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

Responsibilities:

• 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: jessica.banfield@albionryeassociates.com