Senior Clinical Medical Writer

Job Summary

Leading document authorship for various clinical regulatory projects, the full-time Senior Clinical Medical Writer will work remotely, managing smaller projects directly with clients while supporting larger engagements as part of a delivery team.

Key responsibilities

• Author and lead the development of clinical regulatory documents, including Clinical Study Reports and Investigator Brochures
• Interface directly with clients on smaller projects and collaborate with larger teams on complex engagements
• Ensure compliance with regulatory authority guidelines and anticipate the impact of writing conventions on submission outcomes

Required qualifications

• Bachelor's degree in a relevant field
• 3+ years of regulatory writing experience or equivalent clinical documentation experience
• Understanding of regulatory authority guidelines and the drug development lifecycle
• Experience in developing submission-level documents, such as protocols and integrated summaries
• Intermediate proficiency in Microsoft Word and document management techniques