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Rédaction scientifique/ Medical writing

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Rédacteur médical
Catégorie :

Rédaction scientifique/ Medical writing

Date de dernière mise à jour :

22 janvier 2014

Lieu :

CV :

More than 30-year clinical research experience (clinical trial project management, medical marketing, medical writing).

Skills in Word, Powerpoint, Excel.

From July 2007
Freelance Medical Writer – Bordeaux
• clinical study protocols,
• patient information leaflets/informed consent forms,
• investigator brochures,
• ICH clinical study reports,
• literature reviews,
• regulatory affairs documents (clinical expert reports in CTD format, query management in Mutual Recognition Procedure, Summaries of Product Characteristics, scientific overviews, technical dossier for Commission de Transparence, “medico-technical dossier” for medical devices),
• publications.

Therapeutic areas: cardiology (hypertension), diabetes, gynaecology (HRT/menopause/osteoporosis, genital infections), gastro-enterology (irritable bowel syndrome), medical devices (ventricular assist devices, endovascular stent grafts, endocanalar stents, patch angioplasty, prosthetic materials for hernia repair, dermal fillers, leg compression devices/dressings in chronic venous insufficiency, adaptative servoventilation in Cheyne-Stokes respiration, oral appliances for sleep disorders), neurology (chronic pain, epilepsy), ophthalmology (glaucoma, age-related macular degeneration), rheumatology (osteoarthritis), urology/andrology (male hypogonadism, erectile dysfunction, prostate cancer, benign prostate hyperplasia, metastatic renal cell carcinoma).

November 2003 – July 2007
Medical Project Manager / Institut de Recherche Pierre Fabre (Ramonville)

• Discuss clinical development plans, design clinical studies, contact investigators, write protocols and investigator brochures, organise investigator meetings, support CRAs and clinical study coordinators for medical issues throughout clinical studies, valid data base coding, write clinical study reports and clinical sections of regulatory documents in accordance with ICH guidelines and internal SOPs.
• Provide medical expertise to regulatory scientists for preparation of regulatory documents.
• Interface with Drug Safety Department.
• Provide medical expertise to marketing colleagues for preparation of abstracts, posters, and manuscripts resulting in publication of clinical trial results.
• Monitor relevant global scientific/medical literature.
• Therapeutic areas: male hypogonadism (european clinical development of a testosterone transdermal system : phases II and III), vertigo (european clinical development of an antivertigo drug : phases I, II and III), erectile dysfunction (phases I).

September 2001 - November 2003
General Manager BIOMIT France SAS (french subsidiary of a swiss CRO - BIOMIT Basle)
• Responsible for local administrative/financial management ; coordination of project managers and CRAs for Phase I-II-III clinical trials over France; submission to local Health Authorities and Ethics Committees; medical writing (protocols, clinical study reports, experts reports on clinical documentation, abstracts, manuscripts).
• Therapeutic areas : urology (BPH), dermatology (topical dermocorticoids, drugs for alopecia, seborrheic dermatitis), rheumatology (rheumatoid arthritis), cardiology (hypertension), ENT (vertigo).

August 1998 - August 2001
Clinical Operations Director / ITEC Services (CRO - Bordeaux)
• Coordination of project managers and CRAs for Phase I-II-III clinical trials carried out in France or Spain.
• Medical writing (protocols, clinical study reports, experts reports on clinical documentation, manuscripts for publications, abstracts, monographs).
• Therapeutic areas : urology (prostate cancer, BPH), gynaecology (HRT, metrorragia, medical devices for surgery), neurology (cognitive/memory disorders in the elderly).

February 1995 - July 1998
International Medical Marketing Manager / Pierre Fabre Médicament (Castres)
• Development of opinion leader relations to support product credibility.
• Interaction with external experts, clinical investigators, alliance partners, and affiliates to plan, initiate, and conduct world-wide clinical trials (mainly Phase IV).
• Medical assistance to CRAs in clinical trial monitoring.
• Medical writing (protocols, clinical study reports, experts reports on clinical documentation, manuscripts for publications, abstracts, monographs).
• Collaboration in marketing strategy development and lauching activities.
• Scientific/Medical support to Area Marketing Project Managers for the elaboration of promotional material.
• Participation in sales forces training.
• Participation to congresses, symposia.
• Therapeutic areas : urology (BPH), rheumatology (osteoarthritis, postmenopausal osteoporosis), gynaecology (anemia, venous insufficiency).

August 1992 - February 1995
Clinical Trial Director (Internal Medicine Department) / Pierre Fabre Médicament (Labège)
• Coordination of project managers and CRAs for Phase II-III clinical trials..
• Medical writing (protocols, CRFs, clinical study reports, experts reports on clinical documentation).
• Therapeutic areas : gynaecology (HRT), angiology (venous insufficiency), nephrology (peritoneal dialysis), dermatology (seborrheic dermatitis, cutaneous mycosis), rheumatology (osteoarthritis).

January 1980 - July 1992
Medical Project Manager / Laboratoires SARGET-ASTA MEDICA (Bordeaux)
• Contacts with investigators, initiation and monitoring of clinical trials, medical writing (protocols, CRFs, clinical study reports, publications) for Phase I-II-III studies for various drugs : a lipid-lowering agent, an antiarrhythmic agent, a NSAI drug, a long-acting theophylline, a iodine antiseptic (colic surgery, extensive burn wounds, stump amputation and elg ulcer healing), a cerebral vasodilator (« psycho-behavioural disorders of the elderly), an alphablocking agent (erectile dysfunction, urinary bladder sphincter disorders).

October 1997 - December 1980
Emergency Physician at SAMU 33 (Emergency Medical Assistance Service), Teaching Hospital, Bordeaux.

November 1996 : 3° Cycle Doctoral Thesis (PhD) at Montpellier I « Intérêt d’un -bloquant, le moxisylyte, en chirurgie urologique : étude pharmacocinétique et pharmacodynamique. »

January 1992 : DEA (post-graduate diploma) « Interface Chimie-Biologie : Systèmes moléculaires à visée thérapeutique (Pr Chapat - Montpellier I University) »

June 1981 : CES (one-year post-graduate diploma) in « Statistiques for Biology », Human Biology Cycle , Bordeaux II University

May 1981 : CESAM – STAM (diploma in Biomedical Statistics) at Pierre et Marie Curie University, Paris VI

June 1980 : CES (one-year post-graduate diploma) in « Pharmacologie Spéciale Approfondie », Human Biology Cycle, Bordeaux II University

October 1978 : Doctor of Medicine, Bordeaux II University

July 1971 : Baccalaureate D with B+ (A level equivalent specialized in Life Sciences)

French : native fluency
Anglais :good skills, both written and oral

Gardening, cooking, swimming pool, reading

References available upon request

Remarques :

Rédacteur médical en "free-lance" depuis 2007 je suis intéressée par un poste salarié dans un cadre "home based" (avec déplacements réguliers si nécessaires).

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