Senior Medical Writer - Remote

Overview

As the Senior Medical Writer, you will author and make key contributions to clinical and regulatory documents within our organization, supporting our clinical studies.

In Short

• Author clinical study protocols, amendments, and other supporting documents.
• Co-author protocols and IBs with cross-functional SMEs.
• Author CSRs and data summaries for regulatory submissions.
• Identify risks and contribute to risk mitigation planning.
• Advocate for best practices in Medical Writing.
• Coordinate the finalization and publication of documents.
• Maintain document templates and identify process improvement opportunities.
• Work in a fast-paced, dynamic environment.
• Collaborate with cross-functional teams.
• Support professional development opportunities.

Requirements

• Bachelor's degree in a scientific discipline; advanced degree is a plus.
• 4+ years of regulatory medical writing experience.
• Strong knowledge of global pharmaceutical regulations.
• Excellent leadership and communication skills.
• Strong problem-solving and critical thinking abilities.
• Ability to meet deadlines and adapt to changing priorities.
• Proficiency in word processing software and document management systems.

Benefits

• Market competitive compensation and benefits package.
• Unlimited PTO.
• Two company-wide shutdowns each year.
• Commitment to professional development opportunities.
• Remote working environment with in-person meetings.