Principal Clinical Consultant - Medical Expert (m/w/d) | Freiburg | Pharma
Our client is a medium sized pharmaceutical company specialising in clinical and pharmaceutical development, regulatory affairs, and market access. The company, located near Freiburg and founded in 1994, is representative in more than 90 other continents worldwide.
What will your tasks as Principal Clinical Consultant - Medical Expert be?
- Clinical development plan for medicinal products and medical devices incl. design and planning of clinical trials.
- Preparation of documents for marketing authorisation and other documents required for the development of medicinal products (e.g. M 2.5, 2.7 of the CTD; Investigator's Brochure, Risk Assessments)
- Clinical-regulatory review of marketing authorisation dossiers and clinical data sets about their acceptability by European authorities for marketing authorisation
- Preparation and management of scientific consultations with national medicines authorities and the EMA
Your requirements as " Principal Clinical Consultant - Medical Expert "?
- Degree in university studies, preferable in human medicine with higher qualification (e.g. doctorate, specialist)
- Extensive experience (min. 10 years) in the field by working in the pharmaceutical industry or in a clinical research organisation (CRO)
- Knowledge of regulatory requirements for all phases of clinical drug development
- Experience in the preparation of regulatory documents related to CTA, MAA
- English: fluent in spoken and written, German advantage
They will offer you?
- Type of contract: unlimited full-time
- Holiday: 30 days / year + extra holiday
- Homeoffice: 90% remote / mobiles
- Working hours: 40 hours / week
- Access: On-site parking and very good public transport connections public transport
- Start date: As soon as possible
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/
Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!
I look forward to your application!