulatory submissions. Support filings and answer any questions coming from the regulatory agencies, as applicable Ensure full compliance with the current global and local bioanalytical regulatory guidance Ensure that the most advanced and most efficient procedures are used at the CRO Remain current and continually develop expertise in bioanalytical sciences of small molecules, including oligonucleotides analysis
Basel Stadt | Freelance/Contracting project | hays-searchresults-startdate | 420216/1
As a member of the Category Management team you are responsible for proactively identifying opportunities, engaging, and partnering with Business stakeholders and regional Procurement, and managing Category suppliers to deliver overall Category performance and saving targets. Support the definition of Category Strategy and Annual Pipeline for the Category of External Manufacturing Services on either a global or regional basis: Collate supplier, market, category and internal data and Business requirements to formulate and validate the Category Strategy and develop a pipeline of proactive initiatives based on the Category Strategy, local requirements and stakeholder planning activities. You have deep category subject matter knowledge and expertise in the supplier management approach, the specific assigned categories and work to ensure this knowledge is shared and embedded to drive performance. You provide deep expertise in supporting the realization of Procurement targets, including delivery of high value sourcing, demand management, process re-engineering, and supplier performance and innovation activities. Develop category buying guides and content to translate the Category Strategy and outcomes into clear guidance and executable content. CMO As a CMO subject matter expert and key user you are a member of the direct procurement team within the future ERP program. You will act as a liaison between Business Process Management, Direct Procurement and the ERP program workstream. The role supports the project team in analyzing business operations to assist in the design/redesign and documentation of business processes and clear definition of the business requirements regarding processes for the CMO Business Scenario (Supplier Management, Requisition to Pay, etc.). You work with operational teams, key users and other stakeholders to ensure understanding and alignment of reporting needs and E2E data governance processes. Compliance with all policies and procedures on a global and local level is an essential part of the design considerations. You implements process improvements through the introduction of appropriate workflows, tools and approval processes as well as though harmonization of processes and system design in close alignment with technical operations and finance. The design activities include translation of detailed business requirements to IT and management of changes to design specifications.
Basel Stadt | Freelance/temporary employment for a project | hays-searchresults-startdate | 419897/1
Supporting Technical Development Leaders and their CMC teams for pipeline products in clinical development until launch Ensure teams achieve and maintain a high-level of sustainable performance, by directly contributing or leading appropriate team management best practices Apply project management expertise including planning, tracking and facilitating team meetings and documenting decisions, risks and actions Provide timely information for reporting such as the annual budgeting process, appropriate governance committees, Monthly Project Reporting, and Milestone schedule activities etc. Act as catalyst and primary contact for multiple functional areas across project teams, ensuring team dynamics are collaborative
Basel region | Freelance/temporary employment for a project | hays-searchresults-startdate | 418111/1
Ensure the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by Pharma Development Provide biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs) Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders Develop and maintain effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors Manage the development and oversight of the biomarker analysis timelines, budget, risk and quality plans Provide clinical biomarker operations expertise to ensure operational feasibility and delivery Deliver the operational elements of the biomarker management plan and provide the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work Ensure study and biomarker operational adherence to ICH/ GCP and SOPs
Vienna | Freelance/Contracting project | hays-searchresults-startdate | 413855/1
Process lead for a project which involves 3 fermenters each feeding two downstream processing trains and a media preparation area with associated equipment (autoclaves, washer) End to end project from design through construction to C&Q Develop project plans and take care of interface management during the commissioning phase Prepare specifications and compare suppliers and sub-contractors, vendors on a technical basis Interface with the design team, equipment vendors, construction team and C&Q experts
Basel Stadt | Freelance/temporary employment for a project | hays-searchresults-startdate | 409058/11
As Scientific Communications Director you identify the audience, define the channels and the content of all Scientific Communication activities for the assigned molecule/franchise Responsible for internal assessment of needs for: format/material/external engagements for internal training; includes setting up and maintaining the materials for internal and external knowledge platforms Responsible for orchestrating the Scientific Communications strategy and dissemination of data for the assigned molecule/franchise disease area through an integrated scientific story and communications strategy; Scientific Communications Strategy development as part of the global brand and medical strategy, publications strategy (incl. planning and management), medical education (internal & external) and management of scientific communications focused activities Work with appropriate stakeholders to drive the development of the Publication strategy Act as the strategic partner to US Medical Affairs responsible for the planning of the US focused Publication strategy and implementation Responsible for the strategy, planning and execution of the Medical Education activities and ensuring that these are based on insights and educational needs Plan and drive the publication activities, e.g. submissions to peer reviewed journals scientific and medical education activities at congresses Responsible for the development of patient focused educational materials Drive, coordinate and communicate activities related to pre-congress medical education materials, including e-learnings and others Responsible for assessment, maintain oversight of the key affiliate publications Provide input and/or lead advisory board plans for assigned molecules/franchise Responsible for budget planning and tracking of the respective areas/activities Engage in regular prioritization, delegation and alignment discussions with vendors Monitor vendor performance based on cross-functional team assessments, aligned with procurement
Marburg | Freelance/Contracting project | hays-searchresults-startdate | 407870/1
Erect a new production building as a green field project Cover all engineering disciplines within an ECPM approach with external engineering office (EO) Ensure implementation of the GSK standards and requirements with a team of GSK engineers as counterpart to EO engineers Check engineering documents on design aspects Monitor process of Clean Utilities engineering, review, rework and approval of documents Key project responsible for Clean Utilities Alignment with Global Engineering standards
Basel Stadt | Freelance/temporary employment for a project | hays-searchresults-startdate | 408485/11
Identify evidence needs and recommend data solutions: ask the right scientific questions, understand the evidence needs for research and development, regulatory and market access, and ideate and make recommendations on fit-for-purpose data and analytics solutions Drive into data: develop a comprehensive and deep understanding of the data we work with using analytical tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately Be an expert in applying methods: stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches Produce high quality analyses: apply rigor in study design and analytical methods; plan for data processing; design a fit-for-purpose analysis plan, assess effective ways of presenting and delivering the results to maximize impact and interpretability; implement and/or oversee the study, including its reporting; ensure compliance with applicable pharma industry regulations and standards Interpret and share results: communicate findings to internal stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities; publish results; participate in external
Basel Stadt | Freelance/temporary employment for a project | hays-searchresults-startdate | 401736/1
Collaborate with clinical development teams to refine remote patient monitoring solutions and workflows for use in clinical trials (especially in Multiple Sclerosis drug development) Develop remote patient monitoring aspects of the clinical trial design, protocols and informed consents Specify study-specific workflows and requirements for software development teams Ensure the software/remote patient monitoring solutions meet the needs for clinical deployment Conduct qualitative studies, including physician and patient focus groups, to establish clinical meaningfulness of the collected data and optimize the usability of software/remote patient monitoring solutions Manage the deployment of the remote patient monitoring solutions into clinical studies Deliver trainings on the remote patient monitoring approach to physicians and study coordinators Manage the support of the remote patient monitoring solutions in studies, including by being a point of contact for physicians and study coordinators Prepare and deliver management presentations on the digital biomarker data analysis results Manage internal and external stakeholders
Lower Austria | Freelance/Contracting project | hays-searchresults-startdate | 392752/6
End to end project from design through construction to C&Q Interface with the design team, equipment vendors, construction team and C&Q experts Develop project plans and strategies and successfully execute them according to established schedule, cost and performance standards (biotech)

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