Medical Writer

About This Role

This role involves preparing and quality-checking clinical documents and scientific publications for pharmaceutical, biotechnology, and medical device industries. The Medical Writer will work closely with project teams to meet milestones and ensure high-quality deliverables, applying therapeutic area experience and scientific knowledge.

Responsibilities

• Work closely with Everest project team members to achieve project milestones according to the project timeline
• Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as clinical study protocols, Clinical Study Reports (CSRs; full, abbreviated, or synoptic), pharmacokinetic (PK) reports, statistical reports, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts
• Apply therapeutic area experience and scientific knowledge in the review and include QC checks for protocol-related information, accuracy of in-text numbers and source references, and consistency of document styles and formats
• Check the accuracy of the Table of Contents (TOC) compared to the headings within the report and ensure proper alignment of TOC styles within the TOC
• Check the accuracy of any List of Tables or List of Figures compared to the in-text tables and figures
• Check the accuracy and completeness of abbreviations within the List of Abbreviations compared to in-text abbreviations used in the report and abbreviations used in the statistical tables, listings, and graphs (TLGs)
• Verify that protocol-related information is accurately and consistently applied to the text of the report, including study objectives, study design, primary and secondary endpoints, treatments and procedures, and adverse event reporting procedures
• Check the accuracy of numbers within in-text tables and report text against the source data (e.g., TLGs)
• Verify the accuracy of references to the source tables and listings
• Ensure that Word styles are consistently applied throughout the document
• Verify the accuracy of quoted references in the report
• Check the accuracy of a list of appendices in a report compared to the final appendices produced for the report
• Act as a lead medical writer in the preparation of clinical documents or scientific publications
• Develop initial document shells or drafts using appropriate and approved templates and adhering to Everest or Sponsor's writing styles and formats, with proper medical and study disease area experience
• Provide appropriate and accurate interpretation of study results based on the provided background materials (e.g., study protocol, Statistical Analysis Plan, Investigator's Brochure, literature references) and statistical analysis output
• Perform effective editing on assigned medical writing products to refine them, as much as possible and when time permits, before releasing them for internal and external review