Position OverviewThe Senior Medical Writer (MW) will lead the development of high‑quality, on‑time clinical study documents, ensuring compliance with Precision MW Style Guide, SOPs, regulatory guidelines (ICH, FDA, GCP) and eCTD requirements.ResponsibilitiesPlanning, writing, editing, formatting, and QC review of timely and high‑quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidancesEnsures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departmentsAbility to independently formulate key messages from clinical study dataAbility to author complex content using knowledge/skills and understanding of processesAbility to communicate clearly and concisely both in writing and verbally with internal and client teamsContributes to the development and maintenance of medical writing processes, SOPs, templates,



and work instructions for key documentsExcellent problem‑solving skillsPerforming literature‑based research to support writing activitiesOther duties as assignedQualificationsBS degree or equivalent in a scientific or medical discipline with relevant writing expertise5+ years of experience as a medical writer in the sponsor and/or CRO settingOther RequirementsProficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPointClear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.Gov), and eCTD requirements for all phases of developmentImpeccable attention to detail and ability to complete writing assignments in a timely mannerAbility to work effectively in a fast‑paced environment with multiple high‑priority projects with minimal instruction on routine work and new assignmentsPreferredAdvanced degree (MS/PhD)Oncology and/or rare disease experience (especially protocol and CSR development)CompensationSalary Range: $101,800 - $152,600Equal Prospect EmployerPrecision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.#J-18808-Ljbffr

📌 Senior Medical Writer - $101,800 - $152,600 A Year (Winnipeg)
🏢 Precision Medicine Group
📍 Winnipeg