Senior Medical Writer

Everest Clinical Research

About The Position

Everest Clinical Research is seeking a committed, skilled, and customer-focused Senior Medical Writer to join its team. The role may be performed on-site in Toronto/Markham, Ontario, or remotely from a home-based office anywhere in Canada under Everest’s Work from Home policy. The Senior Medical Writer authors accurate, succinct clinical and regulatory documents supporting clinical trial activities and regulatory submissions, including clinical trial authorizations and marketing authorization applications. The role leads assigned writing projects from initiation through closeout, serves as the primary contact between Everest’s medical writing team and the sponsor, and helps ensure quality deliverables and timely project completion. The Senior Medical Writer develops document shells and drafts using approved templates and applicable writing styles; interprets study plans and results using background materials and statistical output; edits documents; coordinates internal and sponsor reviews; incorporates comments; follows up on quality control findings; and finalizes documents for sponsor delivery. The role also coordinates with document publishers, monitors project progress, identifies risks to quality and timelines, schedules reviews, and conducts peer and quality control reviews of work produced by other Medical Writers. The position contributes to medical writing standards, SOPs, guidelines, and good working practices; maintains current training on Everest guidance documents and regulatory or ICH requirements; and plans and carries out professional development.

Requirements

Advanced degree in Clinical, Medical, or Life Sciences; a Ph.D. is preferred, or a Master’s degree with substantial experience in the subject matter.
At least 5 years of experience in medical writing practice, including experience in the pharmaceutical clinical trial environment.
Experience preparing or authoring medical writing documents for clinical and regulatory purposes, including briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, CSRs, DSURs or annual reports, and IBs.
Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports.
Ability to understand medical information and results and communicate effectively, orally and in writing.
Ability to handle multiple projects and clients.
Excellent interpersonal and teamwork skills; detail-oriented, customer-focused, and quality-focused.
Well organized and able to work independently.
Comprehensive skills in MS Office applications and Adobe Acrobat.

Nice To Haves

Ph.D. in Clinical, Medical, or Life Sciences.
Experience preparing or authoring documents to support regulatory submissions, including clinical trial authorizations and marketing authorization applications.
Experience across multiple therapeutic areas and Phase I through IV clinical trials.
Excellent understanding of clinical trials and common clinical trial statistical analysis methods.

Responsibilities

Author accurate and succinct clinical and regulatory documents supporting clinical trial activities and regulatory submissions.
Develop initial document shells or drafts using appropriate approved templates and Everest or sponsor writing styles and formats.
Interpret study plans and results using background materials and statistical analysis output.
Edit medical and scientific writing products before internal and external review when time permits.
Obtain and incorporate internal and sponsor review comments, deliver revised drafts for further review, and follow up on quality control findings.
Finalize documents for sponsor delivery according to established timelines.
Coordinate with Everest or sponsor Document Publishers to meet document publishing requirements and timelines.
Lead assigned writing projects from initiation through closeout.
Act as the primary contact between the Everest medical writing team and the sponsor, supporting client relationships and quality deliverables.
Monitor and report project progress and proactively identify issues that may affect quality or timelines.
Schedule document reviews with appropriate internal reviewers.
Perform peer and quality control reviews of documents developed by other Medical Writers and provide feedback to support their learning.
Contribute to the development and maintenance of medical writing standards, SOPs, guidelines, and good working practices.
Keep current on Everest Guidance Documents and general requirements or guidelines issued by pharmaceutical drug trial regulators and ICH.
Plan and carry out professional development.