principal medical writer - regulatory

Summary: The Principal Regulatory Medical Writer is a technical expert tasked with authoring and coordinating high-quality, submission-ready documents that align with global regulatory requirements. This role uniquely combines clinical data analysis with regulatory standards to ensure compliance in clinical study reports, protocols, and summary documents. The position is remote and emphasizes the importance of meeting rigorous health authority standards.

Key Responsibilities:

• Author and coordinate high-quality, submission-ready regulatory documents.
• Ensure compliance with global regulatory requirements for clinical study reports and protocols.
• Maintain rigorous standards set by global health authorities.
• Collaborate with clinical teams to integrate data into regulatory submissions.

Key Skills:

• Expertise in regulatory writing and clinical documentation.
• Strong understanding of global regulatory requirements.
• Excellent communication and collaboration skills.
• Ability to analyze and interpret clinical data.

Salary (Rate): £70 per hour

City: Whitehouse Station

Country: United States

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other