Remote CNS Biologics & Vaccines Medical Writer

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

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.