Medical Writer at DOCS

Remote
DOCS

Medical Writer

Ref #: 17707

Employment type: Permanent – Full-Time

Location: Remote/Home-based

Description

Principle Responsibilities:

  • Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documentation.
  • Contributes to project plan concerning organization and table layout for a specific document.
  • Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
  • Review study concepts and edit protocols for consistency, progression, structure, and grammar.
  • Review statistical analysis plans and incorporate into clinical study reports.
  • Drive the document preparation process, receive and review primary statistical output, draft and distribute document for review, and compile comments and edits as necessary.
  • Participate in team and client meetings as requested.

Education and Experience Requirements/Qualifications:

  • Advanced degree in a relevant scientific/clinical/regulatory field preferred
  • At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
  • Global regulatory submission experience.
  • Excellent writing skills.
  • Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
  • Knowledge of current requirements and guidelines applicable to submission documents
  • Excellent interpersonal and oral communication skills.
  • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Ability to prioritize multiple projects

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