RESPONSIBILITIES:
  • Creating clinical study protocols and reports, investigator’s brochures and regulatory submissions and ensuring consistency and compliance within the documents
  • Act as a subject matter expert fielding queries from within the team and other internal stakeholders
  • Analysing and interpreting data
  • Supporting study projects, plans and statistical output
  • Taking part in product development plans
  • Assisting in in creating SOPs and related procedures
CANDIDATE:
  • You will hold a PhD and strong relevant experience working within Biotech and Orphan Drugs
  • Strong experience in writing and editing clinical regulatory documents
  • Ability to analyse data and solve the conflicts
  • Project management skills
  • Working collaboratively
  • Strong communication skills