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 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