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Online Laboratory Magazine
02/26/2021

Manager Clinical Due Dilligence (m/f/d)


  • Graduate in natural sciences (Pharmacy, Chemistry, Biology, or equivalent)
  • Minimum 3 years' experience in clinical development or associated fields
  • In-depth pharmaceutical knowledge, in particular in pharmacokinetics, pharmacology, pharmacotherapy, pharmaceutical legislation, solid knowledge of GCP and of clinical trial design (especially bioequivalence studies) including basic statistics
  • Knowledge of worldwide regulatory requirements regarding development of medicinal products and bioequivalence studies
  • Ability to analyze, discuss, interpret and present pharmacokinetic, efficacy and safety data
  • Evaluate the appropriateness of clinical documents, clinical development plans or dossiers together with other functions (i.e. regulatory, medical) to verify compliance with internal quality standards, GxP and regulatory requirements for global submissions
  • Review the clinical documents in detail and prepare review summaries
  • Discuss a suitable clinical development plan with the partner where applicable
  • Assess potential risks for approval and prepare risk minimization strategies if feasible
  • Provide inputs to costs for additional clinical investigations and studies needed
  • Collaborate with and contribute the clinical expertise to a cross-functional team, manage exchange of information
  • Provide inputs to contract negotiations and budget planning where applicable
  • Collaborate and contribute to responding to deficiency letters as needed


» Job description


Employer:
Hexal AG
Location:
83607 Holzkirchen
Temporary:
Yes
Part-time:
Yes