Responsible for writing Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), as well as a variety of other regulatory documents including, but not limited to, Investigational New Drug Applications (INDs) and New Drug Applications (NDAs), manuscripts, and/or poster, slide, or oral presentations.
- Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
- Writes Integrated Summaries of Safety and Efficacy (ISS and ISE), New Drug Applications (NDAs) and other regulatory documents necessary for regulatory submission
- Writes and develops manuscripts and/or posters for publication
- Creates slides for oral presentations
- Creates in-text tables and word processing
- Compiles document appendices, attachments, etc.
- Reviews draft case report forms (CRFs), statistical analysis plans (SAPs), and blinded data listing reviews prior to database lock and provides feedback to the team when appropriate
- Reviews documents generated by other medical writers in the department and provides constructive feedback (editing as needed)
- Conducts background research as necessary for each assigned project, including literature searches
- Works on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and sponsors
- Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
- Interprets and trains other staff members regarding current regulatory guidelines pertaining to regulatory documents
- Interprets scientific literature
- Ensures timeline adherence for each assigned project
- Facilitates a team approach for each assigned project
- Provides project status updates on a regular basis
- Carries out contractual obligations for each assigned project based on the sponsor proposal
- Demonstrates an understanding of experimental methods and research design
- Attends meetings (proposal, kickoff, etc.) with prospective sponsors when necessary
- Takes the lead for writing complicated assignments
- Assists in the creation of study templates, review forms, and guidance documents
- 6+ years experience in medical/technical writing
- 4+ years experience in medical/technical writing if PhD
- Experience with medical device-related documentation and regulation is preferred.
- This is a remote-based as-needed contract position.
Education (Degree) or certifications:
- Bachelor’s degree in the medical sciences, journalism, or English (MS or PhD preferred)