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Senior Medical Expert (m/f/d)
Frankfurt am Main
Aktualität: 24.11.2021

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24.11.2021, Merz Aesthetics
Frankfurt am Main
Senior Medical Expert (m/f/d)
You will provide medical/clinical guidance for the design and implementation of medical/clinical strategies during product development and life cycle management for the clinical development of our Aesthetic medicinal products and medical devices, including new indications in accordance with European and global regulatory requirements As a medical/scientific expert within a multidisciplinary team, you will ensure medical/clinical plausibility and integrity of data and perform interpretations of study results You will be accountable for clinical sections for regulatory dossiers and medical aspects of interactions with regulatory authorities and notified bodies (e.g., face-to-face, virtual and written communication, as well as submissions and responses to regulatory bodies) You will contribute knowledge and experience to the development, improvement and optimization of internal processes (e.g. in workshops and taskforces) You will actively contribute to the publications related to clinical study data and present results at internal and external symposiums You will provide clinical support to key business partners including but not limited to Commercial, Strategic Marketing, Medical Affairs and Legal
Doctor of medicine, preferably with PhD or PhD in Natural Science or Pharmacy Sound expertise in clinical research (drug and/or medical device development) gained from previous empolyment in the pharmaceutical industry or at an international CRO; experience in aesthetic medicine/aesthetic plastic surgery would be a plus Experience preparing and giving medical scientific presentations Ideally, knowledge of ICH-GCP, EU CT Regulation 536/2014, AMG, ISO 14155, MED-DEV, MDR, and other relevant regulations/guidelines Self-confident manner combined with strong communication skills - also fluent in business English Uncomplicated team player with positive can-do attitude and intercultural skills keen to join our international team of physicians and scientists

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