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Jobs at SmartStep Consulting GmbH (Now Hiring) — 2 open

SmartStep Consulting GmbH logoSmartStep Consulting GmbH

Pharmazeut, Biologe, Humanbiologe oder Mediziner (m/w/d)

Hamburg, Germany · On-site

Entry level

Unsere Vision Ihre Aufgaben Unterstützung unseres Projektteams bei der Erstellung und Qualitätssicherung von Dossiers zur frühen Nutzenbewertung von Arzneimitteln (nach § 35a SGB V) und Medizinprodukten im Rahmen des Arz…

Skills: Clinical Study Analysis, AMNOG Process, Evidence-Based Analysis, Dossier Creation, Quality Assurance

SmartStep Consulting GmbH logoSmartStep Consulting GmbH

Gesundheitsökonom oder Wirtschaftswissenschaftler (m/w/d)

Hamburg, Germany · On-site

Entry level

Unsere Vision Ihre Aufgaben Unterstützung unseres Projektteams bei der Entwicklung von Market-Access- und Pricing-Strategien für innovative Arzneimittel im deutschen GesundheitsmarktVorbereitung und Begleitung von Preisv…

Skills: Market Access, Pricing Strategies, Health Economics, Data Analysis, AMNOG Process

SmartStep Consulting GmbH logo

Pharmazeut, Biologe, Humanbiologe oder Mediziner (m/w/d)

SmartStep Consulting GmbH

Hamburg, Germany • On-site

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Entry level

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  • Full-time, Part-time
  • postgraduate degree
  • Flexible Working Models, Individual Development Opportunities, Collaborative Team Environment
  • Posted 11d ago
  • ~40 hrs/week
  • German

Responsibilities

Support the project team in creating and ensuring the quality of dossiers for early benefit assessments of pharmaceuticals and medical devices. Interpret clinical studies and scientific evidence using IQWiG and G-BA methodologies while utilizing AI tools for optimization.

Requirements

Requires a Master's degree in Pharmacy, Biology, Medicine, or a related field with initial experience in evidence-based clinical study analysis. Candidates must possess strong analytical skills, proficiency in German and English, and an openness to using AI technologies.

Full job description

Unsere Vision

Ihre Aufgaben

  • Unterstützung unseres Projektteams bei der Erstellung und Qualitätssicherung von Dossiers zur frühen Nutzenbewertung von Arzneimitteln (nach § 35a SGB V) und Medizinprodukten im Rahmen des Arzneimittelmarkt-Neuordnungsgesetzes (AMNOG)
  • Interpretation und strukturierte Aufbereitung klinischer Studien und wissenschaftlicher Evidenz
  • Anwendung der Methoden des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) sowie der Anforderungen des Gemeinsamen Bundesausschusses (G-BA)
  • Nutzung und Steuerung KI-gestützter Tools zur effizienten Erstellung und Optimierung von Dossierinhalten

Ihr Profil

  • Masterabschluss in Pharmazie, Biologie, Biochemie, Molekularbiologie, Medizin oder vergleichbare Qualifikation
  • Erste Erfahrung in der evidenzbasierten Analyse klinischer Studien und idealerweise im AMNOG-Prozess
  • Strukturierte, analytische und sorgfältige Arbeitsweise sowie hohe Qualitätsorientierung
  • Ein hohes Maß an Eigeninitiative, Einsatzbereitschaft und Problemlösungsfähigkeit
  • Offenheit für den Einsatz neuer Technologien, insbesondere KI-gestützter Anwendungen
  • Verhandlungssichere Deutsch- und Englischkenntnisse in Wort und Schrift sowie sicherer Umgang mit MS Office

Warum wir?

  • Mitarbeit an hochrelevanten Fragestellungen im Bereich Market Access und Nutzenbewertung von neuen Arzneimitteln
  • Einsatz innovativer Technologien (inkl. KI) in einem zukunftsorientierten Arbeitsumfeld
  • Dynamisches, kollegiales Team mit flachen Hierarchien
  • Flexible Arbeitsmodelle und individuelle Entwicklungsmöglichkeiten

About us

SmartStep Consulting bietet individuelle, hochspezialisierte Dienstleistungen für die Pharma- und Medizintechnikbranche an, um Patienten den schnellen Zugang zu neuen und besseren Behandlungsmöglichkeiten zu ermöglichen. Als Teil der G&L Group strebt SmartStep an, seine Dienstleistungen auszubauen und internationale Chancen zu nutzen, die sich aus den neuen EU-HTA Verfahren ergeben.

Related keywords

AMNOGIQWiGG-BAMarket AccessBenefit AssessmentClinical StudiesPharmaceuticalsMedical DevicesAI ToolsEvidence-Based MedicineDossier ManagementHealthcare Consulting

About SmartStep Consulting GmbH

LinkedInVisit site

Every patient shall have a fast access to the best-possible therapy at a fair price.

Industry
Business Consulting and Services
Company size
51-200 employees
Founded
2010
Headquarters
Hamburg, Hamburg
LinkedIn followers
1,306

With over 15 years of proven expertise in Market Access, SmartStep provides highly specialized and individualized consulting for the pharmaceutical, vaccine, and biotech industry. We support our clients in achieving, defending, and maintaining fast, efficient, and evidence-based Market Access for their products. As one of the early pioneers, we introduced Artificial Intelligence into Medical Writing and Dossier Development – applying advanced technologies to increase efficiency, quality, and innovation at a time when the industry was only beginning to explore such approaches. This forward-thinking mindset, combined with our deep scientific and strategic knowledge, enables us to deliver tailored solutions that anticipate challenges and maximize value for patients, healthcare systems, and manufacturers alike. SmartStep stand for excellence, agility, and partnership – ensuring that every product has the best possible path to successful and sustainable Market Access. Building on this strong foundation, we are pursuing continuous growth and internationalization – expanding our network, capabilities, and partnerships to serve clients across Europe and beyond. Because for us, Market Access is never just about products – it is about making sure every patient gets timely access to the right therapy at the right value. IMPRINT: https://www.smartstep-consulting.de/en/legal-notice/ PRIVACY POLICY: https://www.smartstep-consulting.de/en/data-protection/

Offices: Alter Teichweg 25a, Hamburg, Hamburg 22081, DE

Market AccessStatisticsHealthcare Strategy ConsultingBiotech Contract ManagementSubmissionsDossierPatient Reported Outcomes (PRO)Medical WritingReal World Evidence (RWE)
View all jobs at SmartStep Consulting GmbH

About SmartStep Consulting GmbH

LinkedInVisit site

Every patient shall have a fast access to the best-possible therapy at a fair price.

Industry
Business Consulting and Services
Company size
51-200 employees
Founded
2010
Headquarters
Hamburg, Hamburg
LinkedIn followers
1,306

With over 15 years of proven expertise in Market Access, SmartStep provides highly specialized and individualized consulting for the pharmaceutical, vaccine, and biotech industry. We support our clients in achieving, defending, and maintaining fast, efficient, and evidence-based Market Access for their products. As one of the early pioneers, we introduced Artificial Intelligence into Medical Writing and Dossier Development – applying advanced technologies to increase efficiency, quality, and innovation at a time when the industry was only beginning to explore such approaches. This forward-thinking mindset, combined with our deep scientific and strategic knowledge, enables us to deliver tailored solutions that anticipate challenges and maximize value for patients, healthcare systems, and manufacturers alike. SmartStep stand for excellence, agility, and partnership – ensuring that every product has the best possible path to successful and sustainable Market Access. Building on this strong foundation, we are pursuing continuous growth and internationalization – expanding our network, capabilities, and partnerships to serve clients across Europe and beyond. Because for us, Market Access is never just about products – it is about making sure every patient gets timely access to the right therapy at the right value. IMPRINT: https://www.smartstep-consulting.de/en/legal-notice/ PRIVACY POLICY: https://www.smartstep-consulting.de/en/data-protection/

Offices: Alter Teichweg 25a, Hamburg, Hamburg 22081, DE

Market AccessStatisticsHealthcare Strategy ConsultingBiotech Contract ManagementSubmissionsDossierPatient Reported Outcomes (PRO)Medical WritingReal World Evidence (RWE)
View all jobs at SmartStep Consulting GmbH

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