Senior Medical Writer - Regulatory Submissions & Strategy

BioMarin Pharmaceutical Inc.; San Rafael (CA); On-site; USD 142,100 - 195,360; Full time

Benefits offered by this job

Company-sponsored medical insurance

Annual discretionary bonus

Comprehensive benefits package

Job summary

A global biotechnology company in San Rafael is seeking a Senior Medical Writer who will manage clinical documentation and project management skills to develop and finalize vital documents used in clinical studies. The ideal candidate will have a strong background in medical writing, a Bachelor’s or higher degree, and the ability to handle multiple tasks while ensuring regulatory compliance. This role offers competitive compensation and a comprehensive benefits package.

Qualifications

• Up to 6 years as a medical writer in pharma or 10 years in medical writing.
• Experience writing and editing protocols and clinical study reports.
• Proficient in style guides and regulatory guidance.

Responsibilities

• Draft and edit clinical study documents.
• Manage study-team participation and meetings.
• Collaborate with cross-functional groups to meet needs.

Skills

Clinical study document drafting and editing

Project management skills

Scientific communication

Regulatory requirements knowledge

Education

Bachelor's or higher degree

Tools

Microsoft Word

Adobe Acrobat

Veeva

Job description

A global biotechnology company in San Rafael is seeking a Senior Medical Writer who will manage clinical documentation and project management skills to develop and finalize vital documents used in clinical studies. The ideal candidate will have a strong background in medical writing, a Bachelor’s or higher degree, and the ability to handle multiple tasks while ensuring regulatory compliance. This role offers competitive compensation and a comprehensive benefits package.