Position Overview
Your new company
Are you an experienced Senior Medical Writer looking for your next long-term contract opportunity?
I am currently partnering with a leading global pharmaceutical organisation seeking a Senior Medical Writer to join their clinical and regulatory writing team on an initial 12-month contract.
This role sits within a high-performing global team and will suit a writer who is confident leading the development of complex regulatory and safety documentation whilst collaborating with cross-functional stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics and Medical Affairs.
Your new role
Lead the preparation, review and delivery of high-quality clinical and regulatory documents.
Author and coordinate clinical study protocols and protocol amendments.
Develop Pharmacovigilance and aggregate safety reports including:
DSURs (Development Safety Update Reports)
PBRERs (Periodic Benefit-Risk Eval...