Remote Medical Writer CNS, Biologics & Vaccines (No Oncology)

This role requires recent CNS writing plus biologics or vaccine experience. Oncology-only backgrounds will not be considered.This is a hands-on medical writing role for a global biopharmaceutical company's Biologics Business Unit. You'll author clinical and regulatory documents for CNS (central nervous system) development programs. Hours start at 20–40 per week, with the chance to grow hours and responsibility.What you'll write:Clinical study protocols and amendmentsInvestigator's Brochures (IBs)Clinical Study Reports (CSRs)Briefing books for health authority meetingsIND and NDA summary documents and other submission materialsWhat you'll do:Write and edit documents that meet regulatory requirements (ICH, GCP) and company standardsWork with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory, Pharmacovigilance and Medical AffairsRun review cycles, resolve reviewer comments and drive agreement among stakeholdersNegotiate document timelines and keep deliverables on scheduleHelp improve writing processes, templates and style guidesRequired:5+ years of regulatory medical writing in pharma, biotech or a CRO, as a hands-on writerRecent CNS experience (neurology or psychiatry)Biologics or vaccine writing experienceExperience authoring protocols, CSRs, IBs and submission documentsStrong knowledge of ICH guidelines and clinical developmentAvailable during U.S. East Coast hours, plus occasional 8 AM ET and 6–8 PM ET meetings with teams in JapanBachelor's degree or higher (advanced degree preferred)Not a fit: writers whose recent experience is only oncology, and medical communications or marketing writers without regulatory documents.Originally posted on Himalayas