Job 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. 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.
Basic Qualifications What you need - 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:
This role will be posted for a minimum of 3 days.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Job Tags
Temporary work, Flexible hours,