Basel, Basel, Switzerland
Write clinical documents for pre-submission communications with Health Authorities (briefing book), the submission (CTD: CO, SCS, SCE, SCP, registration CSR etc.) and post-submission (answer to the Health Authorities: FDA, EMA, Swissmedic). Program writer and lead writer, coach younger writers, write/revise templates. Doctor in biology (PhD, in France), I started my career as researcher in the USA and then Japan, before joining the pharma industrie as medical writer in 2003 in France, the UK and now in Switzerland. I am pragmatic, goal oriented, and collaborative. Specialties: Key documents for clinical and regulatory: protocol & report - Investigator's brochure (IB)- Preclinical report - CTD module 2 - IND report - Safety report - IMPD - PI - SPC - Standard Operating Procedure (SOP for medical writing) and medical writing guidelines - Electronic Data Management System (EDMS, Documentum)
Member of the submission team and lead writer for documents such as briefing book, clinical study report, safety and efficacy clinical summaries, clinical overview, responses to the Health Authorities, safety and efficacy update. Planning of the analyses and data presentation. Ensure compliance to the company standards and the external regulatory guidelines. Ensure provision of adequate medical writing resources for the dossier. Ensure timely delivery of final documents for publishing.
Responsible for the medical writing activities (clinical/regulatory) for 3 products in development. In house writing and contractor management. Administrator of the electronic data management system (EDMS - eldorado) for the clinical group. Involved in processes & templates for medical writing. Merck Serono site (Geneva) was closed early 2013.
Responsible for all medical writing activities for clinical/regulatory documents (anti-infectious diseases). In-house and outsourcing writing, standard operating procedures (SOP) and templates. Administrator of Documentum our electronic data management system (EDMS). Novexel joined Astra-Zeneca mid 2010.
Responsible for medical writing activities for clinical/regulatory documents in oncology. Mentor of junior medical writers and publishers. Involved in standard operation procedures (SOPs) and processes for medical writing.
In charge of documents for clinical/regulatory and marketing such as technical documents (CTDs), IBs, monographs, reports, papers for publication, health information letters for patients. Therapeutic areas: infectious diseases, pain, dermatology, women health & fertility, dyslipidemia, diabetes, hypertensions, oncology. I co-managed and wrote the report for a pan-European survey on dyslipidemia (9 months, 11 countries) .