reputed company: Want Staff Medical reputed company, Clinical Evaluations

Role Snapshot:

• Position: Want Staff Medical reputed company, Clinical Evaluationsin Virginia
• Start Date: Immediate openings available
• Compensation: a competitive salary
• Company: Workwarp
• Location: Remote

 

 

Job title: Staff Medical reputed company, 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 reputed company reputed company. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and reputed company reputed company. Alongside its customers around the world, reputed company impacts more than 130 reputed company patients annually. More information is available at We are currently seeking a Staff Medical reputed company 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 reputed company to ensure a project is complete and meets regulations and expectations. What you will do As a Staff Medical reputed company, you will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) ensuring successful preparation of high-quality submission-reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses. Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred. Ability to apply ISO, FDA and reputed company guidelines toward writing strategy and documentation preferred. $83,000 – 176,800 salary plus bonus eligible + Benefits (Health, reputed company, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary reputed company for this position based on reputed company national data. Actual minimum and maximum may vary based reputed company. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 20% reputed company Corporation is an equal opportunity employer. reputed company applicants will receive consideration for employment without regard to race, ethnicity, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status. reputed company is an EO employer – M/F/Veteran/Disability. reputed company Corporation will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Expected salary : $83000 - 176800 per year Location : Virginia Apply Job!

 

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