Medical Writer, CNS, Biologics, Vaccines

Global Channel Management, Inc.

. Author clinical and regulatory documents for CNS development programs in a global biopharmaceutical company's Biologics Business Unit .

Posted 11/11/2026full-timeRemote • New Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory medical writing with a focus on CNS development, including authoring clinical study protocols, Investigator's Brochures, and Clinical Study Reports. Proficient in navigating ICH guidelines and collaborating with cross-functional teams to ensure compliance and timely deliverables.

Highest-signal resume keywords

Regulatory Medical WritingCNS ExperienceICH Guidelines KnowledgeClinical Study Protocol AuthoringBiologics Writing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsClinical Study ReportsInvestigator's BrochuresSubmission DocumentsRegulatory DocumentsDocument Review CyclesWriting Processes ImprovementTemplate DevelopmentStyle Guide CreationNegotiation of Document Timelines

Soft Skills

Stakeholder Agreement FacilitationCommunication SkillsCollaboration Skills

Industry Keywords

BiopharmaceuticalCNS DevelopmentGCPClinical DevelopmentPharmaBiotechCROPharmacovigilanceMedical AffairsOncology

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Author clinical and regulatory documents for CNS development programs in a global biopharmaceutical company's Biologics Business Unit
Write and edit documents that meet regulatory requirements (ICH, GCP) and company standards
Write clinical study protocols and amendments
Write Investigator's Brochures (IBs)
Write Clinical Study Reports (CSRs)
Write briefing books for health authority meetings
Write IND and NDA summary documents and other submission materials
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

Requirements

What you’ll need

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)
Oncology-only backgrounds will not be considered
Medical communications or marketing writers without regulatory documents are not a fit

Benefits

Comp & perks

Hours start at 20–40 per week, with the chance to grow hours and responsibility