Lead R&D Technical Writer

Job Summary

Working remotely on a contract basis, the Lead R&D Technical Writer will independently manage clinical and regulatory documentation efforts, influence documentation standards, and collaborate across teams to ensure timely, high-quality submissions.

Key responsibilities

• Assist in the development and completion of clinical reports, summary documents, and package inserts
• Oversee the electronic regulatory submission process and recommend formats and guidelines for documentation
• Ensure effective planning and management of timelines for all technical documents

Required qualifications

• Minimum of 4 years' relevant work experience
• College degree or equivalent required
• Professional mastery of a specialized field of expertise
• Experience in clinical or pre-clinical documentation preferred
• Knowledge of electronic regulatory submission processes is a plus