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Senior Medical Writer

Parexel International Corporation

Southeast, Remote, United States of America

Position Purpose:

  • The Senior Medical Writer (Sr MW) writes/edits clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other documents for submission to the Food and Drug Administration (FDA) and other regulatory authorities; and develops abstracts, manuscripts, and presentation materials summarizing clinical data.

Primary Duties:

  • Write/edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
  • Develop manuscripts and presentation materials
  • Develop and manage timelines for document development
  • Coordinate multi-document projects
  • Represent medical writing on study teams and cross-functional strategic teams
  • Work on problems of diverse scope where decisions are based upon a mixture of analysis, wisdom, experience, judgment, and rigorous logic and methods
  • Acts independently to determine methods and procedures on new assignments action
  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
  • Adhere to EP and Client SOPs and processes

Skills and Education:

  • BA/BS in life sciences and a minimum of 5 years’ experience or MS/PhD and a minimum of 2 years’ experience
  • Module 2 writing experience required
  • Solid understanding of FDA/ICH guidelines and GCPs
  • Experience preparing clinical regulatory documents and scientific publications
  • Expert abilities in Microsoft Word, Excel and PowerPoint
  • Experience with Adobe Acrobat
  • Prior NDA/BLA/MAA submission experience
  • Strong written and verbal communication skills
  • Ability to coordinate and prioritize multiple projects in a fast-paced environment
  • Ability to anticipate and address issues with potential to impact timelines

Job posted: 2023-03-29

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