Medical Writer
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Medical Writer for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.
Key Accountabilities:
QC procedures include, but are not limited to, the following:
Checking the accuracy of the Table of Contents (TOC) compared to the headings within the report and ensuring proper alignment of TOC styles within the TOC. Similarly, checking the accuracy of any List of Tables or List of Figures compared to the in-text tables and figures. Checking 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).
Verifying that protocol-related information is accurately and consistently applied to the text of the report. Such protocol information includes: study objectives, study design, primary and secondary endpoints, treatments and procedures, and adverse event reporting procedures. Checking 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.
Ensuring that Word styles are consistently applied throughout the document. Verifying the accuracy of quoted references in the report. Checking the accuracy of a list of appendices in a report compared to the final appendices produced for the report.
With proper medical and study disease area experience, developing initial document shells or drafts using appropriate and approved templates and adhering to Everest or Sponsor’s writing styles and formats. Providing 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…
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