Principal Medical Writer

Job Summary

Leading the development of regulatory documents, the full-time Principal Medical Writer will independently plan, prepare, and author nonclinical submissions while collaborating with cross-functional teams in a remote environment.

Key responsibilities:

• Lead project teams in the development and writing of high-quality regulatory documents, including study-level and submission-level documents
• Act as a client advisor, building strong relationships through effective communication and collaboration
• Manage project budgets and oversee the document review process, ensuring compliance with regulatory guidelines and company standards

Required qualifications:

• Bachelor's degree; MS or PhD preferred
• 7+ years of regulatory writing experience, particularly with nonclinical sections of the CTD
• Strong understanding of regulatory authority guidelines and the drug development lifecycle
• Experience in developing submission-level documents
• Intermediate proficiency in Microsoft Word and document management techniques