Medical Writer, CNS, Biologics, Vaccines

Job not on LinkedIn

🔥 1 hour ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 25%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 365 days.
• No salary listed.

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Global Channel Management, Inc.

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11 - 50 employees

💼 Consulting

🎯 Recruiter

☁️ SaaS

Consulting • Recruitment • SaaS

Global Channel Management, Inc. is a technology company that specializes in recruiting and staff augmentation services. With over a decade of experience, their account managers and recruiters help organizations address challenges in acquiring skilled talent, manage fluctuating skill needs, and reduce training and labor costs. They focus on providing companies with the best talent to meet various staffing needs and timelines across different verticals.

📋 Description

• 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

• 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

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

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