Medical Expert – Clinical Science (m/f/d)

Medac Group; Hamburg; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Flexible Arbeitszeiten

Telearbeit anteilig möglich

30 Urlaubstage pro Jahr

Kantine

Betriebliche Altersvorsorge

Medac Academy – Weiterbildung

Job summary

medac sucht eine/n Medical Expert – Clinical Science (m/w/d) am Standort Wedel bei Hamburg. Sie arbeiten an klinisch-wissenschaftlichen und regulatorischen Aufgaben über den Produktlebenszyklus hinweg und unterstützen globale Einreichungen sowie Lifecycle-Management.

Sie übersetzen klinische und wissenschaftliche Daten in klare medizinische und regulatorische Schlussfolgerungen und arbeiten eng mit Clinical Development, Regulatory Affairs und Pharmacovigilance zusammen.

Qualifications

• Medizindoktor mit relevanter pharmazeutischer Erfahrung
• Ausgeprägte schriftliche und mündliche Kommunikationsfähigkeiten
• Wert gelegt wird auf wissenschaftliche Präzision und Regulatory-Standards

Responsibilities

• Verfassen, Prüfen und Leiten klinisch-wissenschaftliche und regulatorische Dokumente (CTD)
• Daten in medizinisch-wachsender regulatorischer Position interpretieren
• Sicherstellen von Konsistenz, Qualität und Compliance in Submission- und Lifecycle-Dokumenten
• Unterstützung von Benefit-Risk-Bewertungen und medizinisch-wissenschaftlichen Einschätzungen
• Beurteilung von MAP- und NPU-Anfragen mit evidenzbasierter Empfehlung
• Medizinische Monitoring-Unterstützung für klinische Studien
• Beratung klinischer Entwicklungs­teams mit medizinischer Expertise
• Wissenschaftliche Inputs in Studiendesign und Entwicklungspläne liefern
• Teilnahme an bildungspolitischen Bewertungen für neue Produktoptionen

Skills

Fluent English

Wissenschaftliches Schreiben

Kommunikation

Education

Medical Doctor

Job description

We are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry. Look into this job opportunity and become part of an exceptional workforce.

At our location in Wedel near Hamburg, we are looking for a Medical Expert – Clinical Science (m/f/d).

About the role

Hands-on medical expert responsible for clinical-scientific and regulatory activities across the product lifecycle, with a strong focus on the preparation of high-quality regulatory documentation, scientific data interpretation, support of global submissions and lifecycle management activities. Acts as a cross-functional scientific partner, translating clinical and scientific data into clear medical and regulatory conclusions. Contributes to benefit-risk assessments, evidence-based decision-making and health authority interactions in close collaboration with Clinical Development, Regulatory Affairs and Pharmacovigilance. Supports clinical trials through medical monitoring activities and serves as a medical advisor to clinical development teams. Provides medical-scientific oversight of Managed Access Programs (MAP) and Named Patient Use (NPU) requests, including medical assessment of individual requests and benefit-risk evaluations to support approval decisions. Participates in scientific evaluations and due diligence activities for new product opportunities, including assessment of clinical data, unmet medical need and benefit-risk profiles.

• Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overviews and Clinical Summaries, Clinical Expert Statements, Risk Management Plans (RMPs), SmPCs, CCDS, PILs, PSURs / DSURs and other lifecycle management documents
• Interpret and integrate clinical and scientific data into robust medical-scientific and regulatory positions
• Ensure medical and scientific consistency, quality and compliance across submission and lifecycle documentation
• Support benefit-risk evaluations and medical-scientific assessments across the product portfolio
• Evaluate Managed Access Program (MAP) and Named Patient Use (NPU) requests and provide evidence-based medical recommendations to support approval decisions
• Provide medical monitoring support for assigned clinical trials
• Serve as a medical advisor to clinical development teams and contribute medical expertise to clinical development documents and activities
• Support clinical development programmes through scientific input into study design, development plans and evidence-generation activities
• Participate in scientific evaluations and due diligence activities for new product opportunities, including assessment of clinical data, unmet medical need and benefit-risk profiles

We are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry. Look into this job opportunity and become part of an exceptional workforce.

At our location in Wedel near Hamburg, we are looking for a Medical Expert – Clinical Science (m/f/d).

About the role

Hands-on medical expert responsible for clinical-scientific and regulatory activities across the product lifecycle, with a strong focus on the preparation of high-quality regulatory documentation, scientific data interpretation, support of global submissions and lifecycle management activities. Acts as a cross-functional scientific partner, translating clinical and scientific data into clear medical and regulatory conclusions. Contributes to benefit-risk assessments, evidence-based decision-making and health authority interactions in close collaboration with Clinical Development, Regulatory Affairs and Pharmacovigilance. Supports clinical trials through medical monitoring activities and serves as a medical advisor to clinical development teams. Provides medical-scientific oversight of Managed Access Programs (MAP) and Named Patient Use (NPU) requests, including medical assessment of individual requests and benefit-risk evaluations to support approval decisions. Participates in scientific evaluations and due diligence activities for new product opportunities, including assessment of clinical data, unmet medical need and benefit-risk profiles.

Aufgaben

• Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overviews and Clinical Summaries, Clinical Expert Statements, Risk Management Plans (RMPs), SmPCs, CCDS, PILs, PSURs / DSURs and other lifecycle management documents
• Interpret and integrate clinical and scientific data into robust medical-scientific and regulatory positions
• Ensure medical and scientific consistency, quality and compliance across submission and lifecycle documentation
• Support benefit-risk evaluations and medical-scientific assessments across the product portfolio
• Evaluate Managed Access Program (MAP) and Named Patient Use (NPU) requests and provide evidence-based medical recommendations to support approval decisions
• Provide medical monitoring support for assigned clinical trials
• Serve as a medical advisor to clinical development teams and contribute medical expertise to clinical development documents and activities
• Support clinical development programmes through scientific input into study design, development plans and evidence-generation activities
• Participate in scientific evaluations and due diligence activities for new product opportunities, including assessment of clinical data, unmet medical need and benefit-risk profiles

Profil

• Medical Doctor
• Several years of experience in clinical development, clinical science, medical affairs, medical monitoring, regulatory affairs or a comparable role within the pharmaceutical industry
• Strong scientific writing and communication skills, including experience in authoring CTD Module 2.5 and 2.7 documents
• Know-how in benefit-risk assessments and regulatory interactions
• Solid understanding of global drug development, clinical research, regulatory requirements and lifecycle management
• Experience as a medical monitor and/or scientific supporter of clinical trials desirable
• Practice in the scientific evaluation of licensing opportunities and/or due diligence activities preferred
• Ability to provide medical guidance and translate complex scientific information into clear and actionable recommendations
• Proactive, collaborative and hands-on working style with strong cross-functional communication skills
• Fluent English; German advantageous

Wir bieten

Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:

• Your work-life balance is important to us. We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria
• Attractive salaries and success-based bonuses for all medac employees
• Individual training opportunities: our medac academy offers a wide range of programmes, including leadership training, coaching essentials and language classes
• A funded pension scheme and other social benefits
• We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling
• We promote sports and activities to improve our employees' health

Important note

Please be advised that a valid work permit for Germany is required for non‑EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.

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