medac GmbH
22880 Wedel - Deutschland
Arzt/Ärztin
Arbeit
Vollzeit
ab 16.06.2026
Beschreibung
About medac
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 (all genders).
About the Role
You lead and evaluate medac’s Managed Access Programs (MAP) and... weiter lesen
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 (all genders).
About the Role
You lead and evaluate medac’s Managed Access Programs (MAP) and... weiter lesen
About medac
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 (all genders).
About the Role
You lead and evaluate medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective, ensuring robust benefit-risk assessments and patient-focused decision-making. You are a hands-on Medical Expert responsible for executing clinical-scientific activities across the product lifecycle, focussed on the development of high-quality regulatory documentation (CTD) and support of global submissions and lifecycle management. You act as a cross-functional clinical partner, translating clinical data into consistent scientific messaging and supporting decision-making across clinical science. You bring experience in innovative therapies, including cell therapies, within evolving clinical and regulatory environments.
Lead and evaluate medac’s Managed Access Programms (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective
Ensure robust benefit-risk justification, regulatory alignment and high-quality documentation
Interface with regulatory, legal, pharmacovigilance and commercial stakeholders on access strategies
Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other lifecycle documents
Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs
Contribute to regulatory strategy documents, briefing packages and support global regulatory interactions, including scientific advice procedures and health authority meetings
Medical Doctor required
Deep understanding of global drug development and regulatory frameworks
Strong background in Phase I-III trials, medical monitoring and clinical practice
Demonstrated experience in cell therapies / ATMPs (highly preferred), Managed Access Programs (MAP) / Named Patient Use (NPU) and regulatory submission (CTD authoring, Module 2)
Therapeutic expertise in oncology, hematology, rheumatology or immunology
Exceptional medical writing and storytelling capability
Strong analytical thinking and benefit-risk assessment skills
Ability to translate complex science into clear strategic recommendations
Language: fluent English, German preferred
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 programs 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
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 (all genders).
About the Role
You lead and evaluate medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective, ensuring robust benefit-risk assessments and patient-focused decision-making. You are a hands-on Medical Expert responsible for executing clinical-scientific activities across the product lifecycle, focussed on the development of high-quality regulatory documentation (CTD) and support of global submissions and lifecycle management. You act as a cross-functional clinical partner, translating clinical data into consistent scientific messaging and supporting decision-making across clinical science. You bring experience in innovative therapies, including cell therapies, within evolving clinical and regulatory environments.
Lead and evaluate medac’s Managed Access Programms (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective
Ensure robust benefit-risk justification, regulatory alignment and high-quality documentation
Interface with regulatory, legal, pharmacovigilance and commercial stakeholders on access strategies
Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other lifecycle documents
Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs
Contribute to regulatory strategy documents, briefing packages and support global regulatory interactions, including scientific advice procedures and health authority meetings
Medical Doctor required
Deep understanding of global drug development and regulatory frameworks
Strong background in Phase I-III trials, medical monitoring and clinical practice
Demonstrated experience in cell therapies / ATMPs (highly preferred), Managed Access Programs (MAP) / Named Patient Use (NPU) and regulatory submission (CTD authoring, Module 2)
Therapeutic expertise in oncology, hematology, rheumatology or immunology
Exceptional medical writing and storytelling capability
Strong analytical thinking and benefit-risk assessment skills
Ability to translate complex science into clear strategic recommendations
Language: fluent English, German preferred
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 programs 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
Ref-Nr.: 11530867
Aktualisiert:
19.06.2026
Quelle: Bundesagentur für Arbeit
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
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