Medical Affairs Compliance and Governance Manager- contract
Posted on Jul 16, 2021 by Michael Bailey Associates - Zurich
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 (eg FDA, EMEA) and ICH regulations and guidelines.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.