Contract Medical Writer - Remote

Overview

The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

In Short

• Drafts and edits documents for regulatory submissions including CTDs and RtQs.
• Drafts and edits clinical study documents such as protocols and informed consent forms.
• Manages study team participation in document preparation.
• Adheres to departmental procedures and industry standards.
• Works effectively with cross-functional groups within BioMarin.
• Requires at least 5 years of medical writing experience.
• Familiar with the drug development process and clinical study documentation.
• Intermediate to advanced knowledge of document content preparation.
• Proficient in Microsoft Office Suite.
• Detail-oriented with strong communication skills.

Requirements

• Bachelor’s or higher degree; scientific focus desirable.
• Experience in medical writing in the pharmaceutical industry.
• Knowledge of regulatory requirements for clinical documents.
• Ability to manage multiple tasks and shifting priorities.
• Good conflict management skills.
• Experience with clinical study data collection and reporting.
• Ability to interpret clinical data presentations.
• Experience writing and editing INDs and BLAs/NDAs preferred.
• Familiarity with AMA, CBE, and Chicago Style Manuals.
• Evidence of medical writing career development desirable.

Benefits

• Opportunity to work in a leading biotechnology company.
• Hybrid work model (1-2 days in office).
• Collaborative work environment with cross-functional teams.
• Professional development opportunities.
• Contribute to meaningful advances in patient care.