Medical / Scientific Expert (m/f/d), Clinical Development

Merz Aesthetics GmbH; Frankfurt; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Merz Aesthetics GmbH is seeking a qualified professional to lead clinical development activities in global programs, contributing to design, execution, and reporting of trials across devices, drugs, and biologics. The role requires strong regulatory writing skills and collaboration with international teams.

You will interpret diverse data, author regulatory documents, ensure GCP/ICH compliance, and support COA development, regulatory submissions, and publications in fluent English.

Qualifications

• Master's degree in Life Sciences, with a PhD or MD considered an advantage.
• 3+ years of experience in clinical development or clinical research within pharma, medical devices, biotech, or health sciences.
• Strong scientific and regulatory writing skills, including protocols, CSRs, investigator brochures, and regulatory modules.
• Solid understanding of global clinical development, trial methodologies, and regulatory frameworks (EMA, FDA, GCP, ICH, ISO 14155).
• Experience collaborating with multidisciplinary, international teams and managing multiple priorities.
• Strong problem-solving skills and proactive approach to challenges.
• High ownership, resilience, and adaptability in a fast-paced development setting.
• Professionalism, emotional intelligence, and collaborative mindset in stakeholder engagement.
• Comfortable with Microsoft Office tools and clinical documentation systems.
• Clear and effective communication of complex scientific data in writing and presentations, in fluent English.

Responsabilités

• Contribute scientific and strategic expertise to design, set-up, execution, and reporting of global clinical trials across the full product lifecycle.
• Collaborate with cross-functional and international teams to shape clinical development strategies for devices, drugs, biologics, and combinations.
• Integrate and interpret data from internal studies, external research, and literature to support clinical and regulatory decision-making.
• Author, review, and approve clinical documents including protocols, amendments, investigator brochures, CSR, and regulatory submission materials.
• Ensure all clinical documentation complies with global/regional regulations, GCP, ICH, ISO standards, and internal SOPs.
• Provide scientific input into regulatory interactions and submissions (IDE, IND, and marketing application dossiers).
• Support selection, development, and validation of COAs, including patient- and clinician-reported tools.
• Identify risks and propose solutions to keep projects on track.
• Prepare and present clinical trial results to internal stakeholders, scientific forums, and external partners.
• Support publication of clinical data via abstracts, manuscripts, and conference presentations.
• Oversee external medical writing vendors to ensure quality and compliance.
• Contribute to process improvements, trainings, and cross-functional initiatives.
• Support business development activities, including due diligence and in-licensing assessments when required.

Connaissances

Regulatory writing

Clinical development

Project management

Cross-functional teams

English proficiency

Formation

Master's degree in Life Sciences

PhD or MD advantageous

Outils

Microsoft Office

Clinical documentation systems

Description du poste

Merz Aesthetics is an independent, internationally active company in the field of aesthetic medicine. For years, our comprehensive product portfolio is among the highest quality in its category and is valued by healthcare professionals worldwide. Merz Aesthetics is part of the Merz Group, with our Europe , Middle East and Africa (EMEA) headquarters in Frankfurt am Main. Our global head office is located in Raleigh, North Carolina, USA. Our purpose is to help people look better, feel better, and live better, and over 3,000 employees across 26 countries are dedicated to this mission. Would you like to become part of our success story?

The following responsibilities are awaiting you:

• You contribute scientific and strategic expertise to the design, set-up, execution, and reporting of global clinical trials across the full product lifecycle.
• You collaborate closely with cross-functional and international teams to shape clinical development strategies for devices, drugs, biologics, and combination products.
• You integrate and interpret data from internal studies, external research, and scientific literature to support clinical and regulatory decision-making.
• You author, review, and approve high-quality clinical documents, including protocols, amendments, investigator brochures, clinical study reports, and regulatory submission materials.
• You ensure all clinical documentation complies with global and regional regulations, GCP, ICH guidelines, ISO standards, and internal SOPs.
• You provide scientific input into regulatory interactions and submissions, including meeting packages, IDEs, INDs, and marketing application dossiers.
• You support the selection, development, and validation of clinical outcome assessments (COAs), including patient- and clinician-reported tools and photo scales.
• You identify risks, troubleshoot scientific or operational issues, and proactively propose solutions to keep projects on track.
• You prepare and present clinical trial results to internal stakeholders, scientific forums, and external partners with clarity and consistency.
• You support the publication of clinical data by contributing to abstracts, manuscripts, and conference presentations in line with Good Publication Practices.
• You oversee and manage external medical writing vendors to ensure quality, consistency, and compliance with internal standards.
• You contribute to process improvements, internal trainings, and cross-functional initiatives to strengthen clinical development excellence.
• You support business development activities, including scientific due diligence and in-licensing assessments when required.

What we expect from you:

• You hold a Master's degree in Life Sciences, with a PhD or MD considered an advantage.
• You bring 3+ years of experience in clinical development or clinical research within pharma, medical devices, biotech, or health sciences.
• You demonstrate strong scientific and regulatory writing skills, including experience with protocols, CSRs, investigator brochures, and regulatory modules.
• You have a solid understanding of global clinical development, clinical trial methodologies, and regulatory frameworks (EMA, FDA, GCP, ICH, ISO 14155).
• You are experienced in collaborating with multidisciplinary, international teams and managing multiple priorities simultaneously.
• You show strong problem-solving skills and proactively address challenges in dynamic project environments.
• You demonstrate high levels of ownership, resilience, and adaptability in a fast-paced development setting.
• You engage stakeholders with professionalism, emotional intelligence, and a collaborative mindset.
• You are comfortable working with Microsoft Office tools and clinical documentation systems.
• You communicate complex scientific data clearly and effectively, both in writing and in presentations, in fluent English.

What you can expect from us:

Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our different internal and external support systems.

Family and work: Our employees should be able to reconcile their family and work commitments. That's why you'll find, for example, company day care centers at our locations. In the EMEA region, we have been awarded the "Top Employer" and "Great Place to Work" certifications for our outstanding HR policies and work culture.

Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flex-working time and mobile working. Our employees also benefit from generous arrangements for annual leave.

Ongoing training: Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.

Find out more about our benefits at https://careers.merz-aesthetics.com.