Medical Writer

POSITION RESPONSIBILITIES/DESCRIPTION:

• 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.