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Novartis Pharma AG
- Global Head, Oncology Submission Management Group
RUEIL MALMAISON
2008 - maintenant
As Global Head of the Oncology Submission Group (OSG), I manage and optimize resources and operational activities to ensure timely production of high quality submission documentation across all programs in the Oncology Business Unit. I oversee day to day operations OSG and ensure adequate staffing of programs, while identifying issues and resource gaps to ensure their resolution.
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Novartis Pharma AG
- Oncology Submission Manager
RUEIL MALMAISON
2007 - 2008
For first submissions of large dossiers to Health Authorities (HA) and related follow-up activities (e.g. NDA, sNDA, Variations, 120-Day Update Reports, Answers to HA Questions, Briefing Book, Oral Explanation and Advisory Committee), to plan, lead and coordinate tasks to support the timely delivery of high quality documents as well as managing the logistical aspects of building the clinical sections of a submission dossier.
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Novartis Pharma AG
- Expert Medical Writer
RUEIL MALMAISON
2004 - 2007
I have been a major contributor together with the clinical authors to CTD modules (SCS, SCE and/or CO) in over 18 NDAs/sNDAs in the fields of oncology, cardiology, infectious diseases, and neuroscience. I have also been an author or contributor for Answers to HA Questions, 120 Day Safety Updates, Risk Management Plans and white papers for HAs. I have written over 40 phase II and III clinical study reports in oncology, cardiology, infectious diseases, dermatology, respiratory and NS. The writing of these documents entailed a coordinating role among the different authors (clinical, safety, statistics and others) and an advisory role to help teams understand the required structure and content of the documents as per internal and/or regulatory guidelines. As an expert medical writer, I have also mentored junior members of our group and contributed to templates and SOPs when needed.
Member of the Protocol Templates Revision Working Group, Clinical Development Operations Communication Team, electronic Protocol Business Team.
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Freelance
- Medical Writer and Translator
2003 - 2004
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Bowne Global Solutions
- Global Project Manager
2000 - 2003
As a Global Project Manager I oversaw all cost and production aspects of large multi-language translation, localization and technical writing projects for major customers in the fields of pharmaceuticals and medical devices. My responsibilities included project analysis and preparation, planning and scheduling, quoting and budgeting, resource allocation and cross-functional team management (up to 20 direct reports for a given project), budget tracking, risk and change management, as well as ad-hoc communication with suppliers and reporting to customers. I was also responsible for implementing efficient project management strategies to reduce time and costs, thus ensuring the financial viability of the projects. My second main function was to interact with existing customers in order to increase our cooperation and to meet with potential new customers together with the sales team in order to explain our capabilities and offer tailored solutions to their needs.
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PH Brink
- Language Group Coordinator
1999 - 2000
As a Language Group Coordinator I was responsible for job assignments, tracking and monitoring of projects and progress reporting within the French Dept. (8 direct reports) and Greek Dept. (2 direct reports). I also worked towards minimizing downtime and monitoring individual and group efficiency. I was responsible for meeting or exceeding project/customer deadlines, and delivering projects to the highest possible standards.
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ASTER-CEPHAC
- Medical Writer
1996 - 1999
This position in a C.R.O. allowed me to gain considerable knowledge in the fields of patient monitoring and clinical reporting. As a medical writer I was in charge of several customers with whom I had daily contacts. I also had meetings with the in-house investigators and biostatisticians, during which the outline of the data presentation would be decided and their significance discussed, both from a clinical and a statistical point of view. The studies were mainly dose-finding and safety studies in the fields of cardiology, dermatology and ophthalmology. On an ad-hoc basis, I also designed templates for investigator's brochures, protocols and reports according to regulatory and customer guidelines.
I also acquired experience in medical translations from both English and German into French.
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Ecole Interarmées du Renseignement et des Langues
- Military Interpreter-Translator
1995 - 1996
Interpreter, tranlator, and language instructor during military service
