-
The Kirby Institute
- Clinical Project Coordinator
2013 - maintenant
-
Abbott Laboratories
- Regulatory Affairs Associate
Rungis
2013 - 2013
Managed the preparation, submission and maintenance of registration applications of prescription medicines to the TGA and Medsafe
- Category 3, Safety-related request and Self-assessable request Applications in Australia
- Change Medicine Notification and Self-Assessable Change Notification in New-Zealand
- GMP clearance
- Maintenance and revision of Product Information, Datasheet, Consumer Medicines Information and labelling for registered products in accordance with relevant regulations
- Liaised with internal departments locally and internationally
- Liaised with regulatory bodies
- Kept up to date with regulatory changes
-
Servier
- Non clinical study manager
Suresnes
2008 - 2013
Rheumatology Therapeutic Division, Suresnes, France
•Non-clinical pharmacology studies
- Personally responsible for external small molecule pharmacological studies, in rare diseases (drug in early development) and more common indications affecting the musculoskeletal system (drug in Phase II)
-Worked as part of a team to select partner academic laboratories and Contract Research Organizations (CROs)
-Led study protocol writing and reports, and interpreted study results
-Played a central role in the coordination process between the study investigator, the CROs and international Servier’s partner
-Submitted file to the Ethics Committee
•Clinical studies
-Worked as part of a team to write the pharmacokinetic part of study protocols for Phase II and Phase I Pharmacokinetic studies
-Managed the pharmacogenetic part of a Phase II monocentric clinical trial
-Responsible for sub-contracting the logistics of biological samples for a Phase II monocentric and Phase I Pharmacokinetic studies
-Wrote Investigator’s Brochures
-Fielded questions relating to a Phase II clinical trial to the Regulatory Authority
•Project team member for 2 drugs: “Non-clinical and Kinetic Coordination”
-Responsible for the non-clinical pharmacology development plan and the pharmacokinetics within clinical studies
-Worked in interaction with all team members (pharmacokinetics, toxicology, pharmaceutical development, etc.)
•Managed a 6-month trainee
-
Servier
- Clinical study manager trainee
Suresnes
2007 - 2007
Cardiovascular Therapeutic Division, Courbevoie, France
Phase III
- Participated in pharmacovigilance and medical review process
- Wrote procedures, reviewed study documents
