Medical Writer/ Clinical Evaluation Reporting

Abbott

3 years

$60,000.00 – $120,000.00

United States

10 Sept. 8, 2025

Job Description

Job Type: Remote Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Abbott – Medical Writer / Clinical Evaluation Reporting (CER)

Company Overview:
Abbott is a global healthcare leader, dedicated to helping people live fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues in over 160 countries, Abbott is committed to advancing health and improving lives.

Why Work at Abbott:
At Abbott, employees can:

Contribute to work that matters, grow professionally, and continuously learn.
Access comprehensive benefits including free medical coverage, retirement plans, and tuition reimbursement programs (Freedom 2 Save student debt program, FreeU education benefit).
Join a globally recognized organization for diversity, inclusion, and workplace excellence.
Work with innovative medical device technologies improving lives of thousands daily, including devices for diabetes, heart disease, chronic pain, and movement disorders.

Location:
Maple Grove, MN | St. Paul, MN | Santa Clara, CA (On-site)

Job Summary:

The Medical Writer / CER provides technical and strategic writing expertise for Abbott’s Regulatory Clinical Evaluation team. This role focuses on authoring Clinical Evaluation Reporting (CER) documents for Neuromodulation, Structural Heart, and Electrophysiology products. The ideal candidate has experience in clinical study management, scientific writing, quality engineering, and risk management, with strong written and verbal communication skills.

Key Responsibilities:

Author and contribute to CER deliverables, including:
- Clinical Evaluation Plans (CEP) / Reports (CER)
- Summary of Safety and Clinical Performance (SSCPs)
- Regulatory responses and related documentation
Evaluate and summarize clinical evidence from clinical investigations, literature, post-market surveillance, and risk management.
Analyze clinical results for product applications and regulatory submissions.
Collaborate with stakeholders across Regulatory Affairs, Marketing Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Risk Management, and Medical Affairs.
Maintain thorough knowledge of assigned products and data sources.
Review IFUs, Patient Guides, Risk Management files, Clinical Evaluation Protocols, physician training materials, ensuring alignment of risk information.
Respond to complex queries from notified bodies and stakeholders.
Ensure compliance with corporate and divisional policies, SOPs, DOPs, and applicable regulations (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, EU & FDA guidance).
Maintain high quality, consistency, and integrity in all documentation.

Required Qualifications:

Bachelor’s degree in a relevant technical discipline, or equivalent education and experience.
Minimum 3 years of technical writing experience in medical or high-technology/biotechnology environments.
Strong written and verbal communication, interpersonal, analytical, and project management skills.
Ability to manage multiple projects, prioritize tasks, and meet deadlines.
Experience working in a matrixed, geographically diverse environment.
Ability to work independently and collaboratively in a fast-paced setting.

Preferred Qualifications:

Advanced degree in science, biomedical engineering, medicine, nursing, or related health discipline.
Experience in experimental design, data interpretation, and clinical data summarization.
Knowledge of medical devices, quality systems, and regulatory standards.
3+ years of medical writing in medical device or pharmaceutical industries; CER experience preferred.
Experience in Clinical Research, Product Development, or Quality in healthcare.
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook.
Experience with complaint handling or operation of medical/diagnostic devices.
Strong analytical skills with ability to manage complex tasks efficiently.

Additional Information:

Travel: Up to 5%
Base Pay: $60,000 – $120,000 (may vary by location)
Division: MD Medical Devices

Learn More About Benefits: Abbott Benefits

Equal Opportunity Employer:

Abbott is committed to diversity and inclusion, encouraging applications from minorities, women, individuals with disabilities, and protected veterans. Reasonable accommodations are provided for qualified individuals with disabilities.

Contact for Accommodation (U.S. residents only):

Phone: 224-667-4913
Email: corpjat@abbott.com

Connect with Abbott:

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Medical Writer/ Clinical Evaluation Reporting

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