CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a pan-European specialist staffing organisation with offices in Basel, London and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing
Regulatory Medical Writer (897486-GBA)
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next year, is looking a Regulatory Medical Writer for an initial 12 months contract based in Basel, Switzerland.
Our client is looking for someone with at least 1 years of experience as a Medical Writer in Regulatory Affairs within the pharma/biotech industry, experience compiling pre-clinical sections of regulatory documents, and a Master’s or PhD in a life sciences subject.
Serve on early development and life cycle teams as the preclinical medical writer to support development of individual compounds in a wide range of therapeutic areas;
Compile, edit, and manage review of preclinical sections of regulatory documents (IBs, briefing books, IND/NDA/MAA Modules 2.4, 2.6, 4) authored by cross-functional teams;
Perform quality control checks of the above documents to ensure accuracy, completeness, and scientific robustness of content, consistency of reported preclinical data, compliance with company style guides;
Review, edit, and archive nonclinical study reports using an electronic document system;
Support preparation and submission of preclinical publications.