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Rédaction scientifique/ Medical writing

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Chef de projet affaires médicales - études cliniques/ Medical writer
Catégorie :

Rédaction scientifique/ Medical writing

Date de dernière mise à jour :

28 septembre 2016

Lieu :

Paris

CV :

Business Title: Medical Writer, PhD
Actual employer: Umanis (Sanofi France)
Country of Residence: France
Driving License: B

Educational History

12/2015 Sanofi Clinical Documentation Department, France - Medical Writer Training
02/2014 For Drug Consulting, France - CRA certificate
02/2012 University of Milan, Italy - PhD Molecular Medicine
10/2007 University of Bologna, Italy - Master Degree Pharmaceutical Biotechonology
02/2005 University of Bologna, Italy - Bachelor Degree Pharmaceutical Biotechonology

Employment History
Date of Employment: 12/2015 – on going
Name of Employer: UMANIS
Job Title: CONTRACTOR MEDICAL WRITER AT SANOFI FRANCE
Key Responsibilities: Provide clinical document support and advanced scientific writing expertise to the clinical team to generate high quality submission-ready documents, specifically for Developmental Safety Update Reports (DSUR) and Investigator Brochures (IBs). Ensure accurate and timely completion/delivery of documents and information for clinical submissions. Manage the document review process. Participate in project team meetings to provide input regarding deliverables, timelines, and processes.

Date of Employment: 05/2014 – 11/2015
Name of Employer: QUINTILES
Job Title: CRA FOR AMGEN
Key Responsibilities: Conduct evaluation, initiation, monitoring and close-out visits for assigned protocols and site. Evaluate the quality and integrity of study practices related to the proper conduct of the protocol and adherence to GCP and applicable regulatory requirements. Escalate quality issues, train and provide assistance to site staff. Create and maintain appropriate documentation regarding site management and monitoring. Write and review communication with investigators, international and local study managers, follow-up letters, action plans. Participate in protocol-related meetings and collaborate with study team.

Date of Employment: 03/2012 - 09/2013
Name of Employer: INSERM
Job Title: POST-DOCTORAL ASSOCIATE RESEARCHER
Key Responsibilities: Lead a project and conduct research activities in a cardiogenesis and stem cell laboratory. Work in tight collaboration with a biotech start-up. Elaborate strategies to develop scientific concepts. Perform scientific writing and oral presentations. Supervise trainees' activities.

Date of Employment:
04/2008 - 02/2012
Name of Employer: CNR/I.R.C.C.S Multimedica
Job Title: PHD ASSOCIATE RESEARCHER
Key Responsibilities: Lead a project and conduct research in a cardiovascular research laboratory. Perform scientific writing and oral presentations. Supervise trainees' activities.

Clinical Trial Experience
Study Phase: Phase 1 - 2 – 3 - 4.
Therapeutic area: Breast cancer, Asthma, Chron's disease, Psoriasis, Cardiovascular Disease, Non-Hodgkins Lymphoma, Osteoporosis, Pulmonary fibrosis, Diabetes, Fabry disease, Advanced malignant solid tumors, Myelomas, etc.

Language (s): Speaking - Reading - Writing
Italian: Fluent - Fluent - Fluent
English: Fluent - Fluent - Fluent
French: Fluent - Fluent - Fluent
Portuguese: Business Level - Fluent - Business Level

Remarques :

Remarkable leadership and management skills.

Strong interest in working within or in collaboration with medical affairs and clinical operations units.

Able to provide recommendations from previous employers and trainers in clinical research.

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