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Senior Clinical Evaluation Writer Jobs (NOW HIRING)

Abbott Laboratories

$90 - $180/hr

## Senior Project Manager/Clinical Evaluation Reporting (on-site)Candidatar-selocations: United States ... Scientific / Medical writing experience is required. In addition, the CER PM will interact cross ...

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Senior Clinical Evaluation Writer information

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$30.5K

$92.6K

$171K

How much do senior clinical evaluation writer jobs pay per year?

As of Aug 15, 2026, the average yearly pay for senior clinical evaluation writer in the United States is $92,559.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,000.00 and $101,000.00 per year, depending on experience, location, and employer.

How does a senior clinical evaluation writer typically collaborate with cross-functional teams during the clinical evaluation process?

A Senior Clinical Evaluation Writer works closely with regulatory affairs, clinical, and medical teams to gather and interpret data for clinical evaluation reports. Regular collaboration ensures that the documentation meets regulatory standards and accurately reflects the device’s safety and performance. The writer often leads meetings to clarify data requirements, address feedback, and integrate input from various stakeholders, making strong communication and teamwork skills essential for success in this role.

What is the difference between Senior Clinical Evaluation Writer vs Clinical Evaluation Specialist?

AspectSenior Clinical Evaluation WriterClinical Evaluation Specialist
CredentialsTypically requires advanced degrees (e.g., Master’s or PhD) and experience in medical writing or regulatory affairsOften holds similar degrees and certifications, with a focus on clinical data analysis and regulatory knowledge
Work EnvironmentWorks primarily on writing and reviewing clinical evaluation reports, often independently or leading teamsFocuses on data collection, analysis, and supporting report development within clinical or regulatory teams
Industry UsageCommonly used in medical device and pharmaceutical industries for regulatory submissionsUsed in clinical research, medical device, and pharmaceutical sectors for compliance and evaluation activities

The main difference is that a Senior Clinical Evaluation Writer primarily focuses on authoring and reviewing clinical evaluation reports, often with leadership responsibilities, while a Clinical Evaluation Specialist concentrates on data analysis and supporting report development within clinical and regulatory teams. Both roles require strong regulatory knowledge and clinical expertise, but their day-to-day tasks and focus areas differ.

What is a senior clinical evaluation writer?

Senior Clinical Evaluation Writers are experienced professionals who create and manage clinical evaluation reports (CERs) and related documentation for medical devices, ensuring compliance with regulatory standards such as the EU Medical Device Regulation (MDR). They analyze clinical data, review scientific literature, and collaborate with cross-functional teams to demonstrate the safety and performance of medical devices. Their expertise helps companies navigate complex regulatory requirements and support product approvals in global markets.

What are the key skills and qualifications needed to thrive as a senior clinical evaluation writer, and why are they important?

To thrive as a Senior Clinical Evaluation Writer, you need expertise in clinical research, regulatory requirements for medical devices (such as MDR/IVDR), and a background in life sciences or medicine. Familiarity with literature review tools, systematic review software, and regulatory databases, as well as experience with CER templates and guidance documents, is typically required. Strong analytical thinking, attention to detail, and effective written communication are critical soft skills for success in this role. These skills and qualifications ensure high-quality, compliant clinical evaluation reports that support product safety and market approval.
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Senior Clinical Evaluation Writer jobs near you
Infographic showing various Senior Clinical Evaluation Writer job openings in the United States as of August 2026, with employment types broken down into 3% As Needed, 72% Full Time, 17% Part Time, and 8% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $92,559 per year, or $44.5 per hour.

Senior Medical Writer - Clinical Evaluation Reporting (CER)

Abbott

Maple Grove, MN • On-site

Full-time

Medical, Retirement

Posted 5 days ago

Abbott rating

7.8

Company rating: 7.8 out of 10

Based on 138 frontline employees who took The Breakroom Quiz

178th of 540 rated manufacturers

Job description

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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
Our location in Maple Grove MN, St. Paul, MN, Plymouth, MN, Plano TX or Santa Clara, CA currently has an on-site opportunity for a Senior Medical Writer, Clinical Evaluation. The Sr. 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 Neuromodulation, CAHF and 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.
What You'll Work On
  • Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF 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), 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.

Required Qualifications
  • Bachelor's degree in a Science, Medical Technology or equivalent technical degree OR an equivalent combination of education and work experience.
  • Minimum 3 years' relevant experience in a related area such as R&D, Technical Product Development, or Quality in a healthcare industry.
  • Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
  • Writing, editing and managing engineering and technical documentation utilized in the development of new products and improvement of existing products.
  • Developing spreadsheets or databases for the capture, assembly, and graphical presentation of metrics.
  • Non-product application validation - Process establishment including metrics definition, statistical analysis and analytical techniques.
  • Experience in complaint handling, operation or service of diagnostic instrumentation, or medical technology.

Preferred Qualifications
  • Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline
  • Experience in experimental design, data interpretation, and summarizing clinical data.
  • Knowledge of division products and or Quality systems and measures
  • 3+ years of medical writing experience in the medical device or pharmaceutical industry or 7+ years general technical writing; CER writing experience
  • Relevant experience in a related area such as Clinical Research, Product Development or Quality or in a healthcare industry.
  • Writing, editing and managing clinical and technical documentation utilized in the development of new products and improvement of existing products.
  • Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills.
  • Understanding of medical technology
  • Excellent analytical skills and ability to manage complex tasks and manage time effectively
  • Proficient with Word, Excel, PowerPoint, Outlook, etc.
  • Experience in complaint handling, operation or service of diagnostic instrumentation or medical technology.
  • Experience working in a broader enterprise/cross-division business unit model.

Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical Writing
DIVISION:
MD Medical Devices
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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