Medical Writer IV

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

Title

Medical Writer IV

Location

Santa Clara, CA, St. Paul, MN, Maple Grove, MN, or Plano, TX 100% Onsite

Duration

12 months

Responsibilities

• We currently have an opportunity for a Clinical Evaluation Reporting / Medical Writer (CER) for Vascular Medical Devices
• The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process.
• Daily activities are related to authoring Clinical Evaluation Reporting documents for the Vascular products.
• Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.
• Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
• Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
• Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
• Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources including literature, clinical data, and medical references.
• Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plan, PMCF Plans/Reports, SSCPs, physician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews, and other processes such as regulatory inquiries.
• Ensures quality in all deliverables and documentation with attention to detail, consistency, and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.
• Can be 100% on site at our Santa Clara, CA, St. Paul, MN, Maple Grove, MN, or Plano, TX.
• If Not PST- may have occasional meetings after 5 pm

Qualifications

• 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 general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills
• Biomedical, sciences, medicine or similar health related discipline preferred
• CER writing experience preferred
• Excellent written and verbal communication skills
• Experience with collaborative, cross-functional teams.
• Excellent analytical skills and ability to manage complex tasks and manage time effectively
• Proficient with Word, Excel, PowerPoint, Outlook, etc.

Consultants Eligible Benefits Upon Waiting Period

• 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)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.