Principal Clinical Medical Writer – Remote

BioMarin Pharmaceutical Inc.; Northern (KY); Hybrid; USD 150,000 - 230,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a Principal Clinical Medical Writer to lead the medical writing function within Development Sciences.

The role emphasizes reducing CRO costs, increasing writing productivity, and ensuring consistent documentation quality across programs. The candidate will oversee medical writing staff, manage timelines, and contribute to regulatory filings while collaborating with cross-functional teams.

Qualifications

• Masters (MS) or higher degree preferred; scientific focus desirable.
• Experience writing, reviewing, or editing regulatory documents (INDs, BLA/NDAs, ISS/ISE).
• Ability to plan timelines and resources for multiple documentation projects.

Responsibilities

• Oversee Medical Writing staff and timelines.
• Draft/edit documents for clinical studies and regulatory filings.
• Support regulatory submissions and peer review of study materials.
• Coordinate cross-functional input and maintain standard processes.

Skills

Medical writing

Leadership

Timeline planning

Regulatory documentation

Cross-functional collaboration

Education

MS or higher degree preferred; scientific focus

Tools

MedDRA

WHO Drug

Job description

BioMarin Pharmaceutical Inc. is seeking a Principal Clinical Medical Writer to lead the medical writing function within Development Sciences.

The role emphasizes reducing CRO costs, increasing writing productivity, and ensuring consistent documentation quality across programs. The candidate will oversee medical writing staff, manage timelines, and contribute to regulatory filings while collaborating with cross-functional teams.