[Hiring] Senior 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 Senior 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.

• Author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, etc., and clinical trial activities.
• Documents include but are not limited to:
  • Briefing packages
  • Regulatory summaries
  • Integrated Summaries of Safety and Efficacy
  • Clinical study protocols
  • Clinical Study Reports (CSRs; full, abbreviated, or synoptic)
  • Development Safety Update Reports (DSURs)/annual reports
  • Investigator’s Brochures (IBs)
• Develop initial document shells or drafts using appropriate and approved templates and adhering to Everest or sponsor’s writing styles and formats.
• Provide appropriate and accurate interpretation of study plans and 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 and scientific writing products to refine them, as much as possible and when time permits, before releasing them for internal and external review.
• Follow the Everest governing documents to obtain review comments on the document drafts from internal (Everest team) and external (sponsor staff) reviewers.
• Incorporate reviewers’ comments/input into the draft documents and deliver the revised documents for additional review cycle(s).
• Follow up on the quality control (QC) findings until they are properly addressed.
• Finalize documents for delivery to sponsors according to the established timelines.
• Interact with Everest or sponsor Document Publishers for the document publishing of the medical and scientific writing project.
• Lead assigned writing projects from initiation to close out of the project.
• Act as the primary contact between Everest medical writing team and the sponsor, focusing on client relationship management and quality deliverables.
• Monitor and report on project progress and proactively identify issues or factors that potentially will impact the quality and timeliness of the medical writing projects.
• Schedule document reviews by appropriate internal reviewers.
• Perform peer and quality control review for documents developed by other Medical Writers.
• Contribute to the development and maintenance of standards for medical writing through participation in the development of related SOPs, guidelines, and good working practices.
• Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.
• Plan and carry out professional development.

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 5 years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment.
• Experience with preparing/authoring documents to support regulatory submissions including clinical trial authorizations and marketing authorization applications (preferred).
• Experience with medical writing of clinical and regulatory documents including:
  • Briefing packages
  • Regulatory summaries
  • Integrated Summaries of Safety and Efficacy
  • Clinical study protocols
  • CSRs
  • DSURs/annual reports
  • IBs
• 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 MS Office applications and Adobe Acrobat.

Benefits

• Robust benefits package to support your health, well-being, and growth, including:
  • 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
• Estimated Salary Range: $90,000 - $140,000.