Senior Medical Writer - Remote

Overview

The Senior Medical Writer will be responsible for drafting and editing clinical documents, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to support drug development processes.

In Short

• Drafts and edits clinical study documents and regulatory filings.
• Manages study team participation in document preparation.
• Represents Global Medical Writing at cross-functional meetings.
• Builds partnerships with various teams to meet stakeholder needs.
• Provides peer review and editing support for regulatory documents.
• Develops and reviews standard processes within Global Medical Writing.
• Adheres to industry standards and departmental procedures.
• Works effectively with cross-functional groups within BioMarin.
• Capable of leading cross-functional teams under strict timelines.
• Translates complex scientific concepts into clear regulatory text.

Requirements

• Bachelor’s or higher degree required; scientific focus desirable.
• Experience in medical writing within the pharmaceutical industry.
• Advanced understanding of drug development processes.
• Experience writing and editing clinical study reports.
• Proficient in Microsoft Word, Excel, and document management software.
• Knowledge of regulatory requirements for clinical documents.
• Strong project management and communication skills.
• Detail-oriented with good conflict management skills.
• Ability to work on multiple tasks and shifting priorities.
• Intermediate to advanced presentation skills.

Benefits

• Opportunity to work in a leading biotechnology company.
• Engagement in innovative science and drug development.
• Collaborative work environment with cross-functional teams.
• Potential for career advancement in medical writing.
• Competitive salary and benefits package.