Technical Writing for the Regulatory Professional

The focus of this course was to learn and practice technical writing for the regulatory and clinical research fields, including information gathering, logical and ethical argument development, effective use of exhibits, assessing the audience for proper tone and content, as well as formal and informal communication for regulatory applications. I applied this knowledge in assignments involving creating, revising and editing a variety of regulatory documents.     

  • Construct coherent written regulatory documents.
  • Synthesize valid, scientific information to support regulatory decisions.
  • Appraise supporting regulatory documents and exhibits (e.g. laboratory records, adverse event reports) for appropriate use in argument development.
  • Defend conclusions which have been developed through research.
  • Constructively critique written documents and/or oral presentations.
  • Evaluate, revise and edit content and organization of written documents and/or oral presentations.

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