Principal Medical Writer

About

Take charge as a Principal Medical Writer to create foundational regulatory submission documents. Utilize your scientific expertise to drive clarity and accuracy in vital medical communications.

In this pivotal role, you’ll manage medical writing activities for individual studies, coordinating tasks seamlessly across departments. With experience in clinical research and regulatory standards, you will prepare a range of essential documents, including protocols, reports, and submissions. Your skills will ensure compliance and excellence in presentation across the board.

Responsibilities

• Lead development of regulatory submission documents
• Manage cross-departmental medical writing activities
• Prepare diverse clinical documents and reports
• Ensure adherence to regulatory and style guidelines
• Review statistical analysis plans for accuracy

Requirements

• Bachelor's degree with writing experience; graduate degree preferred
• 3-5 years in science or medical writing
• Strong understanding of FDA and ICH regulations
• Proven track record of relevant document types
• Excellent command of English grammar and AMA style

Elevate your career by applying your writing prowess in a crucial medical field, shaping impactful regulatory submissions with accuracy and integrity.