Medical Expert (m/f/d) | Mainz | Pharma
In this role you will collaboration with a multi-functional and global team. Do you want to share an enthusiasm for customer-oriented work and are willing to take up the task of continuing to write a success story?
What will your tasks as Medical Expert be?
- Responsible for clinical study protocols and clinical study reports, including the interpretation of study data and study results
- Advice on the design and implementation of medical-clinical strategies during product development and life cycle management for the clinical development
- Supervision of medical / clinical-scientific responsibility for the products and support in the evaluation of external in-licensing options including advice with internal and external experts (e.g. key opinion leaders)
- Providing of medical / clinical knowledge for the creation of documents in the context of the maintenance of drugs and medical devices (e.g. investigator brochures, specialist information, instructions for use, PSUR / DSUR, clinical evaluation reports, PMCF plans and reports, SSCPs)
- Responsible for clinical sections for regulatory dossiers and medical aspects of interaction with regulatory authorities and notified bodies (e.g., face-to-face, virtual, and written communication, as well as submissions and responses to regulatory bodies)
- support the key business partners including but not limited to Commercial, Strategic Marketing, Medical Affairs and Legal
What does the position offer you?
- Type of contract: unlimited + full time
- Vacation: 30 days / year
- Working hours: 39 hours / week
- Start date: As soon as possible
- Location: Mainz - 1-2 day of Home office
- Benefits: Personal & professional development
- Salary: 13 + variable part
- Doctor of medicine - preferred PhD or Pharmacy
- Several years of experience in clinical research (drug and/ or medical device development) in the pharmaceutical industry or at an international CRO
- Experience in plastic surgery (benefit)
- Knowledge of ICH-GCP, AMG, ISO 14155, MDR or other relevant regulations/ guidelines
- Excellent written and communication skills in English
- Experience preparing and giving medical scientific presentations
Information about our client:
Our client is a leading pharmaceuticals & medical devices companies in Europe. The company is more than 100 years old and it's more than 3000 employees are operating in 50+ countries. The diverse specialties of the company include medical aesthetics and neurotoxin therapy. The company is also active in research, development, and distribution of further innovative products (innovative health, wellness and beauty).
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I look forward to your application!