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Phase IV Manager in Governance...

Sandoz Germany
Sandoz develops, manufactures and markets patent-free medicines and complex, innovative pharmaceuticals. In Germany, Sandoz is the leading provider of patent-free medicines with its product brand Hexal. Hexal products offer doctors, pharmacists and patients a broad range of treatment options. They stand for competence in research and development, for good service and economic supply. Sandoz produces Hexal drugs at several locations in Germany.
Phase IV Manager in Governance, Compliance and Services (m/f)

Business Unit:BioPharma SZ
Company/Legal Entity:Germany Hexal Aktiengesellschaft Holzkirchen
Job Reference Code:234089BR


  • Implement quality and compliance standards (based on applicable internal policies and regulations) for key operational activities and processes related to the conduct of local phase IV studies/ NIS within Global Medical Affairs organization
  • Participate in remediation or quality enhancement projects or management of non-conformances related to medical affairs activities and provide ongoing project support and governance as assigned
  • Support remediation plans for global implementation where identified as potential systemic gap in global/ local Medical Affairs organizations
  • Ensure global oversight processes are implemented according to applicable procedures for the local Phase IV studies/ NIS/ IITs in scope during conduct until final report.
  • Provide support to global/ local Medical Affairs organizations, in case of health authority inspections by providing input to responses and corrective action plans to the inspection findings related to local Phase IV studies/ NIS/ local IITs
  • Provide guidance and training to global/ local Medical Affairs organizations on GPP, GCP, PV, quality and compliance aspects related to the conduct of local Phase IV studies/ NIS and support of IITs


  • Master’s degree in Life Science, Healthcare or equivalent
  • 3+ years relevant experience in the pharmaceutical industry with focus on clinical study conduct and/ or clinical quality assurance
  • Good knowledge of the legal and regulatory requirements related to clinical studies
  • Excellent English written and verbal communication, presentation and negotiation skills
  • Excellent team player, experienced in working in a multidisciplinary international environment
  • Strong organizational skills; ability to coordinate a number of tasks simultaneously and prioritize
  • Ability to accurately work under time pressure

We offer: Excellent employee benefits, interesting and challenging tasks and the chance to join a dynamic team. Please apply online via our Online-Tool and include your CV and copies of references. Please also state your salary expectations and your earliest availability to start work.

Please note we only accept online applications. For more information, please refer to our career website: www.novartis.com/careers


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