Leading document authorship for various clinical projects, the full-time Senior Medical Writer will work remotely, interfacing with clients and supporting larger engagements while leveraging expertise in clinical regulatory writing.
Key responsibilities
- Serve as the project lead on smaller projects and support larger, complex engagements as part of a delivery team
- Develop submission-level documents and clinical documents such as Clinical Study Reports and Investigator Brochures
- Interface directly with clients to understand their needs and ensure compliance with regulatory authority guidelines
Required qualifications
- Bachelor''s degree or higher in a scientific discipline strongly preferred
- 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation
- Understanding of regulatory authority guidelines and their impact on document creation
- Experience developing clinical documents, including protocols and submission-level documents
- Intermediate proficiency with Microsoft Word and document management techniques