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    • basel, basel-stadt
    • contract
    For one of our client in Basel we are looking for a Medical Affairs Governance & Compliance - Insights and Operations Lead, for a 11 months contract.Responsibilities:1. Medical governance monitoring and business analyst including as neededa. Conduct ad-hoc reporting requests for management or stakeholders b. Conduct root cause or trend analysis2. 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 activities3. Define business requirements on new reporting requirements; works with implementation team on the implementation4. Manages the “health check” process including process design updates or training5. Supports the training, testing and rollout of the reporting solutions6. Coaches, develops and supports OMA team in use of monitoring tools Relevant Experience: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 - a minimum of 2 years’ experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities. Experience, Skills, Knowledge:? 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.? Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.? Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies
    For one of our client in Basel we are looking for a Medical Affairs Governance & Compliance - Insights and Operations Lead, for a 11 months contract.Responsibilities:1. Medical governance monitoring and business analyst including as neededa. Conduct ad-hoc reporting requests for management or stakeholders b. Conduct root cause or trend analysis2. 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 activities3. Define business requirements on new reporting requirements; works with implementation team on the implementation4. Manages the “health check” process including process design updates or training5. Supports the training, testing and rollout of the reporting solutions6. Coaches, develops and supports OMA team in use of monitoring tools Relevant Experience: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 - a minimum of 2 years’ experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities. Experience, Skills, Knowledge:? 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.? Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.? Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies

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