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Medical Affairs Governance & Compliance Manager (f/m/d) 100% [ID: 33911]

Nemensis AG

 
Basel-Stadt
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Nemensis AG
Medical Affairs Governance & Compliance Manager (f/m/d) 100% [ID: 33911]

At nemensis ag, we have connected thousands of applicants with their dream job and given them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Basel, we are looking for a Medical Affairs Governance & Compliance Manager (f/m/d).

Your responsibilities:

  • Medical governance monitoring and business analyst including as needed:
    • Conduct ad-hoc reporting requests for management or stakeholders
    • Conduct root cause or trend analysis
  • Support Oncology Global Medical Affairs and broader Oncology Medical Affairs (OMA) on the monitoring and follow-up of actions based on data from OMA View for Medical Affair activities
  • Define business requirements on new reporting requirements; works with implementation team on the implementation
  • Manages the "health check" process including process design updates or training
  • Supports the training, testing and rollout of the reporting solutions
  • Coaches, develops and supports OMA team in use of monitoring tools

Your profile:

  • Minimum: Scientific qualification (PhD, MSc or Bachelor's Degree) in an appropriate scientific discipline, quality-related field with an in-depth knowledge of the international pharmaceutical product development process, or degree from an accredited college or university.
  • Preferred: minimum of 2 years' experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
  • Proven strong analytical, planning and executional skills
  • Able to understand and work with enterprise and functional systems & data
  • Strong skills to interpret business requirements (including metric definition)
  • Experienced in implementing and deploying projects/ changes in an organization
  • A broad understanding of Quality Management, GCP / GVP and Risk Management processes
  • A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines
  • Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies

For further questions, please contact: Nicolas Gerster, 061 205 98 69, Click to send email

Nemensis AG
Basel-Stadt

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