Senior Medical Expert (m/w/d) | Basel| Pharma
You are a medical doctor and already have professional experience in clinical development?
If you would like to experience this in a medium-sized company from the pharmaceutical industry, then you have come to the right place!
What will your tasks as Medical Expert be?
- Regulatory evaluations and scientific assessment of registration dossiers
- Medical input into regulatory strategy and feasibility assessments
- Clinical development planning including design and planning of studies
- Response to clinical deficiency letters as part of the drug approvals process
- Clinical input to and/or authoring and compilation of clinical documentation, including
- Common Technical Dossier (CTD) for medicinal products
- Risk Management Plans, Risk Assessments
- OTC Switch ReportsoOrphan drug applicationso
- Paediatric investigational plans
What does the position offer you?
- Type of contract: unlimited + full time
- Vacation: 31,5 days / year
- Working hours: 40 hours / week
- Accessibility: On-site parking and very good public transport connections
- Start date: As soon as possible
- Medical doctor, preferably with higher qualification (e.g. PhD)
- Several years of experience in clinical development and/or clinical trials
- Used to working in a regulated environment, especially knowledge of GCP and other relevant regulations/ guidelines
- Excellent written and oral communication skills in English
I look forward to receiving your application.