TF
Work Schedule
Other
Environmental Conditions
Office
Job Description
Position Overview:
Provides high-quality regulatory medical writing for internal and external clients. Provides technical consultation and substantive advice on strategy, regulations, and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Essential Duties and Responsibilities (other duties may be assigned):
• Independently researches, writes, and edits peri-/post-approval clinical study reports, study protocols, informed consent forms, and other peri-/post-approval regulatory documents. May support complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, and CTDs.
• Manages all aspects of planning, organizing, a ...