Senior Medical Writer, Pharmacovigilance

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 Evaluation Reports)Prepare clinical study reports, investigator brochures and other regulatory submissions as required.Support documentation associated with medical devices and combination products, ensuring compliance with relevant regulatory requirements.Collaborate with subject-matter experts to ensure scientific accuracy, consistency and timely delivery of documents.Drive document strategy, standards and quality across multiple development programmes.Ensure all documents meet global regulatory guidelines and company standards.What you''ll need to ..... full job details .....