Remote Work Yes
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
- 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: firstname.lastname@example.org