Why join Stryker?

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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 Staff Medical Writer to join our Spine Division. This role will be based remotely anywhere in the United States.

Who we want

• Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.

• 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.

• Communicators. Articulates well and expresses ideas effectively.

• Learners. Great desire to learn and looks to continuously improve.

• Teammates . Supports, encourages, and inspires others.

What you will do

As the Staff Medical Writer , you will be responsible for creating clear, accurate, and regulatory-compliant documentation related to clinical submissions. Your primary role involves translating complex scientific and technical information into accessible content for various audiences, including regulatory bodies. 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 plans and reports (CEPs/CERs), Post Market Clinical Follow-up (PMCF) documents, and Summary of Safety and Clinical Performance (SSPCs) 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 CEPs and CERs, PMCF Plans and Reports, and SSCPs for new and existing medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing documents.

• Collaborate cross-functionally to provide input for design teams for Medical Affairs EU MDR documentation.

• Work in a cross-functional teams to support clinical study protocols and reports, data summaries from raw data, and document strategies.

• Prepare literature searches for drafting document content, interpret literature information, and synthesize the information in clinical regulatory documents.

• For all documents, coordinate and manage the review process, and lead discussions on document revision.

• Challenge conclusions, when necessary, independently resolve document content issues and questions from external and internal reviewers, and ensure timely approvals from all reviewers.

• Assist in the development of internal procedures, templates, and style guides.

• May serve as a subject matter expert within department.

• Recognize potential scheduling and resource conflicts for projects and provide 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

• B.A. or B.S. Degree required, preferably in a technical or scientific discipline.

• Master's or advanced degree in health-related field preferred.

• 4+ years of industry experience in medical technology or pharma or relevant academic or clinical research experience (PhD, Post-doc) required.

• 2+ years of experience in Scientific or Medical Writing or relevant academic or clinical research experience required.

• Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software

• Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents.

$85,500 - $184,000 salary plus bonus eligible + benefits. 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 (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)

About Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, 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. (http:)

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 (https://careers.stryker.com/referrals/)

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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.