We have an exciting opportunity for a senior experience with quality and compliance experience gained in medical affairs / clinical development area to support medical governance activities for post marketing studies.
• Onboard, support, train, coach and mentor country MGLs ensuring that a strong, motivated and knowledgeable team is built within the geographical area of responsibility.
• Monitor adherence to required processes and standards within the assigned geographical area of responsibility, Support data quality/integrity in activities conducted within the assigned geographical area of responsibility.
• Maintain overview and monitor progress of quality issues related to the assigned geographical area of responsibility, ensure & track escalation and follow-up until resolution.
• Ensure regular review, assessment and follow-up of key performance, quality, and risk indicators. Support, guide and maintain oversight of country MGLs in implementing and performing MA Health
• Ensure that compliance gaps and risks are addressed and mitigated by identifying appropriate opportunities for continuous improvement and leading design and implementation of corresponding actions.
• Maintain oversight and monitor local audit & inspection readiness and execution within the assigned geographical area of responsibility, in close collaboration with respective QA function.
• Maintain oversight and monitoring of deviation and CAPA management process for GxP activities, supporting the G/R/C teams in development of robust CAPAs arising from self-identified deviations, audits, and inspections and ensuring that CAPAs are appropriately documented, tracked, monitored, and followed up, and that appropriate action is taken when CAPA is at risk of becoming overdue or being ineffective.
Requirements: Scientific Degree, PhD, PharmD or equivalent.
• Extensive and relevant experience in Medical Affairs and/or clinical development of medicines (at least 7-10 years).
• Both scientific and operational aspects of clinical drug development and Medical Affairs.
• ICH GCP and respective national/supranational regulations within the assigned geographical area of responsibility.
• Leadership and proven planning and management skills.
• Strong communication and ability to communicate complex information in simple terms.
• Previous experience in a country regional role required.
• Strategic thinking and change management mindset to sustain a culture of high ethical standards and compliance.
This is 12 months contract and requires some presence in Switzerland
Michael Bailey International is acting as an Employment Business in relation to this vacancy.