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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.