Job Summary
A staffing company has an open position for a Telecommuting Clinical and Regulatory Document Contract Medical Writer.
Core Responsibilities Include:
- Ensuring that all clinical study and submission documents for projects are prepared, reviewed, and approved in a timely manner
- Write Clinical Study Reports and CSRs
- Create safety updates and regulatory submissions (eCTD modules 2.5 and 2.7)
Applicants must meet the following qualifications:
- Contractor will be requested to attend required meetings in Northern, NJ
- Must have at least 5-7 years of experience with "hands-on" experience writing the below clinical/regulatory documents
- Experience with clinical trial registry and disclosure activities
- Thorough understanding of GCP and ICH guidelines
- Able to prioritize and self-manage
- Knowledge of summary level documents