Remote CNS Biologics Medical Writer - Regulatory Submissions

Globalchannelmanagement; Edison (NJ); Remote; USD 110,000 - 160,000; Full time

Job summary

Globalchannelmanagement is seeking a hands-on regulatory medical writer for its Biologics Business Unit to author CNS-focused clinical and regulatory documents. You will write Protocols, IBs, CSRs, and submission materials, ensuring ICH/GCP compliance and high-quality standards.

The role requires 5+ years in regulatory medical writing, recent CNS experience, and biologics or vaccine writing background. US East Coast hours with occasional Japan meetings; Bachelor's or higher degree preferred.

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

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

Document management

Cross-functional collaboration

Education

Bachelor's degree or higher

Job description

Globalchannelmanagement is seeking a hands-on regulatory medical writer for its Biologics Business Unit to author CNS-focused clinical and regulatory documents. You will write Protocols, IBs, CSRs, and submission materials, ensuring ICH/GCP compliance and high-quality standards.

The role requires 5+ years in regulatory medical writing, recent CNS experience, and biologics or vaccine writing background. US East Coast hours with occasional Japan meetings; Bachelor's or higher degree preferred.