EMEA Medical Writer / Clinical Documentation MEDDEV

Highly Competitive
  1. Permanent
  2. Medical Writing
  3. Germany
Frankfurt am Main, Germany
Posting date: 18 Feb 2020
MC.KR.28038

A global technology company in the medical device industry is currently recruiting for an EMEA Medical Writer / Clinical Documentation MEDDEV position. This company provides high-quality intraocular lenses for use in the treatment of cataracts. Based in Germany, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.

Job Responsibilities:

  • Manage, author and review budget assigned clinically relevant documents.
  • Primary deliverables of role include:
    • Clinically relevant documents for regulatory purposes (CEP/CER) incl. literature reviews.
    • PMCF-P/PMCF/PMCF-ER documents.
    • IR/CSR/DoF.
    • CIP/CIB.
    • Paper/publications/Newsletter.
    • GOPs and related documents.

Skills and Requirements:

  • Scientific education (preferably Master/PhD/MD level) in medical and/or related science.
  • 5 years of experience in clinical, regulatory scientific position in industry or academic setting.
  • Advanced scientific writing skills.
  • Ability to assess information critically and systematically.
  • Ability to combine and translate complex clinical and technical information from different sources in a simple manner in oral and written form.
  • Ability to thoroughly understand clinical data analysis and study designs concepts.
  • Experience in medical device regulations.
  • Ability to participate in cross-functional collaboration.
  • MEDDEV 2.7.1, MEDDEV 2.7.2, MEDDEV 2.12.2
  • MDD 93/42/EEC, MDR 2017/745.
  • Proficient in database systems and Microsoft Office.
  • Able to speak and write fluently in English and German.
  • Able to work within international environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Kain Rix at 0203 854 2623 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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