We have an exciting opportunity for experienced medical affairs compliance manager to join a project to oversee implementation of medical affairs operational processes and projects.
• Medical governance monitoring and business analyst including as needed
• Conduct ad-hoc reporting requests for management or stakeholders
• Define business requirements on new reporting requirements; works with implementation team on the implementation
• Supports the training, testing and rollout of the reporting solutions
• Coaches, develops and supports OMA team in use of monitoring tools
• 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.
• 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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.