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Merck
- Médical Advisor Fertility
Lyon
2016 - maintenant
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Merck Serono
- Medical Advisor - Oncology / Endocrinology/Fertility
Lyon
2014 - 2016
- Clinical trial : inclusions follow up, budget follow up, communications (publications, posters, abstracts, newsletters, investigators meetings,...)
- Project management in Medical Affairs in order to improve knowledge and communication on the company drugs: communication with medical experts,
- Fellowships : program constitution with experts, monitoring of registrations, communications,
- Elaboration of medico-marketing campaigns and medico-marketing strategic plans
- Constitution of training documents and oral training with medical representants,
- Medical validation of promotional and non promotional materials,
- Congress preparation (selection of abstracts, etc) and summaries elaboration,
- Medical representative for the French affiliate company.
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Merck Serono
- Regulatory Affairs Manager
Lyon
2013 - 2014
Marketing Authorization:
- Centralized, Decentralized/Mutual Recognition, National Procedures
- Worksharing and "grouped variations" procedures
- Management of CTD, eCTD, Nees formats
- Constitution of Marketing Authorization dossier and submission to ANSM,
- Management of variations (all procedures) : constitution of folders, submission to ANSM, update of SmPC and patient leaflet after approval,
- Proof reading for Artworks
- "Corporate Lead" responsability for one product with management of approximately 20 countries (enlarged Europe)
Clinical Trials
- Constitution of folders for new clinical trials and submission to ANSM and CPP,
- Management of substantial and non substantial changes: constitution of folders (protocol amendment, update of investigator brochure, etc) with preparation (if needed) of comparative tables, supportive documents, etc, and submission to ANSM.
Other activities
- Pharmaceutical advertising control,
- Regulatory vigilance
- Translation activities,
- Participation in updating internal procedures,
- Relationship with headquarter Merck Darmstadt,
- Transversality with : Medical information, Pharmacovigilance, Marketing, Regulatory Compliance, Quality assurance
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GlaxoSmithKline
- Regulatory Affairs - Internship of Pharmacy
Marly-le-Roi
2012 - 2013
November 2012 - May 2013 : Oncology, HIV, Infectious disease, Respiratory, PAH
May 2013 - November 2013 : NCS, Rheumatology, Urology, Parasitology, Vaccines, Cardiology, Thrombosis
Marketing Authorization:
- Centralized, Decentralized/Mutual Recognition, National Procedures
- Worksharing and "grouped variations" procedures
- Management of CTD, eCTD, Nees formats
- Constitution of Marketing Authorization dossier and submission to ANSM,
- Management of variations (all procedures) : constitution of folders, submission to ANSM, update of SmPC and patient leaflet after approval,
- Proof reading for Artworks
- Comparaison of national annexes with GlobalDataSheet of headquarter, and update for harmonization.
Clinical Trials
- Constitution of folders for new clinical trials and submission to ANSM,
- Management of substantial and non substantial changes: constitution of folders (protocol amendment, update of investigator brochure, etc) with preparation (if needed) of comparative tables, supportive documents, etc , and submission to ANSM.
Other activities
- Participation in dossier for obtention of reimboursment (with medico-economic department)
- Regulatory vigilance,
- Translation activities,
- Participation in updating internal procedures,
- Relationship with headquarter GSK UK,
- Transversality with : Medical information, Clinical Operations, Pharmacovigilance
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CHU Grenoble
- Internship of Pharmacy
Grenoble
2009 - 2012
May 2012 - November 2012 : Central Sterilization Department
- Stock management,
- Traceability monitoring,
- Audits management,
- Monitoring and analysis of quality indicators,
- Versatility in guards.
November 2011 - May 2012 : Regional Pharmacovigilance Center
- Answers to questions from health professionals,
- Collection, evaluation, and documentation of cases,
- Communications and reports to health authorities.
May 2011 - November 2011 : Infectious Diseases Department
- Prescriptions validation,
- Answers to questions from health professionals, participation on visits and medical staff,
- Pharmaceutical interviews and patient education,
- Versatility in guards.
November 2010 - May 2011 : Hospital Pharmacy – Psychiatry Specialized Hospital of Saint-Egrève
- Prescriptions validation,
- Answers to questions from health professionals, participation on medical visits,
- Drugs and medical devices dispensation,
- Make lesson to nurse students on antibiotics.
- Versatility in guards.
May 2010 - November 2010 : Pneumology Department
- Prescriptions validation,
- Answers to questions from health professionals, participation on visits and medical staff,
- Pharmaceutical interviews and patient education.
November 2009 - May 2010 : Hospital Pharmacy – Chambéry’s Hospital
- Pharmacovigilance and matériovigilance management,
- Participation in marketing of medical devices and tenders,
- Versatility in guards.
