Senior Medical Expert (m/w/d)

SThree; Hamburg; Vor Ort; EUR 100.000 - 140.000; Vollzeit

Zusammenfassung

SThree, Hamburg, seeks an MD-regulatory leader to shape access strategies for complex therapies. You will prepare CTD modules, write expert statements and risk documentation, while ensuring compliance across global programs including ATMPs.

Collaborating with RA, Legal, Pharmacovigilance and Commercial teams, you will develop benefit-risk arguments and guide strategic regulatory decisions for trials across phases I–III.

Qualifikationen

• MD required with strong regulatory experience and scientific writing skills.
• Solid knowledge of global drug development and regulatory requirements.
• Experience across clinical trial phases I–III, including monitoring.
• ATMP or cell therapy familiarity is highly desirable.
• Therapeutic knowledge in oncology, hematology, immunology or rheumatology.

Aufgaben

• Assess and manage requests within Managed Access Programs and Named Patient Use frameworks, incorporating clinical and ethical perspectives.
• Develop comprehensive benefit-risk arguments while ensuring regulatory compliance.
• Collaborate with Regulatory Affairs, Legal, Pharmacovigilance and Commercial to shape access strategies.
• Prepare, review, and own CTD modules, expert statements, risk management docs and labeling texts.
• Maintain high scientific quality and consistency across regulatory deliverables, incl. ATMPs.
• Support regulatory strategies, briefing documents and interactions with global health authorities.

Kenntnisse

Medical degree (MD)

Regulatory expertise

Clinical trial experience

ATMP / cell therapy knowledge

Therapeutic area knowledge

Scientific writing

English fluent

German language advantageous

Ausbildung

Medical Doctor (MD)

Jobbeschreibung

• Assess and manage requests within Managed Access Programs and Named Patient Use frameworks, incorporating clinical and ethical perspectives
• Develop comprehensive benefit-risk arguments while ensuring compliance with regulatory requirements
• Collaborate closely with cross-functional teams including Regulatory Affairs, Legal, Pharmacovigilance, and Commercial to shape access strategies
• Prepare, review, and take ownership of clinical and regulatory documentation, including CTD Modules (Clinical Overview, Clinical Summary), expert statements, risk management documentation (RMPs), safety reports (PSURs / DSURs), and labeling texts (SmPC, CCDS, PIL)
• Maintain a high standard of scientific quality and consistency across all regulatory deliverables, including those related to complex products such as ATMPs
• Support the development of regulatory strategies, briefing documents, and interactions with global health authorities, including scientific advice procedures

Your Profile

• Medical degree (MD) is required
• Solid expertise in global drug development processes and regulatory requirements
• Proven experience across clinical trial phases (I-III), including medical monitoring and clinical practice
• Background in advanced therapies (e.g., ATMPs or cell therapies) is highly desirable, along with experience in early access programs and CTD authoring (especially Module 2)
• Therapeutic knowledge in areas such as oncology, hematology, immunology, or rheumatology
• Strong capability in scientific writing combined with the ability to convey complex information effectively
• Analytical mindset with a structured approach to benefit-risk evaluation
• Skilled in transforming scientific insights into strategic recommendations
• Fluent in English; additional German language skills are advantageous