The Davis Companies is searching for a Medical Writer for their large medical equipment manufacturer located in Miami Florida. This position additionally can be hired and work remotely! This is a 12-18 month contract role which will report to the Global Clinical Compliance Manager and is looking to be filled immediately
Responsibilities of the Medical Writer:
- 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.
- 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.
- 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.
- 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.
Requirements of Medical Writer:
- 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.
- Excellent technical writing skills.