Medical Writer

Kelly Services?? has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Remote** **Medical Writer** at a prestigious Fortune 500?? company.**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "Submit Resume" button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the "Submit Resume" button included within.**Job Title: Medical Writer****Pay: $49.30 per hour****Position Summary**Plan and execute systematic, scientific literature search, review, appraisal and report process for multiple hematology and Urinalysis in vitro diagnostic (IVD) products.Compile and author Scientific Validity (SVR) and Clinical Performance Reports (CPR) incorporating literature findings with clinical performance data from multiple sources in support of IVDR remediation project.Provide critical thinking and analysis of conclusions drawn from clinical evidence to ensure intent of the Regulation is being met.Collaborate with cross-functional team members (product management, regulatory, quality, R, program management) to communicate and escalate status of project milestones.Support cross-functional questions regarding requirements for scientific validity, analytical and clinical performance, PEP/PER, PMS, PSUR and PMPF.Provide critical review of the clinical evidence compiled for the PER by other functional team members to meet the applicable regulatory requirements.Support on time delivery of Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), as needed per project timelines.Preparation of relevant information / responses for regulatory submissions and EUDAMED working with other members of the QA/RA department.Coordinate multiple projects at one time and provide regular reports to Management and other stakeholders as required. Perform additional scientific writing assignments or duties as assigned.**Position Qualifications**Bachelor's degree required, Advanced degree preferred - scientific or medical focused.Minimum 5 years of clinical evaluation, medical or scientific writing experience in an academic setting or the diagnostic, medical device or pharmaceutical industry.Experienced in the use of scientific/clinical research methodology and databases.Knowledgeable of global regulations on clinical evidence required under IVDR or MDR.Ability to work in a fast-paced environment with effective use of prioritization, organization and time management skills.Excellent communication and interpersonal skills with the ability to communicate clearly and concisely in English.Proven problem-solving skills. Excellent technical writing skills.**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.****_Kelly Services?? is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._****Kelly Services is an Equal Opportunity Employer****Why Kelly** **??** **?**Kelly?? Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.**About Kelly** **??**At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.