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. 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 - 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, to ensure that the final writing product will meet specific document publishing requirements and timelines. - 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, with a focus 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, applying medical and scientific writing experience as well as therapeutic area and scientific knowledge in the review. - 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.

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. - 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 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. Computing skills with TRS Toolbox pharma edition plugin an asset. Requirements - Strong foundation in statistical and data management. - Ability to perform effective editing on assigned medical writing products. - Experience in performing QC checks on medical writing deliverables. - Ability to incorporate reviewers’ comments/input into draft documents. - Experience in finalizing documents for delivery to Sponsors according to established timelines. Benefits - Robust benefits package 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.

• Review and evaluate medical record documentation for completeness, accuracy, and compliance. • Collaborate with physicians, nurses, and coding professionals to ensure appropriate clinical documentation. • Identify opportunities for documentation improvement to support coding accuracy, reimbursement, and clinical outcomes. • Analyze medical records to ensure documentation supports quality care and appropriate reimbursement. • Formulate compliant, clinically sound physician queries.

• Use clinical and coding knowledge for conducting clinically based concurrent and retrospective reviews of inpatient medical records • Evaluate the documentation of clinical services by identifying opportunities for improving the quality of medical record documentation • Facilitate and obtain appropriate physician documentation for clinical conditions or procedures • Participate in ongoing documentation improvement initiatives