Medical Writer

Our client is dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. They are seeking a REMOTE Medical Writer to lead their clinical regulatory writing of scientific publications, clinical studied and submission- ready documents. This person will be responsible for taking scientific knowledge and communicating it in a form suitable for the target audience which includes regulators, clinicians, patients, lay people, among others.

 

Duties and responsibilities

  • Lead the overall timeline planning and preparation of the clinical section and update for global regulatory submissions
  • Partner and collaborate with clinical and regulatory team members in the preparation of clinical protocols and regulatory documents
  • Communicate and coordinate with line function team members to gather, organize and compile information towards the development and planning of writing scientific, clinical and regulatory documents
  • Communicate internally on deliverables needed, writing process and timelines, and hold team members accountable to agreed-upon dates for deliverables
  • Write articles and/or reports on research discovery results connected to Discovery programs to support our publication strategy; collaborate with research scientists to prepare abstracts and presentations

 

Skills and knowledge

  • 5+ years of relevant writing experience in the biotechnology/pharmaceutical industry
  • Strong communication skills and aptitude for communicating scientific and clinical information in a succinct manner
  • Meticulous attention to detail and critical thinking, with ability to correct grammar and provide consistency, clarify and accuracy
  • Thorough understanding of the drug development process, and expertise with CTD document content and templates