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Compliance Partnerships Leader SRS 5070

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. 

This role requires a candidate that proactively identifies compliance needs, leading and supporting the creation of solutions including processes or other initiatives to sustain the clients license to operate and improve patient outcomes.

Creating the appropriate environment within PDMA to enable compliance ensuring that Medical Affairs activities are executed efficiently, effectively and in accordance with SOPs, policies, regulatory requirements and guidelines.

Main Responsibilities:

  • Leading and supporting the design and implementation of holistic, company-wide standards and solutions to establish the framework and the execution of Market Research And Patient Support Programs (MAPs) and Evidence Generation in accordance with Scientific Credibility standards (including Real World Evidence Scientific Projects), collaborate with the relevant stakeholders at all levels.
  • Communicating, providing leadership and guidance to Affiliates, Global Functions and other key stakeholders addressing PDMA related process requirements and regulations
  • Acting as Subject Matter Expert (SME) during Inspections and Audits, ensure Inspection
  • Readiness and support for the preparation of responses to findings and the development and implementation of Corrective Actions and Preventive Actions (CAPA)
  • Ensuring the right PDMA audience is assigned to relevant trainings and foster an overall culture of adherence to quality and business requirements

 

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Life sciences degree or nursing equivalent or substantial experience in a clinical research/healthcare/pharma environment
  • 7 to 10 years experience in the pharmaceutical or health sector (clinical trials, quality, safety)
  • Experience in quality management with digital activities
  • Extensive experience in GCP, GVP and healthcare compliance
  • Fluency in written and spoken English
  • Demonstrates basic knowledge in digital technologies
  • Have an overall understanding of the activities conducted in Medical Affairs
  • Embed the Pharma Operating Principles in the way of working, including customer-centric mindset.

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