Remote Principal Clinical Medical Writer — Lead, Regulatory Docs

BioMarin Pharmaceutical Inc.; San Rafael, Novato (CA, CA); Hybrid; USD 172,000 - 236,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Company-sponsored medical, dental, and

Vision and life insurance

Job summary

BioMarin Pharmaceutical Inc. is seeking a Principal Clinical Medical Writer to progressively develop the Medical Writing function within Development Sciences.

This role oversees medical writing staff, aligns with program needs, and ensures high-quality regulatory documentation across development programs. You will draft/edit protocols, CSRs, and regulatory reports, manage timelines, and support cross-functional teams.

Qualifications

• Masters (MS) or higher degree preferred; scientific focus desirable.
• Evidence of medical writing career development desirable, e.g. related certificates.
• Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents.
• Ability to interpret and apply complex regulatory requirements and guidance.
• Ability to plan timelines and resources for multiple documentation projects.

Responsibilities

• Oversee Medical Writing staff and coordinate with Head of Medical Writing to set program timelines.
• Draft and edit clinical study documents (protocols, amendments, ICFs, CSRs).
• Draft and edit safety and efficacy documents (IBs, PSRs, PBRERs, DSURs).
• Prepare documents for regulatory filings (briefing books, CTD modules).
• Manage cross-functional study team involvement and document review processes.
• Represent Clinical Medical Writing in cross-functional meetings and provide peer review support.

Skills

Medical Writing

Regulatory knowledge

Leadership

Project Management

Cross-functional collaboration

Education

MS or higher degree

Medical writing certification desirable

Tools

MedDRA

WHO Drug

eCTD knowledge

Job description

BioMarin Pharmaceutical Inc. is seeking a Principal Clinical Medical Writer to progressively develop the Medical Writing function within Development Sciences.

This role oversees medical writing staff, aligns with program needs, and ensures high-quality regulatory documentation across development programs. You will draft/edit protocols, CSRs, and regulatory reports, manage timelines, and support cross-functional teams.