Senior Staff Medical Writer (Remote) – Stryker

Job Description

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

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
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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 Senior Staff Medical Writer to join the Medical Affairs, Joint Replacement Division, with the flexibility of Remote or Hybrid work arrangements, located in Mahwah, New Jersey.

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. This position requires minimal supervision.

• Responsible for the development and completion of Clinical Evaluation Reports (CERs) and post market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
• Compiles 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 CERs, and annual updates.
• Addresses notified body feedback on EU clinical documents and leads them to resolution for continued EU market access of the products.
• Collaborates cross-functionally to provide input to design teams on Clinical EU MDR documentation, related strategies and timelines.
• Support Clinical Evaluation Strategy for EU Market access.
• Work in a cross-functional team to author clinical study protocols and reports, data summaries from raw data and document strategies.
• Supports manuscript writing.
• Performs systematic literature reviews for medical device groups or sub-groups. 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.
• Challenges conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.
• Assist in internal procedures, templates and style guide development and review.

• Leads process improvement for the better efficiency within the department and standardizing document creation process flow.
• Assist in the creation and maintenance of medical writing tools.
• Serve as a subject matter expert within department. Recognizes potential scheduling and resource conflicts for projects and provides recommendations to resolve.
• Mentors and may direct work of Medical Writer, Senior Medical Writer, or Staff Medical Writer.

What you need
• A bachelor’s degree required; preferably in a Scientific Discipline.
• A Master of Science Degree in a Scientific Discipline preferred.
• A minimum of 6 years of experience in healthcare products or medical devices.
• A minimum of 4 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 required.
• 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.

$114,000 – 188,800 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

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com