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Medical Writer

2 weeks ago

Toronto, Ontario, Canada Atlas Search Full time $90,000 - $120,000 per year

We are currently partnered with a global biopharmaceutical company that is seeking a Medical Writer (Senior / Principal) to enhance their dynamic team.

Our client is dedicated to a noble mission – the discovery, development, and commercialization of groundbreaking medicines aimed at addressing profound unmet medical needs in the fields of oncology, inflammation, and autoimmunity. Join us in this remarkable journey toward innovative solutions in healthcare.

Responsibilities:

  • Author accurate, clear, and concise documents to support regulatory submissions for clinical trial authorizations, marketing authorization applications, and related clinical trial activities. These 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, and Investigator's Brochures (IBs).
  • Develop initial document shells or drafts using approved templates and adhering to the sponsor's writing styles and formatting requirements.
  • Provide accurate interpretation of study plans and results based on background materials (e.g., study protocols, statistical analysis plans, Investigator's Brochures, and relevant literature) and statistical analysis outputs.
  • Perform thorough editing of assigned medical and scientific writing deliverables to refine and ensure quality before internal and external review. Obtain and incorporate review feedback from internal team members and sponsor reviewers.
  • Integrate reviewers' comments into document revisions and deliver updated versions for additional review cycles as needed. Address all quality control (QC) findings and finalize documents for submission to sponsors in accordance with established timelines.

Requirements:

  • 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 in multiple therapeutic areas and Phase I through IV clinical trials an asset (preferred).
  • Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports.