Senior Manager affaires règlementaires dispositif médical – F/H
Région : Île-de-France
Rémunération : plus de 70K€
Famille de métier : Réglementaire
Présentation société
Novocure développe et commercialise un traitement breveté d’un genre nouveau destiné à combattre les tumeurs solides. Depuis plus de 20 ans, Optune incarne, grâce à ses fameux champs électriques alternatifs, les champs de traitement de la tumeur (TTFields), le premier traitement obtenant des progrès significatifs dans la prolongation de la survie des personnes concernées. Ce traitement repose sur un dispositif médical portatif que les patients peuvent intégrer à leur vie quotidienne et qui leur permet de rester mobiles et actives.
Pour Novocure, l’homme est au centre de l’action. Nous sommes à la recherche de personnes qui s’épanouissent dans un environnement en mutation rapide et qui, avec enthousiasme, sont prêtes à emprunter de nouvelles voies dans le traitement du cancer. Nos employés, innovants et non conventionnels, veulent faire la différence dans la vie des patients atteints d’un cancer.
In this role as Senior Compliance & Regulatory Affairs Pharmacist France you will be Serving as a local liaison for French compliance, advertising and promotional matters. You will be responsible for the Implementation of the “charter of information on medical devices” in France.
- Provide support to Novocure’s French affiliate related to the development and distribution of CE marked medical devices in France
- Strategic review of commercial projects, including product advertising, informational material, communication on human health and diseases, with regard to the rules laid down by the ANSM, the MDR, and any other applicable rules and regulations in France
- Review and approval of a large volume of promotional and scientific materials for use in France in compliance with applicable laws and regulations
- Participation in digital communication projects and implementation of electronic platforms and tools for products and environment (app, webinar, etc.) by providing the appropriate regulatory support
- Quality: support Novocure France for the compliance, organization and documentary system with the requirements of the new “charter of information on medical devices” and to facilitate its future certification.
- Collaborate with the broader Compliance and Brand team in addition to Commercial, and Medical Affairs team members to create solutions for developing compliant relationships with healthcare professionals and government officials
- Work in close cooperation with EMEA Compliance and Brand team to create a culture of compliance.
Descriptif du profil
- Qualifications:
- Pharmacist with minimum 5 years’ experience in the review and approval of marketing and scientific materials in France
- Perfect command of French both written and spoken
- Fluent in English, spoken (preferably written as well); any further languages are of benefit
- Knowledge:
- Strong collaboration skills
- Must work confidently, proactively and assertively with a high level of independence
- Good judgement, ability to adapt and change in a shifting environment
- Understanding of relevant industry laws and rules (e.g., French local regulations, Foreign Corrupt Practices Act, MedTech Europe and other regional codes)
Postuler
Natalia Kochanowicz
interviewsemea@novocure.com