Medical Writer

Overview

Join to apply for the Medical Writer role at Everest Clinical Research.

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. 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.

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

• Work closely with the Everest project team members assigned to the project 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, CSRs (full, abbreviated, or synoptic), 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. QC procedures include, but are not limited to, the following: checking the accuracy of the Table of Contents (TOC) relative to headings, List of Tables/Figures, List of Abbreviations relative to in-text abbreviations, verification that protocol-related information is consistently applied, ensuring accuracy of numbers in in-text tables and text against source data, verifying references, ensuring consistent Word styles, verifying quoted references, and checking the list of appendices against final appendices.
• Act as a lead medical writer in the preparation of clinical documents or scientific publications, including developing initial document shells or drafts using approved templates and adhering to Everest or Sponsor writing styles and formats; providing interpretation of study results; performing editing to refine documents before review; and ensuring QC checks are performed and reviewer comments are addressed before delivery to Sponsors according to established timelines.
• Perform literature searches to support senior medical writers.
• Perform document e-publishing for CSRs and other clinical/regulatory documents to meet publishing requirements and timelines (rendering Word reports to PDF, acquiring documents, applying Everest standards, creating hyperlinks and bookmarks, updating the table of contents and final pagination).
• Perform timely completion of TLG (Tables, Listings, Figures) assembly packaging into Word and PDF format for other departmental teams. May perform a lead role in providing these services.
• May serve as the DMC Administrator and/or DMC Secretary and perform hands-on administrative tasks for assigned projects, including writing committee charters, liaison responsibilities, planning and coordinating meetings, producing minutes, assisting with recommendations letters, and coordinating the preparation of Data Reports by internal or external teams.
• Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
• Keep current on Everest Guidance Documents and on general regulatory guidelines issued by pharmaceutical drug trial regulators and ICH.
• Plan and carry out professional development.

Qualifications and Experience

• Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• At least two years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment.
• Experience with medical writing for clinical study reports for regulatory submission (preferred).
• Experience in multiple therapeutic areas and Phase I through IV clinical trials (asset preferred).
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred).
• Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.
• Ability to handle multiple projects and clients; excellent interpersonal and teamwork skills; detail-oriented and customer- and quality-focused.
• Demonstrated understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports.
• Well organized and able to work independently.
• Comprehensive skills in Microsoft Office applications and Adobe Acrobat; computing skills with TRS Toolbox pharma edition plugin (asset).

We thank all interested applicants; however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and accommodations can be provided upon request during the recruitment process.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Marketing, Public Relations, and Writing/Editing

Industries

• Research Services, Pharmaceutical Manufacturing, and Hospitals and Health Care

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