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Clinical Evaluation Reporting / Medical Writer (Cer)

3 years
$60,000.00 – $120,000.00.
10 Sept. 8, 2025
Job Description
Job Type: Full Time 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 – Clinical Evaluation Reporting / Medical Writer (CER)

Location: Maple Grove, MN | St. Paul, MN | Santa Clara, CA
Employment Type: On-site
Base Pay: $60,000 – $120,000 (varies by location)


About Abbott

Abbott is a global healthcare leader helping people live fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues serving more than 160 countries, Abbott is committed to life-changing technologies that improve quality of life.

Why Work at Abbott:

  • Career development opportunities with an international company.

  • Free medical coverage through Health Investment Plan (HIP) PPO.

  • Excellent retirement savings plan with high employer contribution.

  • Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefits.

  • Recognized globally as a great workplace for diversity, women, scientists, and executives.

  • Innovative medical devices that help thousands of people with heart disease, chronic pain, movement disorders, and diabetes.


Position Overview

The Medical Writer on the Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product lifecycle. This role focuses on Clinical Evaluation Reporting (CER) for Neuromodulation, Structural Heart, and Electrophysiology products.

Key Requirements:

  • Clinical study management or design experience, medical/scientific writing, or quality engineering/risk management experience.

  • Strong written and verbal communication skills.


Key Responsibilities

  • Author and contribute to Clinical Evaluation deliverables including:

    • Clinical Evaluation Plans/Reports (CEP/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 data.

  • Analyze results to support product applications and regulatory submissions.

  • Collaborate with Regulatory Affairs, Quality, Clinical Affairs, Risk Management, Medical Affairs, and Marketing teams.

  • Review IFUs, patient guides, training materials, risk management files, and clinical documents for accuracy and regulatory alignment.

  • Respond to complex regulatory queries from notified bodies and stakeholders.

  • Ensure all deliverables comply with internal SOPs and external regulations (ISO13485, ISO14155, ISO14971, MEDDEV 2.7.1, MDR, FDA guidance).


Required Qualifications

  • Bachelor’s degree in a relevant technical discipline or equivalent experience.

  • 3+ years of progressively responsible technical writing experience in a medical or high-tech environment.

  • Strong communication, interpersonal, analytical, and project management skills.

  • Ability to multitask and meet deadlines in a fast-paced, matrixed environment.


Preferred Qualifications

  • Advanced degree in science, biomedical engineering, medicine, nursing, or related health discipline.

  • 3+ years of medical writing in the medical device or pharmaceutical industry (CER experience preferred).

  • Experience in clinical research, product development, quality systems, or healthcare industry.

  • Strong data analysis, experimental design, and clinical data summarization skills.

  • Proficiency in Word, Excel, PowerPoint, Outlook.

  • Experience in complaint handling, diagnostic instrumentation, or medical technology.


Benefits & Perks

  • Health and wellness benefits for you and your family: www.abbottbenefits.com

  • Career growth, learning opportunities, and international exposure.

  • Recognition as a global leader in innovation and workplace excellence.


Abbott is an Equal Opportunity Employer committed to employee diversity.

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