Remote Senior Clinical Medical Writer

BioSpace; Home (KS); Hybrid; USD 150,000 - 210,000; Full time

Job summary

BioMarin Pharmaceutical is seeking a Principal Clinical Medical Writer to evolve the medical writing function across development programs. This role provides leadership and continuity of knowledge for investigational products and indications, aiming to improve documentation quality and reduce external costs.

You will author and edit protocols, CSRs, and clinical study reports, and prepare regulatory briefing books while leading cross-functional teams to ensure compliant, timely deliverables in a

Qualifications

• Formal medical writing training and regulatory standards knowledge.
• Experience drafting protocols, CSRs, and briefing books.
• Familiarity with MedDRA and regulatory guidance.

Responsibilities

• Oversee Medical Writing staff and timelines.
• Draft and edit protocols, amendments, ICFs, and CSRs.
• Prepare regulatory filings and briefing books (CTD Modules 2/5).
• Coordinate study team reviews, timelines, and comment adjudication.
• Provide peer review for regulatory documents.
• Adhere to procedures, templates, and industry standards.

Skills

Clinical studies

Documentation management

Leadership

Project management

Medical writing

Regulatory understanding

Education

Master's degree (MS) or higher

Job description

BioMarin Pharmaceutical is seeking a Principal Clinical Medical Writer to evolve the medical writing function across development programs. This role provides leadership and continuity of knowledge for investigational products and indications, aiming to improve documentation quality and reduce external costs.

You will author and edit protocols, CSRs, and clinical study reports, and prepare regulatory briefing books while leading cross-functional teams to ensure compliant, timely deliverables in a