Staff Medical Writer (Remote) at Stryker Fremont, CA

Overview

Staff Medical Writer (Remote) job at Stryker. Fremont, CA. Stryker is currently seeking a Staff Medical Writer to join our Neurovascular Division to be based in Fremont, CA or remotely anywhere within the United States.

Responsibilities

What You Will Do

• As 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.
• Compile 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.
• Responsible for the development and completion of Clinical Evaluation Reports (CERs) for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
• Collaborate cross-functionally to provide input for design teams for Clinical EU MDR documentation.
• Work in a cross-functional team to support clinical study protocols and reports, data summaries from raw data and document strategies.
• Prepare literature searches for drafting document content. Interprets literature information and synthesizes the information in clinical regulatory documents.
• For all documents, coordinates and manages the review process, and leads discussions on document revision.
• Challenge conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.
• Assist in the development of internal procedures, templates and style guides.
• Serve as a subject matter expert within department.
• Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve.
• Assist in the maintenance of the Stryker Endoscopy library for all relevant literature.
• Assist in the process improvements for the medical writing team.

Requirements

• Bachelor’s Degree, preferably in a Scientific Discipline
• 4+ years of combined experience in healthcare or medical devices
• 2+ years of previous medical writing experience in a healthcare product or medical device industry
• Strong scientific and medical writing skills
• 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
• Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.

Preferred Qualifications

• Master of Science Degree or Ph.D./ Pharm. D./M.D.
• Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations
• Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines
• Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation

Compensation and Benefits $87,600 - $186,700 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. 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. Apply tot his job Apply To this Job