Principal Strategic Medical Writer - Remote

Overview

The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents that support the company's objectives.

In Short

• Independently writes clinical and regulatory documents.
• Coordinates review, approval, and quality control processes.
• Conducts review meetings with team members.
• Communicates deliverables and timelines to team members.
• Contributes to project management strategies.
• Develops expert knowledge of regulations and guidance.
• Identifies and proposes solutions for writing process issues.
• Works independently with R&D Quality Assurance.
• Maintains an inspection-ready approach.
• Collaborates with cross-functional teams.

Requirements

• 5+ years of experience in bio-pharmaceutical industry.
• Bachelor's Degree or higher in a scientific discipline.
• Outstanding written and oral communication skills.
• Proficient in assimilating and analyzing complex data.
• Experience writing clinical documents following guidelines.
• Advanced understanding of drug development and clinical research.
• Excellent writing skills for communicating complex information.
• Ability to oversee multiple projects simultaneously.
• Strong organizational and problem-solving skills.

Benefits

• Comprehensive benefits package including medical/dental/vision insurance.
• Paid time off including vacation, holidays, and sick leave.
• Opportunity to participate in short-term and long-term incentive programs.