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Rédaction scientifique/ Medical writing

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rédactrice médicale
Catégorie :

Rédaction scientifique/ Medical writing

Date de dernière mise à jour :

23 août 2012

Lieu :

Dijon (home based)

CV :

MAIN EXPERIENCE AND CAREER HISTORY

01/05/2009 to present : Medical Writer / Medical Writing Coordinator
Laboratoires FOURNIER (Abbott), Dijon

Write phase III and IV Clinical Study Reports, subject narratives in cardiometabolic and gastroenterology therapeutic areas (mixed dyslipidemia, hypertriglyceridemia, hypertension, portalsystemic encephalopathy and cystic fibrosis).
Write updates for Investigator Brochures (all parts), eCTD clinical sections 2.7.3, 2.7.4 and 2.5 in cardiometabolic and neuroscience therapeutic areas.
Coordinator of the production of phase I to IV Clinical Study Reports and protocols if outsourced to Contract Research Organizations. Preferential contact for the CRO Medical writer.
Responsible for an efficient production planning, review and internal approval process in order to make available up to date clinical and regulatory supportive documents in appropriate format and quality.
Ensure quality control and standardization across study reports and other clinical documents.
Supervision of the preparation of report’s appendices and submission readiness requirements.
Provide support and input to development and maintenance of global procedures and instruction guidelines.
Review of Statistical Analysis Plans.
Participation in the review of the CT.gov study results registration.

Therapeutic areas: cardiometabolic, neuroscience, gastroenterology, hormones.

07/08/2006 to 01/05/2009 : Clinical Trial Manager
Laboratoires FOURNIER (Solvay Pharma), Dijon
Coordinator of all partners activities for an international phase III study since initiated ; involvement in all strategic decisions regarding recruitment, management of all logistical issues, participation in the writing of clinical study outlines, clinical study report and guidelines for investigators, involvement in study drugs supplying, data management, review of regulatory documents, management of insurance and financial issues, co-monitorings abroad, review of monitoring trip reports and all related study documents.

Therapeutic areas and pathologies : cardiology ; mixed dyslipidemia, hypertriglyceridemia .

01/11/2004 to 31/O5/2005 : Project Manager Assistant (Lead Clinical Research Associate)
ICTA, Dijon
Supporting two Project Managers for the management of phase III clinical trials ; management of 3 teams of 10 CRAs, centralisation, review and finalisation of all SAE reports for client, centralisation of all waiver requests and submission to client, management of all study drugs issues, preferential client contact, management of logistical issues, coding of CRF data.

Therapeutic areas and pathologies : cardiology ; hypercholesterolemia, hypertension, nephrology ; worsening of renal function.


01/03/1999 to 31/01/2004 : Clinical Research Associate
COVANCE, Rueil Malmaison
Local project coordinator ; initiation, monitoring, and management of phases II, III, IV clinical trials, feasibility assesments, preparation of EC submissions and notification to regulatory authorities.
Training of new CRAs for the preparation of pre-studies visits, initiation visits, and monitoring visits.
Therapeutic areas and pathologies : cardiology; hypercholesterolemia, urology ; urinary incontinence, erectile dysfunction, dermatology ; alopecia, vascular surgery ; peripheral arterial disease.

03/12/97 to 01/03/1999 : Clinical Studies Assistant
COVANCE, Rueil Malmaison
Phase II and III clinical trials : assistant of the local project coordinator.
Therapeutic areas : gastroenterology, oncology, endocrinology.

Oncology phase III trial : assistant of the project manager.

LANGUAGES

French : mother tongue.
English : written and verbal ; worked in international team.
German : notions.


QUALIFICATIONS

1996 Superior diploma specialised : « Health law ». University of Paris XI.
1995 Master Degree of physiology. University in Dijon.

TRAINING RECEIVED

2012 Completed the Foundation EMWA Professional Development Programme in Medical Writing in drug development area (foundation).

2011 Completed the Foundation EMWA Professional Development Programme in Medical Writing in multidisciplinary area.

03/06/96 to 31/07/96 French Medicine Agency, Paris : «The regulatory of laboratory reagents in France and in Europe ».

20/06/95 to 28/07/95 National Institute in Applied Research, Dijon : «The effects of food microconstituents on cancer».



OTHERS

ISIWriter, Documentum, MS Project.
Driving licence.

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