Medical Expert (Clinical Research Physician)
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An orthopaedic and plastic surgery device distributor is partnering with Proclinical to seek applicants for a Field Service Engineer II vacancy. With a strong emphasis on surgical training and education, the company's representatives and surgeon consultants have created a network that provides practitioners easy and frequent exposure to market leading devices and techniques. This is an exciting opportunity to join the company's team in Germany.
Job Responsibilities:
- In the early development stages, you will take on the medical scientific responsibility for overseeing our aesthetic products and support us in evaluating external in-licensing opportunities.
- You will design and implement medical and scientific strategies for the clinical development of our medicinal products and medical devices, including new indications.
- With your medical expertise, you will contribute to the design of clinical studies and be responsible for clinical study protocols and clinical study reports according to current international regulations and Guidelines.
- As a medical expert within a multidisciplinary team, you will ensure medical plausibility and integrity of data and perform interpretations of study results.
- As a member of the Life Cycle Management team, you will provide clinical/medical knowledge on the preparation of documents in the context of maintenance for medicinal products and medical devices (e.g., investigator's brochure, instructions for use, PSUR/DSUR, clinical evaluation reports).
- You will be accountable for clinical sections for regulatory dossiers and medical aspects of interactions with regulatory authorities and notified bodies (e.g., participation in scientific advice meetings, answering List of Questions).
- You will actively contribute to the publications related to clinical data and present results at internal and external Symposiums.
Skills and Requirements:
- Doctor of medicine, preferably with PhD.
- Experience in clinical research (drug and/or medical device development) and/or expertise in aesthetic medicine/aesthetic plastic surgery.
- Experience preparing and giving medical scientific presentations.
- Ideally, knowledge of ICH-GCP, AMG, MED-DEV, MDR, and other relevant
- regulations/guidelines.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Russell at +44 203 824 6104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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