Regulatory Writer – Regulatory QC/Editor

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and refine a diverse array of regulatory documents.

• Conduct independent quality control reviews of documents generated by the regulatory writing team.

• Ensure the accuracy and internal/external consistency of documents.

• Establish and clarify the scope of quality control activities with document authors.

• Evaluate documents for compliance with relevant style guides.

• Review and copyedit text to guarantee clarity and precision.

• Assist in the preparation and readiness of technical documents for inspections.

• Clearly and constructively communicate quality control findings to stakeholders.

• Promote the effective management of individual document workflows throughout projects.

• Contribute to the ongoing enhancement of quality control tools, checklists, and processes.

⛳️ Requirements

• A Bachelor’s degree along with over 5 years of relevant experience.

• Proficient understanding of the industry and the content of essential eCTD documents.

• Knowledge of drug development and regulatory submission procedures.

• Exceptional attention to detail paired with strong analytical and critical-thinking capabilities.

• Demonstrated ability to handle multiple tasks and priorities in a fast-paced, deadline-oriented environment.

• Experience collaborating cross-functionally in team settings.

• Familiarity with electronic document management and publishing systems.

• Background in project and timeline management systems.

🏝️ Benefits

• Health insurance.

• Flexible work hours.

• Paid time off.