Looking for new opportunity in regulatory affairs, scientific writing, medical affairs, publication management, intellectual property or EU and national funding projects.
Undergoing the "Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)" – RAPS on-line training, since August 2016
- Strong expertise in writing of technical and scientific documentation
- Publication management
- Excellent understanding of intellectual property related matters, management of paper and electronic laboratory notebook systems
- Implementation of SOPs and trainings
- In-depth involvement in research processes and associated European and national funding schemes, including preparation of application forms, project management and reporting
- Proven project management and project planning capability, with constant focus on best solutions for end-users
- Familiar with environmental, health and safety standards literature related to chemistry
- Strong capacity to analyze, assimilate and summarize information
- Cross-functional team leadership: coordination and communication skills, ability to interact with multiple stakeholders
- Demonstrated initiative, flexibility and organizational abilities
- Ability to influence and convince in a non-hierarchical relationship
- Broad knowledge of drug discovery process
- Knowledge and data management, extensive use of information research tools and databases
Associate Director, IP, Incentives & SOP Coordinator Chemistry Braine Braine-l'Alleud, Belgium
July 2009 --- February 2015
IP activities coordination
- Preparation of the technical and scientific information for the evaluation by IP department of chemical entity patentability and freedom of use, including novelty and originality searches.
- Organization, preparation and compilation of the technical and scientific documents necessary for patent application filing. Elaboration of general formula ensuring the best protection of compounds, preparation and review of the patent applications with IP department and scientists.
- Active involvement in the definition of patent strategies for different projects.
- Fostering interactions between IP department and scientists.
- In charge of the publication strategy for the department, the set-up and the follow-up of publications/posters/lectures planning in line with meeting attendance.
- Leadership role in the management of the internal review and follow up of UCB publications involving the department according to internal SOP (use of Datavision®).
Laboratory notebooks management
- Set-up and management, for all Research departments, of the application and the process allowing the electronic signature and witnessing of experimental work (PatentSafe®), independently of the Electronic Laboratory Notebook (ELN) source. Preparation and implementation of related SOPs and training.
- Active contribution to the chemistry ELN (Accelrys Symyx ELN) implementation and set-up, including related training.
- Organization and management of the transition from paper laboratory notebook system to the ELN for all Research departments in Belgium.
- Organization and management of paper laboratory notebook scanning and archiving for all Research departments in Belgium.
- In charge of the activities linked to Chemistry ELN and associated systems improvement.
- Project leader for the new chemical entities registration client.
- Participation to internal audits of laboratory notebooks.
Incentives Management (grants/funding of research activities)
- Coordination of activities and support to scientists in the preparation and filing of application forms for European and national funding programs.
- In charge of one Marie Curie European project and another one funded by Walloon Region.
IP Coordinator Chemical Research Braine-l'Alleud, Belgium
September 1998 --- July 2009
- Preparation and compilation of technical documentation for the evaluation by IP department of chemical entity patentability and freedom of use, or for patent application writing.
- Patent literature survey according to research projects and therapeutic area.
- Follow-up and analysis of originality searches.
- Set-up and management, for all research departments of a unique paper laboratory notebook system.
- Design and implementation of a system ensuring the follow-up and the internal review of the department publication projects.
- In charge of the coordination of activities between IP department and Chemical research department.
- Head of the Chemistry center of expertise in charge of providing end-users with high quality information and with advanced information research services, anticipating future information needs and identifying new information materials and sources to acquire (journals, databases).
Scientific Direction Scientist Braine-l'Alleud, Belgium
August 1995 --- September 1998
- Preparation with scientists of technical files allowing the patent application writing by IP department, including elaboration of general formulae.
- Set-up and follow-up of activities required by IP department for patent and IP rights defence.
- Management of custom synthesis agreements related to the radiolabeled compounds.
Student Researcher Lille, France
January 1994 --- January 1995
Putting an HPLC system into service (Waters Delta Prep 4000)
Student Internship Seclin, France
July 1990 --- July 1990
Industrial training. Analysis of products in fermentation
Student Internship Châteauroux, France
August 1989 --- August 1989
Comparative study of European carbonless papers.
Analytical thinkingAttention to detailCollaborationCoordinationCuriosityEfficiencyFlexibilityInterest in knowledgeIndependenceOrganizationProactivityWillingness to compromiseResponsibilitySelf-disciplineResult OrientedAdaptability
Quality Assurance (QA)Regulatory affairsRegulatory ComplianceRegulatory RequirementsUnderstanding of regulatory guidelines
Scientific writingEarly development stageDrug development processDrug substance developmentGood Laboratory Practice (GLP)GMPGood Publication Practice (GPP)Grant Preparationgrant writing and designICH GCP guidelinesKnowledge of the drug development processLaboratory ResearchMicrosoft OfficeNeuroscienceNew Drug Application (NDA)PatentsPharmaceutical IndustryPhases of clinical development (phase I to IV)Pre-clinical researchSOPTechnical reportsWriting Study Procedures and SOPsUnderstanding of regulatory guidelinesR&D
Skills and Expertise
Liaise with professionals in other divisions of the company as requiredLiaise with research team in order to accurately collect and record dataWrite papersDevelop training materialsFollow up training programsTrain StaffDevelop strong internal relationships with stakeholdersPrepare manuscriptInteract with regulatory stakeholdersWriting regulatory documentsCreate standard operating procedure (SOP)
Writing of technical & scientific documentationCoordination of intellectual property activitiesPublication management Create SOPsImplementation of SOPs and trainingsEuropean and national funding schemesProject coordinationproject planningAnalyzeassimilate and summarize informationinteraction with multiple stakeholdersCoordinationOrganise steering committeeDemonstrated initiativeflexibility and organizational abilitiesAbility to influence and convince in a non-hierarchical relationshipdrug discoveryKnowledge and data managementInformation research tools and databasesConduct literature searchesFamiliar with environmentalhealth and safety standards literature related to chemistryFamiliar with REACH RegulationRegulatory basic knowledge
CAPI 2003 (Certificat d’Animateur Propriété Intellectuelle) in Droit de la propriété intellectuelle, valorisation de la recherche from CAPI INPI in 2003
PhD in Organic and Macromolecular Chemistry from Université des Sciences et Technologies de Lille (Lille I) in 1995
Master 2 in Drug Design from Ecole Nationale Supérieure de Chimie de Lille in 1992
DEA in Organic and Macromolecular Chemistry from Université des Sciences et Technologies de Lille (Lille I) in 1991
Master Degree in Chemistry and Chemical Engineering (Ingénieur chimiste) in Chemistry from Ecole Nationale Supérieure de Chimie de Lille in 1991
Training and Certification
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual) – RAPS, on-line training, on-going since August 2016 in 2016 Training
Regulatory Affairs. Introduction to the regulation of medical products and health products (CULTURE IN VIVO asbl, Nivelles, Belgium, 1 day) in 2016 Training
Regulatory Affairs. Specific regulatory aspects of biologics (CULTURE IN VIVO asbl, Nivelles, Belgium, 1 day) in 2016 Training
Good manufacturing practice (GMP) (CEFOCHIM, Seneffe, Belgium) in 2015 Training
Good practice in pharmaceutical validation (CEFOCHIM, Seneffe, Belgium) in 2015 Training
Build and develop your leadership, internal training in 2012 Training
Open Innovation ((CEFOCHIM, Seneffe, Belgium) in 2010 Training
Knowledge management (CEFOCHIM, Seneffe, Belgium) in 2009 Training
Communicating and influencing effectively, internal training in 2008 Training
Project management, internal training in 2006 Training
Stratégie de dépôt de brevets et de valorisation des innovations (Comundi, Paris, France) in 2006 Training
Recherche, Innovation et Propriété Intellectuelle. Application aux secteurs de la chimie et des sciences de la vie (as an auditor, third-cycle courses, UCL, Belgium) in 1997 Training
Good laboratory practice (GLP) (CEFOCHIM, Seneffe, Belgium) in 2015 Certification