Agnieszka Sadowska
Roma
Summary
PhD in Life Sciences and several years in R&D of the multinational pharmaceutical company and academy. As regulatory associate responsible for post-market monitoring and surveillance of the medical devices. Direct contact with regulatory authorities. Experience as a Study Director of the CRO, pre-clinical settings. Practice with writing variety of documents: study protocols and reports, SOPs, data sheets and application for licenses. Proven skills in people management. Experience in leading cross-functional projects during drug development. I am convinced that my strong interest in regulatory framework of medical devices, capacity to quickly grasp new concepts as well as my resilience will be bringing tangible benefits to your team
Overview
16
16
years of professional experience
Work History
Research scientist and lab manager
EMBL- Epigenetics and Neuroscience Center
05.2018 - Current
- Supervision of the multiple research projects, guidance of the new team members;
- Responsible for interaction with external and internal facilities, manufacturers and suppliers
- Maintenance up to date laboratory data bases, protocols and SOPs.
RA associate
Halyard Health
09.2017 - 04.2018
- Responsible post-market surveillance and reporting of the adverse events
- Primary contact for regulatory authorities EMEA and MHRA.
Scientist
Janssen Pharmaceutica (contract)
11.2011 - 06.2015
- Member of R&D Neuroscience team
- Developed cellular models for AD drug screen
- Experienced in HTS and profiling of NCEs
- Manager of the two multi stakeholders’ projects
- Responsible for material and data transfer between the partner teams, organized kick-off and follow-up meetings.
Study Director of CRO
reMYND
05.2010 - 11.2011
- Designed and executed multiple projects using transgenic mouse models.
- Principal contact with the sponsors; coordinated activities of five scientists, scheduled work-plans, wrote study protocols, study reports and SOPs.
- QC officer, member of ethical commission.
Scientist
Janssen Pharmaceutica (contract)
09.2008 - 05.2010
- Responsible for assay development and HTS compound screens in the contest of AD and PD.
Education
PhD in Life Sciences -
European Molecular Biology Laboratory (EMBL) And Heidelberg University
01.2003
Master of Science - Biotechnology
Medical University
Gdansk, Poland07.1999
Skills
- Communication
- Cultural and emotional intelligence
- Persistence
- Good time management
- Adaptability
- Persuasion
- Work ethic
- Proficiency MS Office and statistics
Languages
English
fluent
Italian
fluent
Polish
native
German
basic
Awards
Fellowship of UNESCO-L’Oréal for Young Women in Science 2005
Training
- Project management - PRINCE2 Foundation, Belgium, 2015
- Conduct of clinical trial and data interpretation- KU-Leuven, Belgium, 2008
- Writing and analysis of systematic reviews on clinical trials- KU-Leuven, Belgium, 2008
- Clinical Research Training for CRAs- European Center for Clinical Research Training, Belgium, 2007
Timeline
Research scientist and lab manager
EMBL- Epigenetics and Neuroscience Center
05.2018 - Current
RA associate
Halyard Health
09.2017 - 04.2018
Scientist
Janssen Pharmaceutica (contract)
11.2011 - 06.2015
Study Director of CRO
reMYND
05.2010 - 11.2011
Scientist
Janssen Pharmaceutica (contract)
09.2008 - 05.2010
PhD in Life Sciences -
European Molecular Biology Laboratory (EMBL) And Heidelberg University
Master of Science - Biotechnology
Medical University
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