We are currently seeking a Senior Staff Medical Writer to join our Division to be based in San Jose, CA or remotely anywhere within the United States.

Who we want

* Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

* Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

* Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

What you will do

As the 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.

• Complies 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.

• Coordinates and manages the review process, and leads discussions on document revision.

• Challenge conclusions when necessary. Independently resolve 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.

• Lead process improvement for better efficiency within department, standardizing document creation process flow.

• Assist in the creation and maintenance of the Stryker Endoscopy medical writing tools.

• Serve as a subject matter expert within department. Recognizes potential scheduling and resource conflicts for projects and provides recommendations to resolve.

• Mentor Medical Writer or Senior Medical Writer.

What you need

• Bachelors Degree required; preferably in a health/science-related field

• Master of Science Degree in a health/science-related field preferred.

• Doctorate degree in health/science-related field preferred.

• 7 years of combined experience in healthcare products or medical devices required

• Previous 3+ years of medical writing experience in healthcare product or medical device industry required.

• Thorough 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 required.

• Excellent scientific and medical writing skills required.

• Must be able to think analytically, have the ability to 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.

• Demonstrated 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.

• Excellent knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP/EU MDR/MDCG) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology.

• Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation required.

• Good planning and organizational skills, with the ability to adapt and adjust to changing priorities.

• Strong communication, project management and influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.

• Builds strong relationships by fostering open communication, respect and trust.

• Act with a customer service/stakeholder-focused approach.

• Leverages excellent interpersonal keys to achieve desired outcomes.

$95,100 - $204,000 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 location. Individual pay is based on skills, experience, and other relevant factors.