Natural Scientist, Physician as Medical Writer - Regulatory Affairs, C

Posted on Apr 17, 2019 by ICRC-WEYER GmbH

Friedrichshagen, Berlin Germany
Health Care
14 Mar 2019
Annual Salary
Full-Time
About usICRC-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:
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
Good understanding of drug development processes and key regulatory requirements (incl. ICH guidelines and EMA GVP legislation)
Proficiency in literature database searches
Excellent English language skills
MD, or PhD in a relevant discipline
Curiosity and willingness to acquire expertise in new fields.
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

Reference: 694604522

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