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Senior Scientific / Medical Expert (m/f/d), Post-Market & Life Cycle Management, R&D Clinical Development
Merz Aesthetics
Frankfurt am MainOn-siteFull-Time3w ago
Description
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? Join Merz Aesthetics!
The following responsibilities are awaiting you:
- You provide medical/scientific and clinical guidance for strategic decision-making in product development and life cycle management, including engagement with KOLs, advisory boards, and regulatory authorities.
- You design and oversee clinical study outlines and coordinate the creation of clinical study protocols (incl. amendments) and clinical study reports in compliance with development strategies/post-market requirements ensuring high scientific standards.
- You are responsible for the medical/scientific input during the conduct of clinical development, life cycle management and post-market projects and studies ensuring high-quality study design, and timely project delivery within scope and budget.
- You ensure data integrity and medical/scientific plausibility of clinical data and statistical outputs (raw data).
- You are responsible for the medical/scientific input for clinical parts of key regulatory and project documentation for medicinal products and medical devices ensuring compliance with global requirements including but not limited to Clinical Evaluation Report, Summary of Product Characteristics, Investigator Brochure, Instructions for Use, Post market clinical follow up (PMCF) plan/report, DSUR, PSUR, Common Technical Document, briefing packages/list of questions for scientific advice meetings and public disclosure data sets.
- You provide medical/scientific guidance for activities related to the development/validation of project specific clinical outcome assessments (COAs) for clinical studies.
- You develop clinical development plans aligned with regulatory requirements to support global market approvals and new indications for existing products.
- You support medical/scientific evaluation and guidance for due diligence activities, including in-licensing opportunities and assessment of internal and external project ideas.
- You collaborate cross-functionally with R&D, regulatory, and commercial teams to drive innovation, ensure alignment, and support successful product lifecycle management.
What we expect from you:
- A medical or master’s degree in Life Science, preferably with MD, PhD, DrPH, PharmD, or equivalent.
- You bring 8+ years of strong medical/scientific and clinical expertise within clinical development, ideally in a global environment, experience in aesthetic medicine as a plus.
- You show experience and competence in clinical research design and methods for the clinical development of medicinal products and medical devices, including working knowledge of relevant regulatory requirements and regulations, ICH and GCP guidelines, and in critical review of scientific literature and essential clinical trial documents.
- You demonstrate excellent interpersonal and social skills with strong leadership capabilities, enabling you to guide cross-functional teams to trust and foster collaboration and the ability to influence decision-making, and drive alignment.
- You engage effectively with internal and external stakeholders, including senior leadership, KOLs, and regulatory authorities.
- You work in a structured, quality-focused manner with a strong commitment to timelines and deliverables.
- You communicate complex medical/scientific and clinical topics clearly and convincingly to d
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