Senior Medical Expert (m/w/d)

Location Basel, Switzerland
Job type Permanent
Salary €110000 - €130000 per annum + package negotiable
Start date ASAP
Contact Marlene Inderhees
Job ref 10_2021_1612976742

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.

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