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
