Senior Medical Writer - Regulatory Documentation Expert

biomarin; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

BioMarin is seeking a Senior Medical Writer to manage the documentation process for clinical studies. This role involves drafting and editing essential documents, ensuring compliance with regulatory standards, and collaborating with cross-functional teams.

The ideal candidate will have experience in clinical writing and a strong understanding of drug development processes. This position offers the chance to work in a highly dynamic environment focused on improving patient outcomes.

Qualifications

• Experience writing, reviewing, or editing clinical study reports required.
• Advanced understanding of drug development process from discovery to market.
• Intermediate to advanced knowledge of regulatory requirements for clinical documents.

Responsibilities

• Drafts and edits documents for clinical studies including protocols and reports.
• Manages document review processes and cross-functional team meetings.
• Adheres to departmental procedures and technical standards.

Skills

Medical Writing

Project Management

Communication Skills

Education

Bachelor’s degree in a scientific field

Tools

Microsoft Word

Excel

Adobe Acrobat

MS Project

Job description

BioMarin is seeking a Senior Medical Writer to manage the documentation process for clinical studies. This role involves drafting and editing essential documents, ensuring compliance with regulatory standards, and collaborating with cross-functional teams.

The ideal candidate will have experience in clinical writing and a strong understanding of drug development processes. This position offers the chance to work in a highly dynamic environment focused on improving patient outcomes.