Rédacteur Médical -CDI - H/F- Senior Regulatory Medical Writer
Rédacteur Médical -CDI - H/F- Senior Regulatory Medical Writer
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Job Description
Who we are
Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.
Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avne Klorane Ducray Ren Furterer A-Derma Naturactive Pierre Fabre Oral Care.
Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation a government-recognized public-interest foundation while a smaller share is owned by its employees via an employee stock ownership plan.
In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.
Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.
Your mission
Nous recrutons en CDI un(e) Rdacteur(trice) Mdical(e) rglementaire snior pour rejoindre le dpartement/service de rdaction mdicale compos de 5 personnes.
Votre mission principale consiste produire ou vous assurer de la production de documents cliniques dans le respect des requis rglementaires (EMA/FDA notamment).
Plus prcisment vous:
- Coordonnez lensemble des activits de rdaction de protocoles rapports dtudes cliniques interventionnelles briefing books dossier denregistrement/variation/renouvellement dAMM pour la partie clinique des activits relatives aux publications et postage dans les bases de donnes rglementaires;
- Coordonnez galement toute lactivit de sous-traitance en rapport avec les projets de rdaction mdicalequi vous seront confis;
- En conformit avec le rglement europen vous rdigez ou superviser la sous-traitance de rdaction des rsums dtude en langage profane;
Flexibilit sur la localisation du poste.
Nous offrons un package rmunration/avantages attractifs : Intressement participation Actionnariat Pierre Fabre avec abondement Mutuelle sant et prvoyance 16 RTT en plus des CP participation transport collectif CE
What are your main assignments:
Writing of deliverables in accordance with the applicable regulations in force
Manage the writing of Study documents and dossiers in full autonomy in coordination with the function leads
Act as Lead Medical Writer or oversight outsourced medical activities
Ensure compliance with deadlines and the quality of the files submitted to customers
Contribute to regulatory intelligence and maintain high level of knowledge in MW activities
Lay language writing skill could be a plus
Who you are
Vous tes issu(e) dune formation suprieure de type PhD MD or PharmD et avez au moins 7 ans dexprience en rdaction mdicale rglementaire.
Vous savez vous exprimer en anglais couramment dans le cadre dune utilisation quotidienne et avez dexcellentes capacits rdactionnelles.
Vous avez un bon niveau de connaissances en statistiques et de lenvironnement rglementaire du dveloppement clinique et des tudes cliniques.
Vous matrisez pack office Microsoft et un logiciel de rfrencement bibliographique (endnote).
La connaissance de Veeva serait un plus.
Vous tes laise avec les guidelines rglementaires de lEMA et de la FDA.
Qualifications and Experience:
Advanced degree (e.g. PhD MD or PharmD) in a scientific or medical discipline
Min 7 years of experience in regulatory medical writing within the pharmaceutical or biotechnology industry
Strong writing and communication skills in english
Ability to work independently and in a team environment
Strong knowledge of regulatory guidelines and submission processes (EMA and FDA)
Ability to manage multiple projects and prioritize tasks effectively
Attention to detail and ability to ensure accuracy of scientific information
We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.
Required Experience:
Senior IC
Employment Type
Full-Time
