We are redirecting you to the source. If you are not redirected in 3 seconds, please click here.

Staff Medical Writer at Stryker Employment Company, LLC. Location Information: USA. This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.. Role Description. We are currently seeking a Staff Medical Writer to join our Sports Medicine Business Unit, part of the Stryker Endoscopy Division. In this role, you will collaborate closely with cross-functional teams, including Regulatory, Clinical, Quality, and Marketing to ensure the successful preparation of high-quality, submission-ready clinical documents.. 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. . Synthesizes information in support of EU-MDR submissions, required CERs, and annual updates. . Performs systematic literature reviews for medical device groups or sub-groups. . Interprets literature information and synthesizes it in clinical regulatory documents. . 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 for design teams for Clinical EU MDR documentation. . Assists with Clinical Evaluation Strategy for EU Market access. . Coordinates and manages the review process for all documents, leading discussions on document revision. . Challenges conclusions when necessary and independently resolves document content issues. . Ensures timely approvals from all reviewers. . Qualifications. Bachelor’s degree (BA or BS) in a technical and/or scientific discipline required. . 4+ years of Industry experience in medical technology or pharmaceuticals. . 2+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (PhD, Post-doc). . Requirements. Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) is highly preferred. . 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. . Scientific and medical writing skills. . Knowledge of clinical operations, risk management, regulatory submissions and US and international guidelines. . Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation. . Benefits. $87,600.00 - $186,700.00 salary plus bonus eligible + benefits. . Individual pay is based on skills, experience, and other relevant factors.