Medical Writer(m/w/d)

Farkas Kiss Endre legjobb állása Croma-Pharma Ges. m.b.H

info@cromapharma.com;complaint@croma.at;office@croma.at

Bewerbung fur Team Lead Life Cycle Management - Manufacturing Science & Validation Engineering (m/w/d)

Levél szövege

Lieber Croma-Pharma Ges. m.b.H!

Ich möchte mich bei Ihrem Unternehmen als Medical Writer(m/w/d) bewerben. 
Ich bin ein Fullstack-Entwickler, bei dem ich meine 10-jährige Erfahrung mit verschiedenen Technologien einsetzen kann.

Ich habe meinen Lebenslauf an diese E-Mail angehängt.

Wir freuen uns darauf, von Ihnen zu hören!


Endre Farkas Kiss "Sodika"
Java and PHP Fullstack Developer, Nudist, Vlogger

https://www.linkedin.com/in/farkas-kiss-63bb9210a
https://sodika.org

Álláshirdetés szövege

Medical Writer(m/w/d)CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.We are expanding our Clinical Development department and therefore looking for a/ an Medical Writer. Ihre AufgabenWrite, edit, compile and maintain documents related to clinical development activities and CE marking activities (such as Clinical Evaluation Reports and Plans, Post Market Clinical Follow Up Plans and Reports) according to 93/42/EEC and 2017/745/EU Coordinate and manage the review and approval process of documents, including comment reconciliation and timely completion Review and edit documents prepared with the help of service providers and medical experts Contribution to the continuous improvement of internal processes, maintaining of SOPs, definition and implementation of working practices, etc. Support the clinical team in publishing study results in peer- reviewed journals and through poster and slide presentations at international congresses Support global submissions to regulatory authorities including writing of clinical study reports, investigator's brochures, and CTD summaries and overviews Ihr ProfilAt least 3 years' experience in regulatory writing, or extensive relevant medical writing experience through clinical research activities in the pharmaceutical industry Life-science background Knowledge of regulatory writing standards and relevant guidelines (such as 93/42/EEC,2017/745/EU, ISO 14155, ICH-GCP, FDA/CFR) Proven writing skills, with the ability to convey complex data in a clear, concise and correct way and attention to formal details Good understanding of the clinical development process, including basic knowledge of statistics and regulatory procedures Used to work to tight timelines both independently and within a team Fluent in English (oral and written) and German, preferable Wir bietenWe offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you! For this position, a salary of EUR 49.804,58, - (38h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience. Jetzt bewerben