Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Organisatorische & administrative Unterstützung des Teams und anderen Stakeholdern
  • Betreuung von ad hoc Projekten
  • Verwaltung des Promotionsmaterials sowie Verantwortung für die Verteilung dessen nach unseren vordefinierten Standardprozessen
  • Administration von Genehmigungs- und Compliance Prozessen betreffend des Promotionsmaterials
  • Durchführung von Bestellungen und Rechnungsprüfung
  • Unterstützung des Teams beim Vertragsmanagement und bei der Aufrechterhaltung der Kontakte zu externen Agenturen und medizinischen Fachkräften/Organisationen
  • Koordination abteilungsübergreifender Themen mit der Einkaufs-, Compliance- und Rechtsabteilung
  • Unterstützung in der Kundenbetreuung

IHRE FÄHIGKEITEN

  • Erfolgreich abgeschlossene kaufmännische Ausbildung (BSc) mit Schwerpunkt Kommunikation/Marketing von Vorteil
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Sehr gute MS Office Kenntnisse
  • Eigenständiger, genauer sowie lösungsorientierter Arbeitsstil mit Innovationsgedanken
  • Ausgezeichnete soziale Kompetenz und Kommunikationsfähigkeit
  • Flexible Teamplayer/in
  • Positive und verlässliche Persönlichkeit
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein Mindestgehalt von EUR 39.200,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Manage stability program for market products
  • Contribute to and review stability protocols
  • Establish trending sheets/rules and statistical analysis for stability and release data
  • Keep overview on assay performance trending sheets
  • Maintain documentation for stability samples and trending
  • Serve as QC point of contact for installation of stability and trending software, including drafting of design and user requirements, oversee and support execution of software validation and implementation
  • Responsible for placing samples on stability, pulling samples, ensuring completion of testing, recording tracking and trending of test results
  • Initiating and completing deviations, CAPAs, OOS, OOC, laboratory investigations, and Change Controls as needed
  • Perform testing as needed
  • Strong knowledge of cGMP, Quality systems, and ICH / regulatory guidance

YOUR QUALIFICATIONS

  • Bachelor, Master Degree or equivalent in a relevant field (e.g. Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology)
  • Experience with setting up and coordinating stability studies
  • Experience with trending of results
  • Experience with statistical analysis of data
  • Knowledge of relevant guidelines
  • Experience with deviations, changes and preparation of reports
  • Background knowledge on assays performed for stability studies
  • Team work and excellent organizational skills
  • Fluent in English (oral and written), fluent in German

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 40.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Supervise development and validation of immunological assays
  • Supervision of GCLP-compliant immunogenicity testing for clinical trials (scientific, technical and organizational aspects)
  • Assay planning, analysis, review, as well as assay maintenance and trouble shooting
  • Writing technical protocols/reports (Assay development and validation, Analytical Plans and Reports) and other GxP documentation
  • Evaluation and presentation of data
  • Provide expertise and support to other functions within the organization
  • Establish, maintain and supervise collaborations with external partners

YOUR QUALIFICATIONS

  • PhD in the fields of Immunology, Virology and/or Microbiology
  • Work experience in the life science industry or experience with clinical studies is a plus
  • Hands-on experience on immunological/biological assays/analytical methods (e.g. ELISA, cell based assays, RT-qPCR)
  • Knowledge in development of assays
  • Experience in an GxP environment is a plus
  • Excellent analytical/problem solving skills
  • Strong organizational and communication skills
  • Fluent English
  • Good presentation techniques
  • Able and used to work under time pressure on multiple projects in a changing environment

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

 

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Coordination of Analytical Transfer to external Partner (including material shipment, trainings, summary of data etc.)
  • Interface between internal SMEs and external Partner, ensuring efficient communication and information dissemination with the department, cross-department and with external partner
  • Ensure compliance with internal and external procedures (e.g. international GMP requirements), legal and regulatory requirements
  • Ensure timely completion of milestones according to project plans by e.g. pro-active follow up and timely delivery of action items.
  • Be familiar with the analytical methods to be transferred
  • Accurately summarize and present results of studies internally and externally
  • Become an integral part of highly interactive team working on multiple projects

YOUR QUALIFICATIONS

  • University degree in relevant scientific field
  • Work experience in the life science environment
  • Background in analytical and immunological/microbiological methods applicable to vaccines
  • Good understanding of current Good Manufacturing and Good Laboratory Practices (GMP, GLP), ICH guidance for quality practices and well as other pharmaceutical regulatory guidelines, especially related to the biotechnology industry and analytical transfers
  • Ability to work according to challenging timelines
  • Team work, excellent organizational skills
  • Advanced presentation skills for various stakeholders and audiences
  • Computer software (MS Office ..) and knowledge in statistical analyses
  • Fluent in English (oral and written), fluent in German

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 48.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Commercial Coordinator (f/m/d)

100%, indefinite duration, as soon as possible

YOUR RESPONSIBILITIES

  • Provide administrative and organizational support to the Commercial Team and other identified stakeholders
  • Manage ad hoc projects whenever requested
  • Manage stock of promotional material and take responsibility for the distribution of material following our standard operating procedures
  • Administering promotional approvals and compliance processes for associated materials
  • Create purchase orders and monitoring invoices
  • Support team in handling contracts and liaise with external agencies and health care professionals and/or organizations
  • Coordinate cross-functional team efforts with procurement, compliance and legal
  • Assist in customer interactions as needed

YOUR QUALIFICATIONS

  • Bachelor’s degree in economics (marketing / communication would be an asset) with good experience in a supportive function in a commercial organization, preferably within Life Sciences
  • Fluent English and German with strong verbal and written skills
  • Proficiency with standard Windows and Office programs
  • Must be able to work well independently under the general guidance of the manager
  • Organized with strong systematic approach to prioritization
  • Solution-focused working style and ability to develop innovative ideas
  • Excellent interpersonal skills and ability to work flexibly in a small and focused team
  • Positive and accountable personality

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 39.200,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva est une société spécialisée dans le développement et la commercialisation de vaccins prophylactiques contre des maladies infectieuses générant d’importants besoins médicaux. Le Groupe a mis à profit son expertise et ses infrastructures pour commercialiser avec succès deux vaccins et pour faire rapidement progresser un large éventail de candidats vaccins en développement clinique, et notamment ses candidats vaccins contre la maladie de Lyme, le virus du chikungunya et la COVID-19.

YOUR RESPONSIBILITIES

  • Proactive support of all aspects of one or more Phase 1-4 clinical studies (for chikungunya vaccine development)
  • Support in the implementation of clinical studies from start-up to study completion
  • Contribution to the development of study relevant documents in the project development cycle
  • Support in CRO/vendor selection process and CRO/vendor oversight
  • Monitoring and execution of all study activities in compliance with ICH-GCP and FDA/EMA/MHRA requirements
  • Cross-functional collaboration with internal and external stakeholders (e.g. CROs)
  • Support in budget planning and financial tracking

YOUR QUALIFICATIONS

  • Academic education, Master or PhD degree (Life Science)
  • At least 1 year of relevant experience as a CRA in the pharma/life science industry
  • Project management experience is an advantage
  • Ideally experience in the field of vaccine development as well as supervision of CROs and CRAs
  • Team oriented, stress resistant personality
  • Strong communication and organizational skills
  • Ability to prioritize and maintain oversight
  • Very good command of English (spoken and written)

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 50.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

100%, as soon as possible, limited for 3 years

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Coordinate and participate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental products
  • Operate electronic submission tools (eCTD manager, validation tools) and electronic Data Management Systems (eDMS) used at Valneva Austria GmbH
  • Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
  • Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives
  • Provide regulatory feedback in project teams
  • Participate in contacting competent authorities for respective projects/products and interact with internal departments
  • General regulatory and maintenance tasks

YOUR QUALIFICATIONS

  • University degree in science and/or regulatory affairs
  • 4 – 5 years’ experience in Pharmaceutical industry preferably with vaccines
  • 1-2 years experience in Regulatory affairs
  • Experience in Regulatory Life Cycle Management and eCTD is an advantage, although not required
  • Excellent English and German skills
  • Proficiency with standard Windows and Office programs
  • Experience with electronic document management systems and IT knowledge
  • Good social skills and ability to work in teams

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung, Revision und Verifizierung analytischer Daten
  • Erstellung, Revision und Überprüfung der GMP-relevanten Dokumenten (zB Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Zumindest 4 Jahre Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein Mindestgehalt von EUR 40.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva est une société spécialisée dans le développement et la commercialisation de vaccins prophylactiques contre des maladies infectieuses générant d’importants besoins médicaux. Le Groupe a mis à profit son expertise et ses infrastructures pour commercialiser avec succès deux vaccins et pour faire rapidement progresser un large éventail de candidats vaccins en développement clinique, et notamment ses candidats vaccins contre la maladie de Lyme, le virus du chikungunya et la COVID-19.

YOUR RESPONSIBILITIES

  • Management of clinical study documents, including overseeing TMF-activities and creating, maintaining and filing sponsor study files in a timely manner
  • Track study activities, e.g., CRA monitoring visits, essential documents, and study site correspondence; review monitoring reports
  • Track regulatory documentation as required by national regulatory authorities
  • Serve as a liaison with purchasing department to ensure adequate supplies are ordered
  • Assist in management of shipments of investigational materials, site supplies or clinical samples and coordinate with Clinical Operations Manager, internal stakeholders and external vendors
  • Assist in study site/vendor payment procedures
  • Conduct Clinical Operations tasks in accordance with applicable Quality Systems
  • Assist in management of internal and external risk assessments and any corrective/preventative actions
  • Support Clinical Operations team with study-specific tasks as needed

YOUR QUALIFICATION

  • At least 3 years of relevant experience as a CTA in the pharma/life science industry, CRA experience is of advantage
  • Team oriented, stress resistant personality
  • Strong communication and organizational skills
  • Ability to prioritize and maintain oversight
  • Very good command of English (spoken and written)

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 42.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

100%, as soon as possible, limited for 18 months

Vos responsabilités

  • Proactive support of all aspects of one or more phase 1-4 clinical studies (for Covid-19 vaccine or for Lyme vaccine development)
  • Support in the implementation of clinical studies from start-up to study completion
  • Contribution to the development of study relevant documents in the project development cycle
  • Monitoring and execution of all study activities in compliance with ICH-GCP and FDA/EMA/MHRA requirements
  • Cross-functional collaboration with internal and external stakeholders (e.g. CROs)
  • Support in budget planning and financial tracking

Your qualifications

  • Academic education, Master or PhD degree (Life Science)
  • At least 1 year of relevant experience as a CRA in the pharma/life science industry
  • Project management experience is an advantage
  • Ideally experience in the field of vaccine development as well as supervision of CROs and CRAs
  • Team oriented, stress resistant personality
  • Strong communication and organizational skills
  • Ability to prioritize and maintain oversight
  • Very good command of English (spoken and written)

Our offer

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 50.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.