[Hiring] Medical Writer IV @Abbott

Role Description

We are seeking an experienced Medical Writer IV to support the Regulatory Clinical Evaluation team for Vascular Medical Devices. This role is responsible for developing and maintaining Clinical Evaluation Reports (CERs) and related regulatory documentation throughout the product lifecycle. The ideal candidate will have extensive medical writing experience within the medical device, pharmaceutical, clinical research, or healthcare industry.

• Author Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), SSCPs, regulatory responses, and related documentation.
• Evaluate and summarize clinical evidence from clinical investigations, literature reviews, post-market surveillance activities, risk management files, and PMCF data.
• Analyze clinical data and prepare documentation supporting regulatory submissions and product approvals.
• Collaborate with cross-functional teams including Regulatory Affairs, Clinical Affairs, Quality Engineering, R&D, Risk Management, Medical Affairs, Sales & Marketing, and Product Performance Groups.
• Review and maintain consistency across IFUs, patient guides, risk management documentation, PMS plans, PMCF reports, CERs, and physician training materials.
• Support responses to notified bodies, regulatory agencies, and stakeholder inquiries.
• Ensure compliance with applicable regulations, guidance documents, and quality standards.

Qualifications

• Bachelor's Degree or equivalent combination of education and experience.
• 6-8 years of medical writing experience in the medical device, pharmaceutical, clinical research, healthcare, or related industry.
• Alternatively, 8+ years of technical writing experience.
• Strong experience authoring scientific, clinical, regulatory, or technical documentation.
• Excellent written, verbal, analytical, and organizational skills.
• Experience working in cross-functional environments.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Requirements

• CER writing experience.
• Background in Biomedical Sciences, Life Sciences, or a related field.
• Knowledge of ISO 13485, ISO 14155, ISO 14971, MDR, and FDA regulations.

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)