Principal Medical Writer, Global Medical Writing - Remote

Overview

This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science that continuously evolves with new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs.

In Short

• Lead medical writing for clinical programs.
• Manage and author clinical study-related documents.
• Participate in NDA/MAA/IND submission planning.
• Maintain knowledge of current developments in medical writing.
• Incorporate process improvements aligned with R&D needs.
• Mentor junior medical writers.
• Perform reviews of medical writing deliverables.
• Strong organizational skills for managing multiple documents.
• Experience in oncology, immunology, or neurology preferred.
• Excellent written and verbal communication skills.

Requirements

• Advanced degree (MS or Ph.D.) in a relevant field.
• 5-8 years of medical writing experience.
• Expert knowledge in preparing clinical and regulatory documents.
• Knowledge of clinical trial disclosure.
• Submission experience across ICH regions.
• Proficiency with eCTD Starting Point templates and MS Office.
• Strong attention to detail and organizational skills.
• Ability to manage multiple concurrent projects.
• Experience in performing medical literature searches.
• Team player with strong collaborative skills.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Opportunities for personal and professional growth.