Senior Medical Expert (m/w/d)

Job description

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

Your requirements?

• 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.