Senior Medical Affairs Analyst
1 semana atrás
The Sr. Medical Affairs Analyst will be responsible for supporting the procedural documents activities, scientific affairs investigations, change project management and processes improvements initiatives.
**Key Role Activities**:
This function supports the procedural documents activities, operations investigations, change project management and processes improvements initiatives related to Scientific Affairs-Latin America. It requires interaction with local and regional Medical Affairs and Commercial teams. The main activities are:
- Be responsible for supporting the procedural documents and change project management covering all scientific affairs areas. It requires a close interaction with local, regional, and global stakeholders, within and outside Medical Affairs, such as Scientific Affairs, Product Quality Vigilance, BRQC, Commercial Quality and others;
- Be responsible for performing data science analyses related to scientific operations and other MAF activities;
- Support SA process improvements managing the end-to-end activities related to it (Define, Measure, Analyze, Improve and Control);
- Interface with MAF local team to identify impact and needs for regional process improvements;
- Responsible for monitoring SA process performance indicators;
- Proactively seeks out opportunities to collaborate and solve problems as a team and maximize performance focusing on all Scientific affairs areas;
- Lead and perform the applicable alignments with impacted areas involving investigation of issues related SA;
- Work in partnership with SA areas to support the change management of projects involving the regional and local areas;
- Pre-audit preparation, audit support and management of corrective actions, preventive actions and effectiveness check as post-audit activity related to Medical Affairs Area.
**Qualifications**:
- Bachelor’s or higher degree in preferentially in a healthcare area (pharmaceutical, biochemical or chemical/production engineering);
- Proficient in Portuguese (oral and written); advanced English and intermediate Spanish;
- 3-5 years of experience in managing and implementing Processes, mapping, improving and optimizing processes;
- Desirable previous experience in a quality management system or process excellence in the medical device and/or pharmaceutical industries;
- Experience with non-conformance investigations techniques;
- Process excellence knowledge;
- Knowledge of data science tools;
- Analytical skills to diagnose and manage demands;
- Quality & Compliance or correlated areas developing activities related to controlled procedural documents and quality issues/CAPAs;
- Knowledge in Office package tools;
- Good Communication skills;
- Home Based Position.
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