Principal Medical Writer

Full Time in Biotechnology , in Consulting
  • Europe, USA & Canada View on Map
  • Apply Before : 23rd April 2023
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Job Detail

  • Remote Work Yes

Job Description

I am recruiting for a Principal & Associate Principal medical writer with a global mid sized CRO.

  • Opportunity for career advancement that align to your professional aspirations.
  • Collaborative work environment
  • Competitive benefits and compensation packages – paid for performance
  • Genuinely impactful work that will make a difference to the lives of people all over the world


  • Working with client and internal and partners to develop regulatory documents
  • Lead a project team in writing of high-quality documents
  • Serve as liaison and subject matter expert internally and for clients
  • Author documents per client specifications
  • Author documents per regulatory authority guidelines and requirements
  • Act as client advisor and proactive consultant
  • Provide coaching to junior staff for all documents and ensure all staff comply with company SOPs and training requirements

Experience required:

  • 8-10+ years of regulatory writing experience with clinical- related documentation
  • Understands regulatory requirements
  • Knowledge of global health authority requirements
  • Collective experience writing and leading a range of documents from start to finish (e.g. CSRs, PV, Submissions)
  • Strong understanding of the document creation process and of the drug development lifecycle
  • Previous CRO or Pharma background


Please only apply for this position if you have the experience listed above!

Apply here or send your CV to:

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