Remote Senior Medical Writer - Clinical Docs & Reg

Perceptive; United States; Remote; USD 84,000 - 121,000; Full time

Job summary

Perceptive is seeking a Senior Medical Writer to research, write, edit, and coordinate clinical documents for independent review. The role involves serving as a primary client contact, ensuring adherence to SOPs, templates, and regulatory guidelines (FDA/EMA/ICH-GCP).

You will draft, ghost-write, and support a team while maintaining high-quality documentation. Responsibilities include literature reviews, budget-conscious timelines, and collaboration with stakeholders to deliver precise

Qualifications

• Bachelor's Degree in a technical discipline (Science, Pharmacy, Nursing, or related).
• English: Fluent (written and verbal).
• Experience with regulatory documents in CRO/pharma/biotech or clinical research context.

Responsibilities

• Create, research, edit and coordinate clinical documents for independent review.
• Serve as primary client contact for medical writing projects and timelines.
• Follow SOPs, templates, and regulatory guidelines (FDA/EMA, ICH-GCP).
• Draft and ghost-write documents; support other writers as needed.
• Ensure document quality and alignment with stakeholder needs.

Skills

Interpersonal communication

Written communication

Time management

Multitasking

Critical thinking

Process improvement

Self-motivation

Stakeholder management

Proactive learning

Microsoft Office proficiency

Education

Bachelor's Degree in a technical discipline

Tools

Microsoft Word

Excel

PowerPoint

Tableau

Power BI

Job description

Perceptive is seeking a Senior Medical Writer to research, write, edit, and coordinate clinical documents for independent review. The role involves serving as a primary client contact, ensuring adherence to SOPs, templates, and regulatory guidelines (FDA/EMA/ICH-GCP).

You will draft, ghost-write, and support a team while maintaining high-quality documentation. Responsibilities include literature reviews, budget-conscious timelines, and collaboration with stakeholders to deliver precise