Remote Senior Drug Combination Clinical Regulatory Writer

Job Summary

An engineering and project management company is seeking a Remote Senior Drug Combination Clinical Regulatory Writer.

Individual must be able to fulfill the following responsibilities:

• Author documents per client specifications, templates, style guides, and other guidance documents
• Work closely with client and internal organization teams to develop and prepare regulatory documents
• Author documents per regulatory authority guidelines and requirements

Position Requirements Include:

• Bachelor's degree
• 8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD
• Understand regulatory authority guidelines and requirements
• Experience in the development of submission-level documents
• Intermediate proficiency with Microsoft Word skills
• Experience with using reference manager software and eCTD formatting