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Senior Staff Medical Writer (Remote)

Stryker

62d ago

0$110k - $238kWritingDenver, CO, USjobspy_indeed
remoteindeed

Job Description

### **Why join Stryker?** Looking for a place that values your unique talents? Discover Stryker's award\-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.### **Job description** We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. Stryker is hiring a **Senior Staff Medical Writer** to join our **Endoscopy** Division, to be based remotely anywhere within the United States. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. Our Endoscopy Division delivers a diverse array of innovative medical technologies to support minimal invasive surgery through brilliant visualization, connected OR solutions, sports medicine products to sustainability solutions. As the **Senior Staff Medical Writer**, you will develop scientific and clinical documentation that supports global regulatory compliance and market access for medical devices. This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research \& Development, and Marketing teams to translate complex clinical evidence into high\-quality regulatory and scientific documents throughout the product lifecycle. **What You Will Do** * 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. * Collaborate 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. **What You Need** **Required** * Bachelor’s degree in a scientific, technical, healthcare,