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Offre d'emploi: medical affairs governance & compliance - insights and operations

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job details

   . 22. juillet 2021
   . basel, bâle-ville
   . life sciences
type d'emploi
   . contract
   . 16238
   . jirel kuenen, bâle professionals health care & life sciences
   . 058 201 54 40
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description du poste

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 needed
a. Conduct ad-hoc reporting requests for management or stakeholders b. Conduct root cause or trend analysis
2. 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 activities
3. Define business requirements on new reporting requirements; works with implementation team on the implementation
4. Manages the ?health check? process including process design updates or training
5. Supports the training, testing and rollout of the reporting solutions
6. 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


Job Category: Legal [ View All Legal Jobs ]
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Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
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Company Type Employer
Post Date: 07/21/2021 / Viewed 3 times
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