Associate Director of Clinical Editing in Medical Writing

☞ argenx

Aussicht: 140

Update Tag: 04-11-2025

Ort: Ghent East Flanders

Kategorie: Gesundheit / Medizinische Versorgung

Industrie: Biotechnology Research

Position: Mid-Senior level

Jobtyp: Full-time

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Jobinhalt

PURPOSE OF THE FUNCTIONThe Associate Director of Clinical Editing will ensure the accuracy of content in clinical and regulatory submission documents prepared by Medical Writing in addition to training and supervising clinical editors. This role reports to the Global Head of Clinical Editing.Roles And Responsibilities
  • Responsible for performing quality reviews and editing clinical documents, regulatory submissions, and other related documents
  • Performs detailed data accuracy reviews and fact-checks statements in clinical and regulatory documents, tables, literature summaries, and other internal documents
  • Substantively edits and proofreads documents to correct and streamline grammar, spelling, style, and format
  • Verifies that document content is consistent with internal, client, and related authority guidelines
  • Formats, styles, and troubleshoots functionality and presentation of documents and templates
  • Responsible for training, supervising, and mentoring clinical editors. Provides high-quality feedback to ensure proper development of clinical editors.
  • Contributes to periodic reviews of the quality control process
  • Communicates with medical writers and other team members to ensure the accuracy of documents
  • Responsible for inspection-readiness of medical writing activities
Skills And Competencies
  • Excellent language skills (reading, writing, editing, team communication)
  • Ability to interpret clinical data and literature
  • Ability to follow instructions and apply resourceful insight to problem-solving
  • Project management skills
  • Ability to communicate with professionals from a variety of backgrounds
  • Knowledge of the AMA Manual of Style, other style guides, and any guidelines related to assigned projects
  • Expertise in Microsoft Word, including advanced formatting, styles, cross-referencing, bookmarks, and other related skills
  • Fluent in English
  • Expertise in Microsoft Word and understanding of Acrobat/PDF software
  • Experience with Veeva, SharePoint, PerfectIt, and StartingPoint is a plus
Education, Experience, And Qualifications
  • College degree or 2+ years of education in a related field
  • At least 10 years of related experience in clinical and regulatory document review or medical editing
  • Submissions experience (QC of CTD Modules 2 and 5) is preferred
  • Experience as a line manager is preferred
Applications must include a cover letter.Keywords:Document Reviewer, Document QC, Document Quality Control, Medical Documentation Review, Quality Control Reviewer, QC Specialist
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Frist: 19-12-2025

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