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Regulatory Medical Writer (897486-GBA)

CTC Resourcing Solutions

 
Basel, Switzerland
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CTC Resourcing Solutions

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.

Main Responsibilities:

  • 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.

Qualifications and Experience:

  • Swiss working/residency permit and/or Swiss/EU-Citizenship required;
  • Masters or PhD (highly preferred) degree in life sciences;
  • Excellent written and spoken English including scientific terminology;
  • At least 1 year of experience as medical writer or in a similar role (scientific editor, regulatory specialist), ideally within a pharma/biotech company and/or CRO;
  • Ability to make own judgement about robustness of a scientific statement and whether it is supported by the available data;
  • Ability to effectively communicate with other members of a cross-functional team (e.g., preclinical and clinical researchers, regulatory specialists, project managers) on a daily basis;
  • Ability to prioritize tasks while working on multiple projects in parallel;
  • Sharp eye for detail;
  • Advanced knowledge of Microsoft Word (styles, cross-links, bookmarks, tracked changes, etc.).

Adresse

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Website http://www.ctcresourcing.com

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