Medical Writer - Remote

Overview

The medical writer is responsible for providing clinical regulatory document support to clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the clinical writing process.

In Short

• Responsible for preparing and compiling data into regulatory documents.
• Communicates deliverables and timelines to team members.
• Identifies solutions to issues during the writing process.
• Ensures compliance with established guidelines and conventions.
• Conducts review meetings and interfaces with teams.
• Produces high-quality clinical documents within project timelines.
• Familiar with US and international regulations for document preparation.
• Works with cross-functional teams on multiple projects.
• Requires 2+ years of experience in the bio-pharmaceutical industry.
• Outstanding communication skills are essential.

Requirements

• Bachelor's Degree in a scientific discipline.
• 2+ years of experience in a global pharma or biotech setting.
• Knowledge of medical and scientific terminology.
• Experience writing clinical documents following regulatory guidelines.
• Strong organizational and time management skills.
• Ability to analyze complex data effectively.
• Excellent writing and communication skills.
• Ability to collaborate with cross-functional teams.
• Advanced understanding of drug development and clinical research.
• Problem-solving skills are essential.

Benefits

• Comprehensive benefits package including paid time off.
• Medical, dental, and vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term incentive programs.