DAVIS Companies has partnered with a large Biomedical Manufacturing company to identify a Medical Writer to join their team! This role is located in Mn.
PRIMARY RESPONSIBILITIES OF THE MEDICAL WRITER:
- 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&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), as needed per project timelines.
- Preparation of relevant information / responses for regulatory submissions and EUDAMED working with other members of the QA/RA department.
POSITION QUALIFICATIONS OF THE 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.
- Ability to work in a fast-paced environment with effective use of prioritization, organization and time management skills.