Freelancer profile translated to English.
Back to original languageAbout Elodie
Biologist by training and holder of a Specialized Master's degree in Innovation Management from ESCP-EAP, I have spent my career in project management and clinical development within the pharmaceutical and medical device industries. I have also developed expertise in strategy and organization.
From start-ups to big pharma, I have gained extensive experience in project management, outsourcing management, and clinical development for drugs, medical devices, and combination products.
Among my achievements, I can mention several drugs launched on the European and US markets, and a cell therapy in China. With this experience, I can support you in your current and future developments.
French
Native or bilingual
English
Fluent
Can work on-site
Lille (up to 50km)
Experience
- HC NEXTProject Manager Drug and Medical Device DevelopmentFebruary 2021 - Today (5 years and 4 months)Lille, FranceFor several different clients:- Planning and implementation of several Phase 1/2 clinical trials in neurology, traumatology, orphan indications, cell therapy- Review of development plans, review of protocols- Preparation of regulatory dossiers for trial submissions in France- Coordination of preIND meetings with the FDA- Budget, schedule, and deliverable management- Implementation of project portfolios and KPIs- Catch-up of clinical trials in a delayed situation- Implementation of RFPs, bid defense- Management of subcontractors
- MacopharmaStrategic Project DirectorJuly 2017 - December 2020 (3 years and 6 months)Tourcoing, FranceGovernance and Strategy• Rationalization of company projects, prioritization, structuring, alignment with strategic objectives• Implementation of a project portfolio governance system and innovation management• Leader of the innovation committee and PMO• Translation of the company's vision and mission into strategic BU objectives• Implementation of a project culture, processes, and project management tools (change management)• Management of 7 project managers and coaching of 4 project leaders• Definition of a market access strategy for the US and Chinese markets
- MacopharmaClinical Affairs Manager – Biotherapy BUDecember 2016 - June 2017 (6 months)• Implementation of the FP process in the company• Drafting of clinical evaluation reports, PMCF, benefit/risk balance assessment• Management of IIT clinical trials• Outsourcing management
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Education
- MOOC, Change ManagementESSEC Business School2020MOOC, Conduite du Changement
- Specialized Master's Degree, Innovate & EntrepreneurESCP Business School2000Mastère Spécialisé, Innover & Entreprendre