The Medical Writing Specialist is responsible for the tracking, quality control and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents.
Some responsibilities include:
-Working together with key interface partners (e.g. Study Management, Statistics and Programming) to facilitate the completion of clinical study reports and their appendices. Using project management skills to track, review and ensure timely completion of high quality regulatory documents
-Checking that study file components (e.g., Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements.
-Acting as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guides to reflect new agreements and changes due to SOPs and regulatory guidelines.
-Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent.
-Performing real-time edits to clinical documents during comment review and resolution meetings.
-Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation and electronic publishing.
-Managing the review and approval of documents in the document management system using standard procedures.
Requirements:
1. Bachelor's or Associates degree with strong electronic documentation and word processing skills.
2. Excellence in written and oral communication skills in English.
3. Excellent interpersonal skills.
4. Familiarity with clinical research, statistics, and regulatory submission requirements preferred.
