WORK EXPERIENCE
• March, 2006 - Present ASCOPHARM (Contract Research Organization - France):
• Senior Project Manager (outsourced since March, 2006 in the Medical Affairs Department of an International Pharmaceutical Company): Management of worldwide clinical studies and registries (Cardiology, Allergology, Metabolism, Pain, Oncology)
=> Team Management: an average of 4 people per country and 10 countries per study
=> Budget Management: up to 3 million of Euros
=> # sites / # patients: up to ~ 1.000 sites / more than 12.000 patients
• Responsibilities:
o Coordinate all Study Team Members/Partners activities
o Organize meetings as appropriate (project team, monitors, experts)
o Monthly report to Head of Clinical Operations
o Manage study budget (forecast and tracking)
o Selection of CROs/Vendors in collaboration with Purchasing
o Write protocol, amendment and informed consent in collaboration with the Medical Manager/Director and ad-hoc Team Members
o Develop and/or validate other study documents
o Coordinate and follow-up CROs/Vendors activities
o Validation of CRO/Vendors/Experts contracts in collaboration with Legal
o Affiliates’ training to study specificities
o Maintain a close collaboration with Affiliates to optimize study progress
o Coordination of Data Management and Statistical processes
o Coordination of Study Report writing and validation
o Ensure proper study documentation is maintained and archived
• Ad hoc activities: Mentoring of junior Project Managers, contribute to process developments and/or improvements (participation to Standard Operating Procedures writing, development of an Excel tool for the Affiliates to help them evaluate per involved functions and study periods, the number of Full Time Equivalent needed to manage a study)

• July, 1999 - February 2006: FOVEA (Contract Research Organization - France):
• January, 2001 - February 2006: Sales Manager of Medical Department
o Drive company business development
o Finalization and presentations of proposals to Pharmaceutical Companies
o Contracts review
• January, 2001 - February 2006: Project Manager
o Conception and development of all relevant study documentation (protocol, Case Report Form…)
o Regulatory management
o Implementation and follow-up of projects
o Budget management
o CRA management
o Coordination of Biometry activities (Data Management, statistical analysis)
o Clinical Study Report drafting (ICH, statistical)
=> Team Management: 4 people per study on average
=> Budget Management: 150 k€ per study on average
=> # sites / # patients: ~ 60 sites / ~ 300 patients per study on average
• Cardiology:
o Phases III and IV studies (Hypertension)
o Post-Marketing studies (Coronary risk, Atherosclerosis)
• Dermatology:
o Phase I study (Psoriasis)
o Phase IV study (Chronic Idiopathic Urticaria)
• Hepato-Gastro-Enterology:
o Registry (Hepatitis C et Toxicology)
o Retrospective registry (Gastro-oesophageal reflux)
• Oncology:
o Phase II study (Breast cancer) – e-CRF
o Registries (Gynecological and urinary tumors, Prostate tumor)
o Retrospective registry (Prostate cancer)
• Other therapeutic areas:
o Neurology: Retrospective registry (Friedreich’s ataxia)
o Vaccine study: Phase III European study – e-CRF
• Other mission: External Consultant for an International Pharmaceutical Company: Develop company standard of Case Report Form with specific modules connected to the therapeutic areas

• July, 1999 - December, 2000: Clinical Research Associate
o Feasibility study
o Investigators pre-screening and screening
o Implementation (single and collective)
o Follow-up and closed-up visits
• Cardiology: Phase III studies (Hypertension)
• Dermatology: Phase III study (Facial herpes)
• Oncology: Phase IV study (Breast cancer)

EDUCATION AND TRAINING
• 2008: English lessons by phone (20 hrs) - goFluent
• 1999: Clinical Research Associate Training – CLINACT (France)
• 1998: Master of Science in Cellular Biology and Animal Physiology, Genetic and Biostatistics majors (University of Paris VI - France)
• 1996 / 1997: 1st year of Medical school at Broussais - Hôtel Dieu hospital (University of Paris VI - France)
• 1995: Batchelor of Science in Cellular Biology and Animal Physiology – University of Paris VI (France)

LANGUAGES AND SKILLS
• English: Fluent
• Russian: Basic
• Software: Microsoft Windows, Word, Excel, Power Point, Access, Outlook

HOBBIES
• Choral song: Musical comedies with public representations
• Sports: Scuba diving, walking, roller
• Travels: Russia, United Kingdoms, Italy, Spain, Estonia, Guadeloupe, Egypt, Turkey, Morocco, Mexico, Malaysia, Indonesia, Netherlands, Argentina, Lebanon
• Other: Violin, reading


COVER LETTER

After more than 10 years of experience in the Pharmaceutical Industry, of which I spent the last 9 years as Project Manager in both CRO and International Pharmaceutical Companies, I am today at a point of my career where I wish to take on new challenges. I would like to take a new direction and join a company that offers a large variety of business areas and that presents strong and attractive evolution opportunities.
I have dealt with a wide range of business roles and projects which have lead me to develop many skills in business and team management. I have strong interpersonal skills. I am an accomplished Project Manager with a broad experience in clinical research, acquainted with French and International clinical studies or registries that arise in International Clinical Companies.
I consider myself outgoing, with plenty of enthusiasm, flexible, open minded, and team leader material. I remain available to comment and provide further details on my professional project. Please do not hesitate to contact me.

Beatrice Elziere - Saint Vil
Cellular: + 33 (0) 6 72 07 13 52
e-mail : belziere@gmail.com

Actuellement interne en pharmacie spécialisée, j’ai eu l'occasion de gérer entièrement une étude observationnelle de la rédaction du protocole à la valorisation des résultats, présentés oralement lors d’un congrès international.

Titulaire d'un Master II pharmaco-épidémiologie, je justifie d'une expérience globale de 4 ans dont une en industrie pharmaceutique.

Je souhaite mettre à profit mon sens de l’organisation et mon souci de la qualité au sein d'une équipe ambitieuse et stimulante.

Sachez que je suis mobile géographiquement.

Adresse mail : gaeldes7@free.fr
téléphone : 0667269509

Je travaille depuis plus d’un an à un poste d’engineering pour la société Janssen-Cilag (Groupe Johnson & Johnson). Mon rôle est de « manager » des projets d’acquisition d’équipements afin d’optimiser les capacités de production de notre site industriel et de répondre aux exigences réglementaires. Ma principale mission consiste à piloter dans son intégralité un projet d’envergure, de l’analyse des besoins clients à la qualification des nouveaux équipements (implantation de technologies de traçabilité en réponse à une directive de l’AFSSAPS). La rédaction d’un cahier des charges, le management d’une équipe projet, la prospection de fournisseurs et, d’une manière plus générale, le pilotage du projet sont sous ma responsabilité.

Au cours de mes diverses missions, j’ai pu mettre à profit mes qualités d’efficience, de prise de recul et mon goût pour les relations humaines, qu’elles soient dans le cadre de management d’équipe ou de consultation de fournisseurs.

Ma récente formation et mon expérience me permettent, aujourd’hui, de réunir un ensemble de compétences que je serais ravi de mettre au service d'un nouveau challenge professionnel

Adresse mail : jeremypicard77@yahoo.fr
téléphone : 0607946685

MANAGER COMMERCIAL
18 ans d’industrie pharmaceutique
8 ans de Direction d’équipe commerciale
Master 2 d’Administration des Entreprises (2009)

Compétences Professionnelles : Diriger et développer une équipe commerciale dans l’industrie de Santé humaine ou animale, les dispositifs ou le matériel médical, la distribution pharmaceutique, l’agroalimentaire, la nutrition…

CDI, CDD, missions de transition acceptés
Mobile France (Ouest, Sud-Ouest, Nord et IDF)

http://www.viadeo.com/fr/profile/vincent.berthelot5
mobile : 0645831535
fixe : 0231852947

EXPERIENCES PROFESSIONNELLES

Nov 2009 – Avril 2010

Développement pharmaceutique, Sanofi-Aventis, Vitry-sur-Seine (94)
Développement d’un agent anticancéreux : étude de faisabilité d’une formulation liposomale (méthode de Bangham, Dissolution directe et Injection directe) ; étude de faisabilité d’une formulation de nanocristaux (screening de stabilisants, caractérisation physico-chimique, étude des paramètres de broyabilité) ; développement d’une formulation à base de Captisol® (étude de stabilité).
Développement d’un antipaludéen (étude de conservateurs microbiologiques).
Screening de formulations en Support Discovery (études précliniques).


Mars – Août 2008

Développement pharmaceutique, Sanofi-Aventis, Vitry-sur-Seine (94), Stage R&D
Mise en place d’une méthodologie destinée au développement de formulations micellaires pour la voie parentérale (paramètres de Hoy, design-space) ; optimisation de cette formulation (construction de diagrammes de phase et formulation de microémulsions) et étude de stabilités physico-chimiques (recristallisation en poche).


Mai – Juillet 2007

Chargée d’études physico-chimiques, Ipsen Pharma (Barcelone), Stage Ingénieur Etudes des propriétés physico-chimiques d’un peptide dérivé d’une hormone naturelle, et de ses agonistes thérapeutiques (caractérisation de la morphologie des structures formées, étude de la cinétique et du mécanisme de dissolution).


Juin – Juillet 2006

Technicienne d’analyse, Sandoz, Aubervilliers (93), Stage
Analyse d’une matière première et suivi de stabilités d’un produit fini selon la Pharmacopée européenne. Etude d’un dossier d’AMM.


Maîtrise des technologies suivantes :

Microscopie électronique en transmission, Microscopie optique à lumière polarisée, DQEL (Nanosizer), Zetasizer, Spectrophotométrie UV-visible, Calorimétrie (DSC), HPLC, CPG, Karl Fisher, Viscosimétrie capillaire, Densimétrie, Mesure d’osmolalité, Tensiomètre à bulle, NanoMill®, Crystal16®, Granulométrie laser, Broyeur Planétaire


Divers 2008 - 2009
Street marketing / Hôtesse d’accueil-secrétaire d’un centre d’affaires


FORMATION


2005 - 2008

Diplôme d’Ingénieur chimiste à l’ENSCR (Ecole Nationale Supérieure de Chimie de Rennes), Majeure chimie et technologies pour le vivant
Options molécules biologiques et physico-chimie, analyse et formulation


2003 – 2005

Classes Préparatoires aux Grandes Ecoles, filière physique/chimie, Lycée Carnot Paris


Juin 2003

Baccalauréat série S, option physique/chimie, Académie de Paris


COMPETENCES LINGUISTIQUES ET INFORMATIQUES


Espagnol
Bilingue (Titulaire du certificat de langue et culture espagnoles, obtenu en 2002)

Anglais
Courant (Toeic : 765 points)


Informatique :

Word, Excel, PowerPoint, Internet Explorer, Outlook Express, Lotus Note 6.5, NVU, Gimp, Spot, Sigma Plot, ProSim Ternary Diagram, Fortran, Maple V


LOISIRS ET CENTRES D’INTERÊT

- Multiples séjours en Espagne
- Titulaire du brevet national de premiers secours (BNPS)

karinegonzalez@yahoo.fr

Fort d'une expérience de 9 ans en recherche pré-clinique (Toxicologie, Neuropsychopharmacologie, Maladie Métabolique) et 4 ans en Data management, je souhaite intégrer une nouvelle équipe en tant que Project Manager afin d'y apporter mes connaissances et mon Dynamisme. Doué d'écoute active, de rigueur et d'un bon sens du relationnel et du management je saurais apporter à mes collaborateurs toute mon expérience concernant la mise en place et la gestion des études cliniques, ainsi que mon aide sur l'application des SOP et des MOP nécessaires au bon déroulement des études.

Jimmy.mullot@club-internet.fr (e-mail personnel)
Jimmy.mullot@fr.netgrs.com (e-mail professionnel)
Tel professionnel : 01 55 72 77 54

Double formation, pharmacien + mastère Marketing HEC.

Actuellement chez JANSSEN-CILAG, Johnson & Johnson, Issy les Moulineaux
Chef de produit junior Douleur : Durogesic®, Effentora®
• Stratégie d’un médicament génériqué et d’un médicament en lancement
• Réalisation des outils de campagne
• Contact direct avec diverses agences et éditeurs
• Présentation des campagnes lors des séminaires
• Formation des délégués médicaux
• Collaboration avec le médical, les affaires réglementaires, les ventes.
• Suivi et analyse des données GERS
• Représentation du laboratoire lors de congrès : SFAP, SFAR,SFETD
=> Marketing opérationnel, réseaux ville et hôpital

Mlle Texte Clémence
clemence.texte@hotmail.fr

A 31 ans je cherche à m’installer sur la région Languedoc-Roussillon où je possède déjà une adresse. Je souhaite fortement occuper un poste de commercial valorisant mes compétences professionnelles dans le monde médical, au sein d’un laboratoire reconnu dans son domaine d’activités pour m’y investir durablement et sereinement.

Depuis Mars 2008
Délégué commercial en contactologie, laboratoire COOPERVISION auprès des opticiens et ophtalmologistes sur 10 puis 6 départements (10, 18, 21, 25, 39, 52, 58, 71, 89, 90).
Missions : - présenter une gamme de lentilles sphériques et techniques auprès des ophtalmologistes du secteur afin d’orienter leurs prescriptions sur celle-ci, mises à disposition et réassort des boites de lentilles d’échantillons pour essais, suivi des statistiques et visites régulières
- même travail auprès des opticiens adaptateurs de lentilles, et négociations sur les quantités et remises effectuées sur les stocks achetés par ces derniers et destinés à la vente sous forme de partenariats, suivi des statistiques et visites régulières
- préparation et animation de soirées promotionnelles sur les nouvelles lentilles où sont conviés les ophtalmologistes et/ou les opticiens d’une zone définie, ainsi que des journées portes ouvertes dans les points de ventes (5 à 10 manifestations par an).

Grégory HEYMANN
8 Place Elsa Triolet / 1 Rue Pierre et Marie Curie
21600 Longvic. 34800 Clermont-l’Hérault.
06 62 63 02 49
E-mail: greg.hey@hotmail.fr

PROFESSIONAL EXPERIENCE


• Since January 2010: Chief Executive Officer of ORVACS (AIDS Vaccine Research Non-for-Profit Organization) – La Pitié-Salpêtrière Hospital (Paris) concomitantly to the Project Director role
o Budget and finances coordination
o Partnership contracts negotiation
o Additional grants research
o Reporting to the funders: definition of programs, annual and study reports
o Organization of administration boards and assemblies (since June 2007)
o Development of the institutional collaborations: University Pierre et Marie Curie (UPMC - Paris VI) / INSERM, Federative Institute for Research (IFR 113) “Cancer, Infection, Immunity”
o Participation to the ANRS Clinical Research Days 2009 & 2010

• Since June 2007: Project Director in ORVACS

1. Since June 2007:
 Coordination of the ORVACS worldwide network: clinicians, immunologists, virologists, academic and industrial partners
 Organization of the annual Scientific Advisory Board meetings
 SOPs and documents templates writing

2. From June 2007 to December 2007: MANON Program (anti-HIV therapeutic vaccination) close-out
 Final study report writing and submission to the German Competent Authorities
 Internal central file audit
 Transcutaneous vaccination license application writing

3. Since December 2009: Clinical Trials Specialist for the CUTHIVAC Program (ORVACS/INSERM)
 Definition of the clinical trials design for the evaluation of anti-HIV therapeutic vaccines via the transcutaneous pathway
 Identification of the vaccine candidates and negotiations with producers (biotechnology companies)
 Compilation of the grants request for the European Commission

4. Since January 2008: The ERAMUNE Program (therapeutic intensification plus immunomodulation towards HIV eradication)
 Definition of the main program rationale and objectives
 Definition of global and per-study budgets
 Coordination of the ERAMUNE Steering Committee
 Organization of the program-dedicated meetings (Paris, Montreal, San Francisco, Vienna)
 Negotiation of the contracts with industrial partners for study drugs provision and grants provision
 Development, management and coordination of two local preliminary physiopathologic studies under French regulation (non-pharmaceutical product evaluation or equivalent)
 Step-by-step clinical trials’ protocols development and writing
 Identification of the service providers and contracts negotiation: CRO, Central Pharmacy Service, Central Laboratories, Pharmacovigilance Department, Freight Operator, Data Management and Statistics Unit
 Selection of the participating sites and laboratories (in Europe and USA)
 Development of the patient information letter (French and English versions) for the European study
 Preparation of the main submission package for Europe and submissions to the French Competent Authorities
 Coordination of the IND submission in the US together with the local CRO
 Development of the monitoring plan
 Development of the training material for study sites personnel and sponsor representatives

5. Since October 2008: Quality Assurance Manager in CREPATS (AIDS Pharmaceutical Therapy Non-for-Profit Organization affiliated to ORVACS) – La Pitié-Salpêtrière (Paris) – The RADAR Study
 Member of the Steering Committee
 Study protocol review and validation
 Negotiation of the contract with the industrial partner for study drug provision and funds provision
 Recruitment of the CRAs allocated to the study
 Preparation and submission of the regulatory package to the French Competent Authorities
 Review and validation of the monitoring visits reports
 Central File quality maintenance

6. From October 2007 to September 2008: Regulatory Affairs Consultant for the THERAVAC-03 Study (ORVACS/INSERM/EuroVacc Foundation)
 Preparation of TheraVac-03 study submission process for compliance with ICH-GCP, European and EU members regulations
 Review of study-related documents (patient information letter, protocol, CRF, Investigator Brochure, …)
7. Since September 2008: Consultant associated to the Pharmaceutical Sciences Department of the University of Caen for the University Degree “Research and Pharmaceutical Development of Medicaments”

• From January to June 2007: Head of Clinical Studies in the International Research Institute Servier (Courbevoie) – 4 months mission for an international phase III cardiology study (48 participating countries, 650 centers, 18000 patients)
o Coordinator for 5 participating countries
o Coordination of the pharmacovigilance review board
o Coordination of the study material network (laptops, ECG machines, HSL phone lines)

• From September to December 2006: Clinical Team Leader 2 in Quintiles France (Levallois-Perret) for an international phase II oncology study (colorectal cancer, 12 countries in Europe and Canada, 48 centers, 210 patients)
o Coordination of the European and Canadian Clinical Teams
o Regular study status reporting to the Project Manager
o Support for CRAs during company and sponsor audits, preparation of Corrective Action Plans
o Preparation of an internal Trial Master File audit, elaboration of a Preventive Action Plan
o Management of resources allocated to the project

• From January 2006 to September 2006: Regional Coordinator / Clinical Lead in PAREXEL International (Vilnius) for an international phase III study (management of pain for patients undergoing haemodialysis, 13 countries in Europe, 70 centers, 400 patients)

• From September 2005 to January 2006: Senior Clinical Research Associate in PAREXEL International (Vilnius) for an international phase III cardiology study (15 participating countries, 5 centers in Lithuania for 70 patients)

• March 2004 – September 2005: Clinical Research Associate in PAREXEL International (Paris):
o International phase III oncology study (B-Cell Chronic Lymphocytic Leukemia)
o International phase III cardiology study (acute myocardial infarction)
o International phase II/III oncology study (gastro-intestinal and ovarian cancer)
o International phase IIIb study for the treatment of post-menopausal osteoporosis
o International phase III study for the treatment of Autosomic Polycystic Kidney Disease (ADPKD)

• October 2003 – February 2004: Clinical Research Associate in CHILTERN International, France – Miscellaneous tasks from feasibility studies to site close-out visits for an oncology study

• July 2003 – October 2003: Clinical Research Associate in Biologie & Industrie (CRO) , Montreuil, France – Out-placement in Omnicare Clinical Research for an international phase III trial in insomnia

• November 2002 – July 2003: Trainee Clinical Research Associate in the FNCLCC (French federation of medical centers against cancer), Paris
o European multicenter, randomized, opened phase III study in the treatment of non-metastatic breast cancer with lymph nodes invasion (2600 patients, 105 centers in France and Belgium)
o Multicenter, randomized, phase III study in the treatment of recurring breast cancer
o Opened, randomized, multicenter phase III study in the treatment of metastatic breast cancer
o Two multicenter phase II studies in the treatment of non-small and small cell lung cancer :
o Participation to the preparation of the regulatory authorities audit

• April 2002 – July 2002: Temporary Teacher of Biology and Life Sciences in school preparing students aged 15-18 for the baccalaureate and in secondary school

• July 2000 – September 2001: Trainee Researcher for the Master in Neurosciences grade. Neurofunctional Imaging Group, UMR 6095 CNRS / CEA / Universities of Caen and Paris 5. Directors: Pr Bernard Mazoyer, Dr Christophe Tzourio.
 Relations between the apolipoprotein E genotype and variations of the cerebral anatomy in healthy subjects aged between 55 and 65 years using the EVA national database (1500 subjects, 833 MRIs)

PROFESSIONAL TRAINING

• Since June 2007: Several trainings in HIV, infectious diseases pathogenesis and physiopathology, immunology and virology (Hepatitis B and C, CMV infection, opportunistic diseases) – University Pierre et Marie Curie (UPMC), INSERM, IFR 113 (Federative Research Institute – “Immunity, Cancer, Infection”), European AIDS Clinical Society (EACS)

• Since June 2007: Member of the Committee for Research in Immunology and Virology – University Pierre et Marie Curie (UPMC), Assistance Publique – Hôpitaux de Paris (APHP)

• October 2006: Internal QUINTILES training for the Implementation of the European Directive and its consequences on daily practice

• April 2006: Internal PAREXEL training for Communication and Negotiation with Sponsors and Third Parties (for Project Management positions)

• March 2006: Internal PAREXEL training for the Management of Cultural Differences within a professional environment (for Project Management positions)

• Since September 2005: Internal PAREXEL training for Clinical Trial Coordination and Management (for Clinical Lead position)

• September 2002 – November 2002: Master’s Degree in Pharmaceutical Development and Clinical Research – Pharmaceutical Sciences Unit, University of Caen

• September 2001: Master’s Degree in Neurosciences and Neuroimaging – Universities of Caen and Rouen (France)

Languages:
 French: native language
 English: Good working knowledge both written and oral. Frequent practice of the scientific and medical language. Daily practice in the private life
 Lithuanian: read and written, diploma obtained in Vilnius University in December 2005.
 Spanish: Good working knowledge both written and oral.

Computing and Information Technologies:
 Significant practical experience in Windows environments (9.x, NT, 2000, XP)
 Good working knowledge of UNIX environments (Sun Solaris, SGI Irix, BSD, Linux)
 Frequent use of office automation software under Windows environments (Microsft Office, Corel WordPerfect) and under UNIX environments (Sun StarOffice)
 Lotus Notes (databases and mailbox tools)
 Good working knowledge of video and image processing (Photoshop, Paint Shop Pro) and image analysis (SPM99, VoxeLine).
 Computer languages : (X)HTML, JavaScript, R (statistical data processing)


FURTHER INFORMATION

• 32 years old
• French nationality
• National and international mobility
• Leisure:
 Literature (novels and history)
 European medieval and Renaissance history
 Archeology (amateur)
 Art-house cinema
 Sailing and nautism

François LECARDONNEL, M.Sc.
14, rue de Strasbourg
92600 ASNIERES-SUR-SEINE
France
Phone : +33 9 54 35 02 62
Mobile : +33 6 81 63 24 75
francois.lecardonnel@yahoo.fr
francois.lecardonnel@blackberry.orange.fr

I am looking for a position of Marketing/Communication Manager in the pharmaceutical industry ( included medical devices) or in the diagnostic industry.( preference for an international position).
Pharmacist + MBA ( CESMA/CRANDFIELD), I have an experience of 19 years in Pharma and Diagnostics. I have worked internationaly many times in my career.
Very good knowledge of marketing ( strategic and operational), of communication and events management.
Management of small teams and capacity to lead projects and motivate teams around complex issues.
Mobility in Europe .

Dr. Nathalie PECHOUX
email: pechouxnathalie@yahoo.fr
Mobile: +33(0)661466422