Hiring: Senior Staff Medical Writer (Remote) Company: Stryker Location: Portland, OR Job Posted Time: 2026-09-03 11:19:12 Target Skills & Keywords : Clinical Documentation, GCP, Regulatory Compliance, Risk Management About the job Experience: •6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products. •4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities. •Minimum 6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products. •Minimum 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities. Required Skills: •Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management. •Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post-market data, and other safety and performance sources into submission-ready regulatory documents. •Respond to notified body reviews and regulatory feedback, driving resolution of clinical documentation questions to support ongoing market access. •Partner cross-functionally with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines. •Author clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives. •Conduct systematic literature reviews, evaluate scientific data, and integrate findings into clinical and regulatory documentation. •Lead document review cycles, coordinate stakeholder feedback, resolve content issues, and obtain timely approvals. •Drive continuous improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members. Qualifications: •Master’s degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-related degree. •Knowledge of clinical operations, risk management, and international regulatory requirements. •Posted Date: 08/17/2026 This role will be posted for a minimum of 3 days. •View the U.S. work location and transparency guide to find the pay range for your location. Compensation: •$110,100 - $183,400 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!