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About the role
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 amendments
Investigator's Brochures (IBs)
Clinical Study Reports (CSRs)
Briefing books for health authority meetings
IND and NDA summary documents and other submission materials
What you'll do:
Write and edit documents that meet regulatory requirements (ICH, GCP) and company standards
Work with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory, Pharmacovigilance and Medical Affairs
Run review cycles, resolve reviewer comments and drive agreement among stakeholders
Negotiate document timelines and keep deliverables on schedule
Help improve writing processes, templates and style guides
Required:
5+ years of regulatory medical writing in pharma, biotech or a CRO, as a hands-on writer
Recent CNS experience (neurology or psychiatry)
Biologics or vaccine writing experience
Experience authoring protocols, CSRs, IBs and submission documents
Strong knowledge of ICH guidelines and clinical development
Available during U.S. East Coast hours, plus occasional 8 AM ET and 6–8 PM ET meetings with teams in Japan
Bachelor'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
