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Medical Writer/ Clinical Evaluation Reporting

3+ years
$60,000 – $120,000 annually
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Medical Writer – Clinical Evaluation Reporting (CER) | Abbott (On-site, USA)

Job Summary

Abbott is seeking a skilled Medical Writer specializing in Clinical Evaluation Reporting (CER) to join its global team of healthcare innovators. This on-site opportunity (Maple Grove MN, St. Paul MN, or Santa Clara CA) is ideal for professionals with strong experience in medical writing, clinical research, or risk management who are passionate about advancing medical technology and regulatory compliance in the medical device industry.


Key Responsibilities

  • Write and develop Clinical Evaluation Reports, Plans, SSCPs, and regulatory documentation

  • Analyze data from literature, post-market surveillance, and clinical studies

  • Collaborate with cross-functional teams: Regulatory, Clinical Affairs, Risk Management, Medical Affairs

  • Review and align risk documentation across IFUs, patient guides, protocols, etc.

  • Respond to complex queries from Notified Bodies and regulators

  • Ensure document compliance with ISO13485, MEDDEV 2.7.1, MDR, and FDA guidance

  • Support regulatory submissions, risk reviews, and clinical documentation needs


Required Skills & Qualifications

  • Bachelor’s degree in science, biomedical engineering, or related field

  • Minimum 3 years of technical/medical writing experience in healthcare, pharma, or medtech

  • Strong knowledge of CER writing, ISO standards, and MDR regulations

  • Proficiency with Microsoft Office (Word, Excel, PowerPoint)

  • Strong verbal and written communication skills

  • Ability to work in a fast-paced, matrixed, and diverse team environment


Preferred Qualifications

  • Advanced degree (MS, PhD, MD, or equivalent)

  • 3+ years of medical device industry writing experience

  • Experience in complaint handling or diagnostic instrumentation

  • Understanding of clinical research, product development, or regulatory strategy


Perks & Benefits

  • Base salary range: $60,000 – $120,000

  • Free medical coverage via Health Investment Plan (HIP) PPO

  • Excellent 401(k) with high employer contributions

  • Tuition reimbursement and FreeU education benefits

  • Global career advancement opportunities

  • Recognition as a top workplace for diversity and inclusion

  • Work on impactful products improving global healthcare


Company Overview

Abbott is a global healthcare leader with 114,000+ employees, delivering life-changing technologies in diagnostics, medical devices, branded generics, and nutritionals. With a presence in 160+ countries, Abbott helps people live more fully at every stage of life.


Work Mode:

On-site – Maple Grove MN, St. Paul MN, or Santa Clara CA


Call to Action

Are you a passionate medical writer ready to make a real impact in healthcare innovation? Apply today and take the next step in your regulatory writing career with a world leader in medical technology.