[Hiring] Medical Writer @Everest Clinical Research

Role Description

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.

• 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
  • 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
  • Consistency of document styles and formats
• Act as a lead medical writer in the preparation of clinical documents or scientific publications.
• Perform literature searches to support senior medical writers.
• Perform document e-publishing for CSRs and other clinical/regulatory documents.
• Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

Qualifications

• 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.

Requirements

• Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines.
• Ability to handle multiple projects and clients.
• Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.

Benefits

• Medical, dental, and vision coverage
• Life & AD&D insurance
• Short- and long-term disability
• Tuition reimbursement
• Fitness reimbursement
• Employee assistance program (EAP)
• Pension plan
• Generous paid time off and sick leave
• Opportunity to earn a performance-based bonus