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

Globalchannelmanagement; Edison (NJ); Remote; USD 90,000 - 130,000; Full time

Job summary

Globalchannelmanagement is seeking a hands-on regulatory medical writer for its Biologics Business Unit. You will author CNS clinical and regulatory documents (protocols, IBs, CSRs, submission materials) and ensure compliance with ICH and GCP.

The role requires 5+ years of regulatory medical writing in pharma/biotech/CRO, with recent CNS experience (neurology or psychiatry) and biologics or vaccine writing.

Qualifications

• 5+ years of regulatory medical writing in pharma, biotech or CRO.
• 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.

Responsibilities

• Write and edit documents that meet regulatory requirements (ICH, GCP) and company standards.
• Work with Clinical Development, 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.

Skills

Regulatory medical writing

CNS experience

Biologics writing

Vaccine writing

ICH guidelines knowledge

Education

Bachelor's degree or higher

Advanced degree preferred

Job description

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.