Senior Regulatory Writer - Remote

Overview

The Senior Regulatory Writer is responsible for writing, reviewing, and managing high-quality clinical and safety documentation for regulatory submissions, while also providing consultancy and mentorship to less experienced writers.

In Short

• Author and manage clinical and safety documents for regulatory submissions.
• Core member of Clinical Trial Teams and Safety Management Teams.
• Contribute to planning of data analyses and presentations.
• Ensure compliance with internal standards and external regulatory guidelines.
• Provide content expertise for clinical portions of submissions.
• Lead writer for simple submissions, ensuring messaging consistency.
• Coach and mentor less experienced writers.
• Participate in process improvement initiatives.
• Maintain compliance with audit and training standards.
• Communicate effectively across functions to enhance document quality.

Requirements

• Minimum university life science degree or equivalent required.
• Advanced degree in life sciences/healthcare desirable.
• 4+ years of medical writing or relevant pharma experience.
• In-depth knowledge of medical writing processes.
• Advanced knowledge of global regulatory environments.
• Excellent communication skills (written and verbal).
• Strong prioritization and project management skills.

Benefits

• Competitive salary and potential for bonuses and stock options.
• Comprehensive medical and financial benefits.
• 401(k) eligibility with various paid time off benefits.
• Opportunities for professional development and growth.