Senior Medical Writer - Remote

Overview

The Senior Medical Writer will critically evaluate, analyze, and interpret medical literature to support the pharmaceutical, biotech, and medical device industries in creating compelling submissions that meet rigorous regulatory standards.

In Short

• Write and edit clinical development documents.
• Maintain timelines and workflow of writing assignments.
• Practice good internal and external customer service.
• Interact directly with clients to coordinate projects.
• Mentor medical writers and project team members.
• Expert proficiency with client templates and style guides.
• Complete writing assignments in a timely manner.
• Contribute to the production of interpretive guides.
• Take ownership of assignments and consult with team members.
• Highly proficient in writing styles for regulatory documents.

Requirements

• 3-5 years of regulatory writing and clinical medical writing experience.
• Bachelors, Masters, or Ph.D. in a scientific or medical discipline.
• Substantial clinical study protocol experience as lead author.
• Exceptional writing and organizational skills.
• Expert in MS Word, Excel, and PowerPoint.
• Experience leading and managing project teams.
• Strong understanding of federal regulations and Good Clinical Practices.
• Experience with orphan drug designations is a plus.

Benefits

• Work with a leading CRO recognized for customer satisfaction.
• Opportunity to contribute to significant regulatory submissions.
• Mentorship opportunities within the project team.
• Engage in a data-driven approach to drug development.