Regulatory Medical Writer

Basel, Basel-Stadt, ch
Company: CTC Clinical Trial Consulting AG
Category: Arts, Design, Entertainment, Sports, and Media Occupations
Published on 2021-07-25 16:10:50

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.).
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