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Clinical Evaluation Reporting / Medical Writer (Cer)

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

 

Clinical Evaluation Reporting / Medical Writer (CER) – Abbott

Location: Maple Grove, MN | St. Paul, MN | Santa Clara, CA
Work Mode: On-site
Salary Range: $60,000 – $120,000 (may vary by location)


Job Summary:

Abbott is hiring a Clinical Evaluation Reporting / Medical Writer (CER) to support the regulatory clinical evaluation team across its medical device divisions. In this on-site role, you will create clinical evaluation plans and reports for product submissions, collaborating across regulatory, clinical, and engineering teams. Ideal for candidates with 3+ years of experience in medical or technical writing in the medical device or pharmaceutical industry.


Key Responsibilities:

  • Author and contribute to Clinical Evaluation Plans, Clinical Evaluation Reports (CERs), SSCPs, and regulatory documents

  • Analyze and summarize clinical data, post-market surveillance reports, literature, and risk assessments

  • Collaborate with cross-functional teams including Clinical Affairs, Regulatory, Risk Management, and Quality

  • Support clinical and regulatory responses, submissions, and audits

  • Maintain comprehensive knowledge of product portfolios and relevant medical/scientific literature

  • Ensure document quality, consistency, and regulatory compliance (ISO13485, MDR, MEDDEV 2.7.1, FDA guidance)

  • Participate in responses to notified body queries and global regulatory requirements


Required Skills & Qualifications:

  • Bachelor's degree in science, engineering, or a healthcare discipline (advanced degree preferred)

  • 3+ years of medical writing experience in pharma, biotech, or med device industry

  • Knowledge of EU MDR, MEDDEV 2.7.1, and other regulatory frameworks

  • Excellent skills in literature evaluation, clinical data interpretation, and CER writing

  • Strong project management, communication, and cross-functional collaboration skills

  • Proficiency in Microsoft Office Suite and clinical documentation tools

  • Experience in complaint handling, risk management, and product development is a plus


Perks & Benefits:

  • Competitive salary and comprehensive medical coverage

  • Generous 401(k) plan with high employer contribution

  • Tuition reimbursement and FreeU education program

  • Health Investment Plan (HIP) with potential for free coverage

  • Career advancement in a globally recognized medical device leader

  • Supportive, inclusive work culture with recognition for women, scientists, and diversity


Company Description:

Abbott is a global healthcare leader innovating across diagnostics, medical devices, pharmaceuticals, and nutrition. With over 114,000 employees in 160+ countries, Abbott develops life-changing technologies that help people live better, healthier lives. The company is consistently recognized as a top employer for diversity, innovation, and workplace excellence.


Work Environment:

On-site | Available in: Maple Grove, MN | St. Paul, MN | Santa Clara, CA


Call to Action:

Are you a skilled medical writer passionate about regulatory science and clinical research? Join Abbott to shape the future of global healthcare.
Apply now to make an impact through evidence-driven innovation.