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Everest Clinical Research

Medical Writer

Everest Clinical Research

. Work closely with Everest project team members to achieve project milestones according to project timelines .

Posted 10/16/2026full-timeRemote • CanadaJuniorMid-Level💰 CA$65,000 - CA$100,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in medical writing for clinical documents and regulatory submissions, with a strong understanding of clinical trials and statistical analysis methods. Proficient in managing project timelines and deliverables while ensuring quality and compliance with GCP/ICH guidelines.

Highest-signal resume keywords
Medical WritingClinical Study ReportsGCP/ICH GuidelinesStatistical Analysis MethodsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Medical WritingClinical Study ReportsStatistical AnalysisLiterature SearchesDocument EditingQC ProceduresE-PublishingDocument DraftingRegulatory SubmissionTherapeutic Areas Knowledge
Soft Skills
Effective CommunicationInterpersonal SkillsDetail-OrientedTeamworkCustomer Focus
Tools & Technologies
Microsoft OfficeAdobe AcrobatTRS Toolbox Pharma Edition
Industry Keywords
Clinical TrialsPharmaceuticalsICH RequirementsGCP GuidelinesPhase I-IV Trials

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Work closely with Everest project team members to achieve project milestones according to project timelines
  • Perform internal QC procedures for clinical documents, including protocols, CSRs, PK reports, statistical reports, integrated summaries, patient narratives, manuscripts, posters, and abstracts
  • Check tables of contents, lists of tables and figures, abbreviations, protocol-related information, in-text numbers, source references, Word styles, quoted references, and appendices
  • Act as lead medical writer in preparing clinical documents and scientific publications
  • Develop document shells or drafts using approved templates and Everest or Sponsor writing styles
  • Interpret study results using protocols, statistical analysis plans, investigator brochures, literature references, and statistical outputs
  • Edit medical writing products before internal and external review
  • Obtain and incorporate internal and Sponsor review comments
  • Follow up on QC findings and finalize documents for Sponsor delivery
  • Perform literature searches to support senior medical writers
  • E-publish CSRs and other clinical/regulatory documents, including PDF rendering, hyperlinking, bookmarking, table-of-contents updates, and pagination
  • Assemble and package TLGs into Word and PDF formats
  • May serve as DMC Administrator or Secretary, coordinating charters, meetings, minutes, recommendations, committee liaison activities, members, agreements, honoraria, and data reports
  • Plan and manage deliverables and timelines
  • Maintain training on Everest Guidance Documents and pharmaceutical trial regulator and ICH requirements
  • Plan and carry out professional development

Requirements

What you’ll need
  • 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 an 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, customer- and quality-focused
  • Demonstrated experience, knowledge, and 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 an asset

Benefits

Comp & perks
  • medical, dental, and vision coverage
  • life & AD&D insurance
  • short- and long-term disability
  • tuition reimbursement
  • fitness reimbursement
  • employee assistance program (EAP)
  • a pension plan
  • generous paid time off and sick leave
  • opportunity to earn a performance based bonus