Why join Stryker?

　　We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

　　Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

　　We are currently seeking a Senior Staff Medical Writer to join the Clinical Affairs, Spine Division, with the flexibility of Remote or hybrid work arrangements.

　　Who We Want

　　Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

　　What you will do

　　As a Senior Staff Medical Writer, you will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, Summary of Safety and Clinical Performance and Clinical Study documents.

　　Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.Responsible for the development and completion of Clinical Evaluation Reports (CERs), PMCFs, and SSCPs for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.Collaborate cross-functionally to provide input for design teams for Clinical EU MDR documentation.Work in a cross-functional team to author clinical study protocols and reports, data summaries from raw data and document strategies.Prepare literature searches for drafting document content. Interprets literature information and synthesizes the information in clinical regulatory documents.For all documents, coordinates and manages the review process, and leads discussions on document revision.Challenge conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.Assist in the development of internal procedures, templates and style guides.Serve as a subject matter expert within department.Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve.Assist in the creation and maintenance of the Stryker Spine library for all relevant literature.Assist in the process improvements for the medical writing team.

　　What you need

　　A Bachelor's Degree required; preferably in a Scientific Discipline.A Master of Science Degree/ advanced degree in a Scientific Discipline preferred.A minimum of 7+ years of experience in healthcare products or medical devices.A minimum 6 years of experience in an FDA or highly regulated industry required; preferably with medical devices.Previous medical writing experience in a Healthcare Product or Medical Device industry required.Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations preferred.Strong scientific and medical writing skills required.Must be able to think analytically, can interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document.Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred.Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation preferred.

　　$95,100 - 176,900 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

　　About Stryker

　　Our benefits:

　　12 paid holidays annually Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

　　For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

　　About Stryker

　　Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

　　Know someone at Stryker?

　　Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

　　Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.