Senior Medical Writer - Clinical Evaluation Reporting (CER)

Abbott seeks a Senior Medical Writer to develop clinical evaluation documentation for neuromodulation, cardiovascular, and vascular products across multiple U.S. locations. The role involves authoring regulatory reports, synthesizing clinical evidence, and collaborating with cross-functional teams to support product development and regulatory submissions. Candidates should have experience in clinical study design, medical writing, or quality engineering with strong communication skills.

Responsibilities

• Author and contribute to Clinical Evaluation Plans, Reports, PMS, PMCF, and regulatory submission documents
• Evaluate and summarize clinical evidence from investigations, literature, surveillance, and post-market data for product applications
• Collaborate with cross-functional teams including regulatory affairs, quality, clinical affairs, and R&D on CER projects
• Review Instructions for Use, patient guides, risk management files, and clinical protocols for alignment and consistency
• Ensure quality, compliance, and data integrity across all deliverables and regulatory communications

Requirements

• Bachelor's degree in science, medical technology, or equivalent technical field
• Minimum 3 years relevant experience in R&D, technical product development, or quality in healthcare
• Strong written and verbal communication, analytical, and project management skills
• Experience writing, editing, and managing engineering and technical documentation
• Experience with complaint handling, diagnostic instrumentation, or medical technology
• Advanced degree in science, biomedical engineering, medicine, or nursing preferred
• 3+ years medical writing in medical device/pharmaceutical industry or 7+ years general technical writing with CER experience preferred