Senior Medical Writer

Everest Clinical Research (“Everest”) is a full‑service contract research organization (CRO) that provides a broad range of expertise‑based clinical research services to pharmaceutical, biotechnology, and medical device industries. We serve some of the best‑known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. We are seeking a committed, skilled, and customer‑focused individual to join our team as a Senior Medical Writer for our Toronto/Markham, Ontario, Canada on‑site location, or remotely from anywhere in Canada in accordance with our Work from Home policy. Key Accountabilities Author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, such as briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, CSRs, DSURs, and Investigator’s Brochures. Develop initial document shells or drafts using approved templates and adhering to Everest or sponsor writing styles. Interpret study plans and results based on provided background materials and statistical analysis output. Perform effective editing and incorporate reviewer comments to refine documents, ensuring quality and compliance with timelines. Interact with Everest or sponsor Document Publishers to ensure the final writing product meets publishing requirements. Lead assigned writing projects from initiation to close‑out, serving as the primary contact between the Everest medical writing team and the sponsor. Monitor and report project progress, proactively identifying issues that could impact quality and timeliness. Schedule document reviews by appropriate internal reviewers. Perform peer and quality control review for documents developed by other Medical Writers. Contribute to development and maintenance of standards for medical writing through SOPs and guidelines. Keep current on training and regulatory guidance, including ICH guidelines. Plan and carry out professional development. Qualifications and Experience Advanced degree (Ph.D. preferred) in Clinical, Medical or Life Sciences, or Master’s degree with substantial experience. At least 5 years of medical writing experience in the pharmaceutical clinical trial environment. Experience preparing or authoring documents to support regulatory submissions. Experience with briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, CSRs, DSURs, and IBs. Experience in multiple therapeutic areas and Phase I‑IV trials an asset. Excellent understanding of clinical trials and common statistical analysis methods. Strong written and verbal communication skills. Ability to handle multiple projects and clients. Excellent interpersonal and teamwork skills, detail‑oriented, customer and quality focused. Knowledge of GCP/ICH guidelines, including E3 content of CSRs. Well organized and able to work independently. Comprehensive skills in MS Office and Adobe Acrobat. Estimated Salary Range: $100,000 - $140,000. We thank all interested applicants; however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com. #J-18808-Ljbffr