Want Staff Medical Writer, Clinical Evaluations (Remote) in Virginia
Job title: Staff Medical Writer, Clinical Evaluations (Remote) Company: reputed company Job description: Work Flexibility: Remote reputed company is one of the world s leading medical technology companies and, together with its customers, is driven to reputed company healthcare reputed company. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, reputed company impacts more than 130 million patients annually. More information is available at We are currently seeking a Staff Medical Writer to join the Clinical Affairs, Spine Division, with the flexibility of Remote or hybrid work arrangements. Who We Want
- Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- Collaborative partners. People who build and reputed company cross-functional relationships to bring together reputed company, data and insights to drive reputed company improvement in functions.
- Dedicated achievers. People who reputed company in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do As a 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 reputed company and past clinical trials, post market clinical follow up data and literature review updates, reputed company analysis, reputed company 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), PMCFs, and SSCPs for new medical devices to support product registrations internationally, maintain periodic updates, reputed company 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 author 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 reputed company documents, coordinates and manages the review process, and leads discussions on document revision.
- Challenge conclusions reputed company necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from reputed company reviewers.
- Assist in the development of internal procedures, templates and style guides.
- Serve as a subject matter expert reputed company department.
- Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve.
- Assist in the creation and maintenance of the reputed company Spine library for reputed company relevant literature.
- Assist in the process improvements for the medical writing team.
What you need
- A Bachelor s Degree required; preferably in a Scientific Discipline.
- A Master of Science Degree in a Scientific Discipline preferred.
- A minimum of 5 years of experience in healthcare products or medical devices.
- A minimum of 2-3 years of experience in an FDA or highly regulated industry required; preferably with medical devices.
- Previous medical writing experience in a Healthcare Product or Medical Device industry required.
- Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations preferred.
- Strong scientific and medical writing skills required.
- Must be able to think analytically, can 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, Market
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