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Senior Medical Writer (f/m/x)

ABOUT US

ICRC-Weyer is an owner-managed contract research organisation and consulting firm with 25 years of history, based in Berlin. To our clients from the international pharmaceutical and medical device sectors, we offer functional and consulting services, covering the product life cycle from clinical development to post-marketing. Medical writing, biostatistics, and data management are among the core services of our portfolio. The satisfaction of our clients and the well-being of our employees are our top priority and the key to our success. You are invited to be a part of that! We are currently looking for:

SENIOR MEDICAL WRITER (F/M/X) office-based in Berlin

YOUR RESPONSIBILITIES

  • Writing and compilation of documents for regulatory submission during all phases of clinical development and the post-marketing period, such as Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, Risk Management Plans
  • Detail-oriented review of complex documents, assurance of consistency within and across documents
  • Project management, incl. client communication and organization of internal project teams

YOUR QUALIFICATIONS

  • Industry experience as a Medical Writer, including experience in Clinical Study Protocols, Clinical Study Reports (incl. Phase I), Investigator’s Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, Risk Management Plans. As a result of this experience, the candidate will be able to successfully
    • Write each of the above-named document types with minimal supervision
    • Review each of these document types and provide input for improvement
    • Mentor less experienced colleagues in writing any of these documents
  • Ability to generate client satisfaction by
    • Working with the client to identify document specifications, and to define the scope of work and timelines
    • Meeting these specifications, scope, and timelines, and in accordance with ICRC-Weyer’s and the clients quality standards, as well as regulatory standards
    • Successfully prioritizing and to delegating tasks, in order to meet tight timelines
    • Identifying potential issues and successfully working towards the resolution with other departments at ICRC-Weyer /with the client
  • Academic degree in a relevant field
  • Excellent English language skills
  • Proficiency in literature database searches

OUR OFFER

  • A friendly, diverse, and committed team with flat hierarchies
  • Opportunities for professional development and a high degree of personal responsibility
  • A permanent contract with a competitive salary and an attractive retirement package

Please send your application, incl. desired salary, to jobs@icrc-weyer.com. We look forward to hearing from you!

ICRC-Weyer GmbH | Boelschestrasse 35 | 12587 Berlin | Germany | www.icrc-weyer.com

Tel. +49 (30) 40 39 37 – 119 | Fax +49 (30) 40 39 37 – 118 | jobs@icrc-weyer.com

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