Senior Medical Writer — Clinical Evaluations (CER)

Abbott; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Plan

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts (Health)

Job summary

Abbott is seeking a Medical Writer IV to join our Regulatory Clinical Evaluation team. The role focuses on authoring Clinical Evaluation Reports for vascular devices, managing evidence from clinical investigations, literature reviews, and post-market data.

You will collaborate with Regulatory Affairs, QA, R&D, and Marketing to ensure high-quality CER deliverables and regulatory submissions. The position requires 6–8 years of medical writing experience, a strong science background, and

Qualifications

• Bachelor’s degree or equivalent required.
• 6–8 years medical writing experience required.
• CER writing experience preferred.
• Strong written and verbal communication skills.
• Experience with cross-functional teams.
• Proficiency with Word, Excel, PowerPoint, Outlook.

Responsibilities

• Author Clinical Evaluation Reports (CER) and CEPs for vascular devices.
• Summarize clinical evidence from literature, investigations, PMS and post-market data.
• Collaborate with Regulatory, QA, R&D, and Marketing on CER deliverables.
• Maintain data quality and ensure regulatory compliance (ISO13485, MDR, FDA guidance).
• Respond to inquiries from notified bodies and stakeholders as needed.
• Support related regulatory, quality, and engineering documentation.

Skills

Excellent written & verbal comms

Cross-functional collaboration

Task & project management

MS Office (Word, Excel, PowerPoint,Out

Education

Bachelor’s Degree or equivalent

Biomedical/health sciences background

Tools

MS Office proficiency

Job description

Abbott is seeking a Medical Writer IV to join our Regulatory Clinical Evaluation team. The role focuses on authoring Clinical Evaluation Reports for vascular devices, managing evidence from clinical investigations, literature reviews, and post-market data.

You will collaborate with Regulatory Affairs, QA, R&D, and Marketing to ensure high-quality CER deliverables and regulatory submissions. The position requires 6–8 years of medical writing experience, a strong science background, and