Stryker

Compensation

Full Description

Staff Medical Writer (Remote) 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. These include Clinical Evaluation Reports, Post-Market Clinical Follow-up documents, Summaries of Safety and Clinical Performance, and Clinical Study documentation. Work Flexibility: Remote - can be based remotely anywhere within the United States. What you will do • 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 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 the information 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. • 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. What you need Basic 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, along with 2+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (PhD, Post-doc) Preferred Qualifications • 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. $87,600.00 - $186,700.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Learn more about the exciting ways our team is advancing sports medicine on our LinkedIn page: https://www.linkedin.com/showcase/stryker-sports-medicine/. This role will be posted for a minimum of 3 days.