Medical Writer IV

About This Role

This Medical Writer IV position supports the authoring of Clinical Evaluation Reporting documents for Vascular medical devices throughout their product development and life cycle. The role involves strong technical writing skills, the ability to analyze complex clinical evidence, and a collaborative mindset to partner across cross-functional teams.

Responsibilities

• Write and contribute to Clinical Evaluation Reporting deliverables, including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and related documentation
• Evaluate and summarize clinical evidence from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations
• Analyze results to support product applications and submissions
• Collaborate with stakeholders to plan for and support CER-related projects, processes, and deliverables
• Review and ensure alignment across key documents including IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plans, PMCF Plans/Reports, SSCPs, and physician training materials
• Ensure quality and compliance of deliverables by maintaining attention to detail, consistency, and data integrity while following applicable corporate/divisional policies and regulatory requirements (including ISO 13485, ISO 14155, ISO 14791, MEDDEV 2.7.1, MDR, and EU/FDA guidance) and Abbott SOPs/DOPs

Requirements

• Bachelor’s Degree or an equivalent combination of education and work experience
• 6-8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience
• Experience that may include medical/pharmaceutical/medical device writing, clinical research, medical or research industry writing, or a combination of these skills
• Strong written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams
• Proficiency with Word, Excel, PowerPoint, and Outlook
• Strong analytical skills and the ability to manage complex tasks and time effectively

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

Important Details

• Duration: 12 months contract with possible extension
• Schedule: Monday-Friday daytime, 40 hours per week