Plan and execute systematic, scientific literature search, review, appraisal and report process for multiple in vitro diagnostic (IVD) products. Compile and author 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&D, 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), Periodic Safety Update Reports (PSUR), Post-Market Performance Follow-up (PMPF) and PMS plans and reports, as needed per project timelines. Collaborate with Quality and Regulatory functional partners on scheduling and management of ongoing post-market strategy. Author annual report updates and ensure data gathering, analysis, conclusions and reports are delivered on schedule as per Regulatory requirements. 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.
Valid through: 9/9/2020