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Medical Expert Manager (m/w/d)

Medical Expert Manager (m/w/d)

Job Title: Medical Expert Manager (m/w/d)
Contract Type: Permanent
Location: Konstanz, Baden-Württemberg
Industry:
Salary: €100000 - €130000 per annum + package negotiable
Start Date: ASAP
Reference: 03_2021_1611056179
Contact Name: Marlene Inderhees
Contact Email: m.inderhees@sciproglobal.de
Job Published: January 19, 2021 11:36

Job Description

Medical Expert Manager (m/w/d) | Konstanz | Pharma

You would like to have your workplace at Lake Constance?

You like to work from home and still be in contact with other medical experts?

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.