Regulatory Writer

United Kingdom,

Posted:22 days ago
Location:United Kingdom,
Job Ref:BH-33451-1
Job Type:Contract
Salary:£500 per day
Expiry date:12/6/2022
Contact:Callum Costello
Contact Email:callum.costello@xplorelifescience.com
This is an exciting fully remote, long term contract opportunity working for a fortune 500 pharmaceutical company in the UK. (OUTSIDE IR35)

Our client is seeking a writer/author to service there clinical department in the Oncology therapeutic area. You will work within a large global team as a Lead Writer/ Author. We are looking for a candidate with experience of preparing Investigational New Drug (IND) submissions, Clinical Study Protocols (CSPs), Investigator Brochures (IBs), and experience of late phase submissions.

Requirements:
  • Experience within authoring documents for clinical studies in the area of Oncology
  • Experience in preparing IND Submissions. 
  • Proven experience in writing protocols, CSRs, IBs, Briefing Document and ECTD documents. 
  • Ability to lead a matrixed team of colleagues 
  • Ability to infuence key stakeholders and senior leadership
  • Excellent communication skills written and oral. 

Apply now