We’re looking for the best around. Are you interested?
CE is a provider of top-quality regulatory writing services looking for experienced writers/reviewers/MIS experts to join our team. Members of the CE team enjoy support from our project managers and support staff and ongoing training programs to keep them up-to-date on the latest regulatory guidelines.
Scientific Regulatory Writer
At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed flexibility, and budget control. Be on the leading edge by applying your regulatory writing expertise to a variety of projects with top industry clients.
Criterion Edge (CE) is seeking a remote contractor for the Scientific Regulatory Writer role. The position is responsible for providing writing expertise for a variety of regulatory documents that support the overall global regulatory submission requirements for the client’s portfolio of pharmaceutical, biotech or medical device products throughout the life-cycle.
Specific Responsibilities Include:
- Write clinical documents (e.g., Investigator’s Brochure/ Instructions for Use, Clinical Study Reports, protocols, manuscripts, poster and slide presentations) for submission to US and global regulatory authorities
- Serve as the medical writer on assigned projects, collaborating with the CE Scientific Quality Manager to meet all project deliverable timelines
- Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates and document content adheres to FDA/EMA or other applicable regulatory guidelines
- Previous experience writing regulatory reports and related documents in accordance with applicable global regulatory guidelines
- Effective written, verbal and presentation skills in the area of technical/clinical applications
- Strong command of medical and surgical terminology
- Demonstrated ability to identify and adapt to shifting priorities and competing demands
- Proficiency in document development and management using Word, Excel, PowerPoint and EndNote
- Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics
Email your resume/CV and a cover letter to: firstname.lastname@example.org.